The Power of Adaptive Learning

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Effective protocol training is essential to the success of any clinical trial, but can be challenging due to the complexity of protocols, presentation of novel procedures and varied staff skill and experience both within and across sites. If training is to ensure optimal performance by all research staff, it must address those challenges. Adaptive learning approaches are uniquely positioned to overcome all these challenges, while also reducing the time burden placed on research site staff by training and re-training.

Adaptive learning is a data-driven approach to instruction that allows material to be adjusted and tailored to meet the individual needs of different learners, rather than a one-size-fits-all experience. This approach uses computer software to create customized experiences and materials based individual learners’ skills and experience level. It provides feedback and resources unique to each person. 

Adaptive learning is typically done using a basic “if A happens, then B happens” approach, a June 2022 article on the Leader.com website explains. For instance, if a learner gives a wrong answer, the system would offer guidance and prompt them to retry; conversely, individuals may skim through areas where they already have mastered the material.

Originally introduced in education, adaptive learning systems have been making inroads into many types of business training systems, as well, including medical fields. In a 2017 blog post on its website, for instance, the New England Journal of Medicine (NEJM) pointed to several common scenarios where adaptive learning is shown to outperform other approaches.

For instance, when learning outcomes—such as performance of a particular medical procedure—have serious consequences, adaptive learning has been shown to better ensure proficiency when the employee performs that procedure on actual patients. It also outperforms other types of training when the intended audience is heterogeneous, with a variety of experience levels and skill sets, a situation that is common in clinical research.

Adaptive learning is also especially useful when time is of the essence. Clinical research staff often complain of being overburdened with administrative tasks like training. An adaptive learning system, with its ability to focus on knowledge gaps and build proficiency faster, can minimize the amount of time busy researchers must spend on training, while still ensuring top performance.

Other scenarios where adaptive learning outperforms other types of training, according to the NEJM blog post, include when training must be repeated over time, which can result in both new and old information being presented to the same individuals repeatedly, and when information is changing frequently, which is always the case in evidence-based medicine and clinical research.

This ability to essentially skip known material or to “test out” of some training where they already are proficient could be a particular boon in the clinical research arena. The time needed for training, particularly for re-training on the same material, is a frequent complaint, as indicated by a 2020 HealthStream survey on adaptive learning. This approach ensures that more skilled and experienced learners focus strictly on novel instruction.

Pick the right platform for adaptability

Taking advantage of the pluses offered by adaptive learning requires the right training platform. For instance, Pro-ficiency’s simulation-based training platform allows for adaptive learning in several ways. The system’s proprietary content authoring tool enables rapid construction and maintenance of branching logic, “choose your own adventure” learning modules (see Figure 1 below).

Figure 1: Branching Logic in Pro-ficiency’s Platform

In this way, all learners can take slightly different paths through the learning module, depending on their baseline capabilities and knowledge. The system will train individuals only when they make mistakes. When they make correct choices, they can quickly advance to the next challenge. This can reduce training time by up to 50%.

Further, each role on a study team has customized learning content in the system, based on job-specific target competencies. In this way, the platform adapts to the specific needs of each participant and team member of the study or internal sponsor team. This differs from video or slide training, where a one-hour training session will always take one hour, regardless of an individual learner’s baseline knowledge and skill sets.

The system also offers predictive analytics that enable detection of trends in performance data. This data can predict strengths and weaknesses in site staff, CRA and monitor competencies, allowing it to adapt smoothly to the needs of the entire cohort of learners.

Figure 2, below, provides an example of this capability. It shows performance results from three research sites that completed simulation-based training for a Phase 3 protocol. The vertical columns show the competencies while the horizontal rows represent the individuals who have completed the training. The trifurcation indicates the three separate sites. 

A grey checkmark indicates that the individual passed that challenge with no need for mentoring or training. Figure 2 indicates that the first site did very well across the board, as did the third site, except for the CRA three rows from the bottom. This information lets study leadership know that the CRA at the third site requires additional attention and training. The middle site, on the other hand, is struggling except for one individual; study leaders can leverage the high performance of that person to act as a champion to mentor and guide other team members.

Figure 2: Predictive Analytics Generated During Pro-ficiency Training
This performance data can also highlight areas of a protocol that may be more challenging. Figure 2 shows such a situation, with one particular competency that everyone struggled with, high and low performers alike. That competency will require more targeted remediation, which the system will provide.  

And the study team is not the only group that can benefit from this adaptive learning approach. Study participants can also experience similar training, via Pro-ficiency’s ProPatient product.

Because Pro-ficiency’s simulation-enabled performance management system is bespoke-built for clinical trials, it also offers capabilities to solve problems that most sponsors have not yet even identified. One of these is amendment management. Every protocol amendment increases complexity in the study by creating a new cohort within the staff for employees trained on A1 versus A2 versus A3, and so on. High staff and CRA turnover further add to this complexity.

The standard response to this challenge is to force constant retraining on affected sites or internal teams as amendments may require. The Pro-ficiency system, however, tracks exactly which competencies and which version each learner has completed. This allows retraining to focus only on new material, which dramatically reduces training burden on research staff.

`The final point concerning adaptive learning relates to how the data generated from the training system helps study teams adapt their monitoring plans. For instance, data like that shown in Figure 3, below, informs the study team as to which sites are more likely to generate study errors. This allows monitoring resources to be more effectively targeted—or adapted—to the riskiest sites at the beginning of the study. Sponsors don’t have to wait for problems to occur; they can address weak areas proactively.

Figure 3: Predicted Error Rates Via Pro-ficiency Training

This also extends to global considerations where culture, language or other country-specific issues may impact research staff performance. Pro-ficiency provides a dashboard that displays the predictive performance analytics in real-time and spread geographically according to the distribution of sites and teams.

Training in the clinical research industry will continue to pose a variety of challenges, including time constraints, ever-changing information due to protocol amendments or new scientific evidence, novel procedures that fall outside research staff experience and a broad range of skill level both within and across research sites. Any training program lacking the agility to handle these challenges is doomed to failure, leading to mistakes and delays in getting investigational products to market.

Adaptive learning offers a powerful solution to those challenges. By adopting training platforms with solid adaptive learning features, such as that offered by Pro-ficiency, new product sponsors can help ensure a faster, smoother path through the clinical research process.

To learn more about Pro-ficiency’s simulation-based training solution, please visit our  website: https://pro-ficiency.com/simulation-training

Unlocking Clinical Site Efficiency with Simulation-based Solutions

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The need for site efficiency is greater than ever in light of the ever-growing complexity of clinical trials and the requirements placed on-site teams. Unfortunately, the oversaturation of new solutions in the industry means that sponsors and CROs often invest in tools that cost them valuable time, money, and efficiency.

Outdated training methods, clunky system plug-ins, and lack of insightful analytics all place a large burden on sites and site teams throughout the trial process that could be vastly improved with solutions like those Pro-ficiency offers.

Protocol Training

While cheaper and more widely available, traditional didactic training methods are quite inefficient at actually training site teams. Oftentimes, the training consists of extensive and unengaging PowerPoint presentations that do not prioritize critical information, which means researchers are challenged to weed through mountains of information to remember key details. And these generic, one-size-fits-all trainings fail to address the challenges of constant staff turnover at sites. Without a targeted and efficient training methodology, site staff are left to shoulder the burden of inadequate and generic training programs, delaying the implementation of study-related actions. The result is typically more study deviations, re-training, and delays.

Pro-ficiency’s simulation-based protocol training uses virtual AI-driven methodology to simplify the protocol into key decision areas that an investigator has to make so site teams can train with the protocol hands-on and specifically target complex decisions they will need to make during the study. Combined with study tools like quick reference guides, job aids and patient visit guides, learners can improve their understanding of the protocol and increase their retention of vital information, reducing the number of deviations and delays – a much better solution to improving site performance than traditional methods.

Pro-ficiency’s prescriptive analytics also help to identify key risk areas and training issues proactively, so site managers can intervene where necessary. These performance-based analytics spotlight specific individuals struggling with training or specific topics posing issues for many people, allowing site managers to provide additional clarification and resources to the team. 

Workflow Integrations

The clinical trial technology landscape has an abundance of products, and due to the complexities of modern-day trials, site teams are working with dozens of these systems at once. According to Florence Healthcare, 42% of sites login to more than six platforms for an average study, and 40% say a lack of integrations prevents them from adopting new technology. Having to log in to each system individually not only poses a security threat but is also cumbersome and takes up valuable time. 

Pro-ficiency’s SSO and API solutions can integrate with any available system to further reduce the burden on sites and provide secure access with minimal disruption to the process. Additionally, Pro-ficiency’s newly released all-in-one training hub provides seamless access to educate, engage and enable trial sites to become more efficient.

Proactive Efficiency

Very often, research teams are unable to identify gaps and deviations in trial design until the trial has already begun, causing further delays and increasing expenses. To combat this challenge, Pro-ficiency’s protocol optimization methodology translates a complex, scientific, and regulatory protocol into a visual simulation of the patient journey and site operational flow for the trial. This allows site teams to understand the full reality of the trial, see potential inconsistencies, anticipate resource and operational requirements, and make adjustments prior to finalization. 

This solution is most valuable at study start-up, though has value in mid-study implementation for better communication and comprehensive operationalization of a protocol’s time-sensitive steps.

Pro-ficiency’s value of site efficiency guides the innovation of every product and is part of our commitment to providing a better experience and better outcomes to our customers.

Click here to learn more about Pro-ficiency’s commitment to increasing site efficiency and reducing the burden on sponsors and site teams.  

Rethinking Training: Achieving Competency in Less Time and With Better Results

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Training for clinical research staff that focuses on complete comprehension of a protocol and its goals can be a key factor in avoiding errors and protocol deviations during the course of a study. In fact, training, if done right, offers a unique opportunity to predict potential problems and address them before they occur.

At its foundation, training provided to research site employees is intended to ensure competency. Competent staff are less likely to make errors, meaning that the risk of protocol deviations goes down as site employee competency goes up. And reduced deviations can help to avoid study delays and keep costs—which have been trending upward, as have trial timelines—under control.

So it may seem self-evident that training provided to staff at clinical research sites is a critical opportunity to ensure peak performance and prevent protocol deviations that can derail a study.

But the clinical research industry traditionally has viewed the need for training as, at best, an item to check off a list in order to get a study off the ground and, at worst, a burden to sponsors and research sites alike.

This outlook has developed over years of a push-pull dynamic between sponsors’ need to comply with regulations that mandate training on study protocols and GCPs and sites’ desire for shorter training that poses a lesser burden to research staff. For instance, CenterWatch reported in August 2020 that training was a growing pain point for research sites, which were overwhelmed by growing administrative responsibilities, including undergoing GCP and protocol-specific training.

The FDA requires that all research personnel be adequately trained for their roles. The agency is largely focused on GCP compliance, as well as adhering to the protocol. And sponsors often focus on training as a risk mitigation exercise to ensure that they can demonstrate to the FDA that they have met their regulatory obligation in this area. In other words, it’s not uncommon for a sponsor or CRO to create training programs designed to do nothing more than check the “training” box on FDA paperwork.

And in an effort to cover all training bases, sponsors and/or CROs tend to provide training materials that are both massive in volume and overly generalized. One reason sites view training as a burden is the massive amount of information—often in slide decks numbering in the hundreds—sponsors tend to dump on researchers, rather than engaging with different roles and clarifying what is most important for a particular study.

A better approach would be to develop training that truly provides opportunity for individuals in clinical research to acquire, retain and apply knowledge.

Boost competency, reduce errors

Sponsors need sites to execute clinical trials as close to perfect as possible. In order for this to happen site employees need to consume content that will help them understand. But that is not enough to achieve the goal of optimized performance. Research staff also need to have enough understanding to ensure that they consistently make good decisions.

And that can’t be achieved through a slide deck, lecture or webinar. Research staff must be engaged with the content and provided an opportunity for “perfect practice,” where errors are caught and corrected before real-life stakes are in play.

Providing training in a simulation format can help solve these problems in several ways. Simulation-based training, such as the program offered by Pro-ficiency, provide research staff with hypothetical situations similar to those they will face during the study. They are then able to actually practice key tasks and procedures required under the protocol, getting guidance throughout the process to help ensure they make decisions correctly, in compliance with the protocol.

Additionally, the immediate feedback on mistakes that is built into Pro-ficiency’s method avoids the risk of staff developing “muscle memory” that is incorrect for performance of critical tasks. This can be particularly important when a protocol requires procedures that are different from the standard of care a site is used to practicing.

The dashboard of results like that provided by Pro-ficiency can highlight any weak areas to both sites and sponsors, allowing additional concentration on the troublesome areas—whether a tricky procedure or a less-experienced site or individual—and address problems before they occur in a real-life clinical trial. When training provides these types of analytics, sponsors can track where mistakes are most common and take appropriate action.

Actions available to sponsors in these cases can include providing an additional training module on a particular procedure or giving extra help and training to struggling sites or individuals.

It’s impossible to take a one-size-fits-all approach to competency management. The goal is to reduce errors as much as possible. But when they do happen, each situation should be evaluated independently. Additional training can solve some problems, but in other cases, a sponsor may be looking at a wrong investigator or site, for instance. In other words, improving human performance can save money and time.

This approach to training also lets research staff move at their own speed, whizzing through tasks in which they already are proficient and spending more time on novel, protocol-specific procedures.

But a high error rate is not always a negative during training. For instance, one Pro-ficiency client applied training for a highly complex protocol that was challenging for sites. When employees initially participated in the training, the analytics indicated a high error rate. However, once the study began, deviation rates were not high. This would seem to indicate that the training allowed them to safely make mistakes, correct them and better learn how to execute the protocol properly.

And for particularly complex or novel procedures, training can be repeated for research physicians or others responsible for those tasks. For example, the sponsor of a study where the protocol required novel needle path planning opted to provide the training for that procedure early to allow ample time for physicians at the research sites to become comfortable with the new method. Analytics showed that errors were common as sites went through that training the first time.

But the sponsor re-presented the same training just before the first patients would need to undergo the procedure. And at that point, the errors were significantly reduced, and performance during the clinical trial much improved.

And those two factors—an opportunity to practice the protocol in a consequence-free environment and getting real-time coaching during the training—are central to effective training that boosts staff competence, avoids protocol deviations and checks the regulatory “training” box.

Timelines for clinical trials are growing longer and costs are getting higher. Protocol deviations can be a major contributor to increases in both cost and time. Moving the needle toward fewer errors and deviations by even just 10% could make a significant difference in the resources needed to complete a clinical trial. And well-developed, well-applied, simulation-based training, while it can’t guarantee the perfect study, does offer the potential to alleviate some of these expense factors later on.

Measuring Training ROI in Clinical Research

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Clinical trials are vital to the future of medicine and pharmaceuticals. Many of them are literally matters of life and death, studying the effect of potentially life-saving drugs or researching the impact of devastating diseases. So, why is it that the training of study moderators and site teams is treated so nonchalantly?

The traditional methods used to train these teams are extremely outdated, inefficient, and ineffective. This leaves site teams unprepared for the realities of the trial, increases protocol deviations, and drastically increases the overall cost of the study.

But many sponsors don’t even measure the ROI (return on investment) of the training they administer to determine how it’s impacting their trials and bottom line. Unfortunately, CRO-managed studies actually benefit from increased deviations because they are also tasked with fixing them, which lengthens the study and makes them more money. Recent data from the Tufts Center for the Study of Drug Development revealed that a typical phase three trial has 120 protocol deviations affecting 30% of the study subjects, but CRO-managed trials have 64% higher protocol deviations affecting 70.8% of the study subjects. This is not a coincidence. Each amendment made to a trial costs approximately $500,000 to correct, so there is little incentive for CROs to optimize training and reduce errors despite the high stakes of many clinical trials.

Nevertheless, as sponsors evaluate all elements of their clinical research, there is a reliable method for determining the ROI of their training.

The Kirkpatrick Model

The Kirkpatrick Model was developed in the 1950s by Donald Kirkpatrick, a professor and training specialist, to accurately measure training effectiveness. There are four levels sponsors can use to evaluate their training methodology:

  • Level 1 – Reaction
    The degree to which participants find the training favorable, engaging, and relevant to their jobs. The current training in our industry is severely lacking, consisting of mind-numbing powerpoints and lectures that don’t do anything to engage the participant.
  • Level 2 – Learning
    The degree to which participants acquire the intended knowledge, skills, attitude, confidence, and commitment based on their participation. Current training methods are very ineffective at building retention, leading to higher rates of protocol deviations during the trial.
  • Level 3 – Behavior
    The degree to which participants apply what they learned during training when they are back on the job. If they are prepared with adequate training, site teams will be able to retain information better and act more appropriately in situations, reducing errors across the board.
  • Level 4 – Results
    The degree to which targeted outcomes occur as a result of the training and the support and accountability package. This is the level where ROI can be measured.

Unfortunately, sponsors don’t often measure the ROI of training at all. In fact, they barely test site teams for retention after training is administered. The only standard sponsors are required to meet by the FDA is simply to administer the training, not determine how well it works.

But deviations can have tremendous impacts on the bottom line of a trial and on the well-being of the patients involved, so even without calculating the exact ROI, it’s obvious that improved training would be of benefit to sponsors in the end, even if it calls for higher initial investment.

The ROI of Simulation-Based Training

Take the Boeing 737 Max, for example. Normally, pilots are required to complete thousands of hours of simulation training to fly, but they were not required to do so for this new aircraft due to the high cost. But when faced with emergency crash situations, the pilots were unable to perform basic procedures that would have shown up in simulation training and could have saved hundreds of lives.

Sure, it would have cost Boeing several hundred million dollars to train these pilots in a simulator, but what is that compared to the cost of those devastating crashes?

Why then are clinical trials, often testing life-saving procedures and putting patient health at risk, treated differently? Well, many sponsors don’t even know it’s possible to measure the ROI of training, and simulation-based training is a larger upfront cost without an immediate return, which deters many from utilizing it.

Nevertheless, the industry is slowly changing to adopt simulation-based training more broadly as the ROI is discovered. Good training should result in about a 5,000% ROI, and in fact, we estimate that Pro-ficiency’s simulation training solutions will save $1 – 10 million per study by better preparing site teams, reducing deviations, and mitigating the need for costly amendments to be made mid-study.

All training should be designed to have a positive business impact. The more that sponsors adopt simulation-based training, the more data they will be able to gather and analyze, allowing them to realize the tremendous ROI associated with training their site teams using real-world scenarios.

To learn more visit: https://www.pro-ficiency.com/simulation-training/

Business Expansion in the Digital Age

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No business or industry has gone untouched by the widespread impact of COVID-19. Whether it was business development, talent acquisition, or company culture, every organization had to adapt in some way to weather the storm. In fact, many organizations were still reeling from the effects of the omicron variant just a few months ago in early 2022.

But now, as we look back on the past three years from the post-COVID era, there are many lessons to be learned and many opportunities to take advantage of as businesses seek to recover, grow, and thrive moving into the future.

Our industry and the industries we serve, for example, have faced several challenges over the past few years. From a business development perspective, there was a sudden reduction in trade shows and in-person events a few years ago, impacting our ability to make connections with customers and forcing our sales team to adapt virtually. On a larger scale, the life sciences industry as a whole is struggling with talent deficiencies and increasing costs, all of which impact outside partners like Pro-ficiency. Studies are harder to staff, sponsors are struggling with manpower, and business expenses are going up tremendously.

When we think about the strategies and tools businesses can use to make the most of this unique environment, a few things come to mind…

Focus on Customer Satisfaction and Innovation

Focusing on customer satisfaction and bringing innovative offerings to the table can mitigate gaps caused by a dip in new customer acquisition. In a world where business expenses are skyrocketing, sponsors/CROs are more than ever on the lookout for cost-cutting strategies. And at Pro-ficiency, we strive to provide such a valuable experience to customers that they always come back to us for their next study.

To ensure our customers’ satisfaction, we invest heavily in our technology and our team to provide customers with tools that provide undeniable value to their business. Most recently, we expanded our sales team, acquired a product development team for updating and creating new products more rapidly, and launched the use of avatars to help improve throughput and capacity for building simulations. We also have a whole series of product initiatives in the works to facilitate payments, improve analytics, and allow study participants to more easily connect – all expected to roll out in 2023.

By investing in the right priorities, we are able to deliver for our customers and make future acquisitions easier.

Embrace Virtual

Pro-ficiency has always been a lean and virtual organization, so we were well-positioned to tackle the pandemic from day one, needing to make much fewer adjustments than other larger businesses that operated primarily in person. Now that we are on the other side of the pandemic, it’s obvious that virtual is the way forward. For the sake of business development and company culture, embracing this reality has proven to be better at reducing costs, maintaining employee satisfaction, and delivering results than even the old pre-covid way of conducting business.

With the right tools and structure, employees can be much more efficient, product development can be streamlined, and building your team from a much larger pool of candidates can offer unlimited opportunities.

Invest in Company Culture

Building a meaningful company culture where a team can thrive is more important than ever as employees have unlimited options at their fingertips. Making this a top priority will pay off tenfold down the road as companies look to expand and grow.

At Pro-ficiency, we’ve been very fortunate to attract top-shelf talent. A lot of that is because people want to be involved in what we do. Being part of the solution to accelerate therapeutics for a rare disease is very noble work, it’s meaningful. We also work to create a positive day-to-day environment for our team by connecting personally with virtual tools, sending regular updates on company progress, and getting together in person whenever possible. All of these efforts go towards creating a culture that will allow Pro-ficiency to grow in this new world.

Overall, businesses that adapt to the new digital landscape and prioritize customer satisfaction, innovation, and company culture will be well-positioned to thrive in the post-COVID era.


Visit our website to learn more about Pro-ficiency: https://www.pro-ficiency.com/about/

Analyzing Protocol Deviations Before Retraining

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Protocol deviations can cause significant problems during clinical trials, forcing sites and sponsors to direct time and resources toward investigating and addressing them, potentially delaying completion of the study. And failure to address a deviation properly can lead to recurrences, costing the study more time and money.

What constitutes addressing a deviation properly? Any corrective and preventive action (CAPA) plan aimed at a deviation must be founded on a thorough root cause analysis, a step that the research industry seems prone to skip. Instead, a common response is to throw more training at the problem in the interest of checking a box on a form and moving forward quickly.

But taking a pause when a deviation occurs, performing a root cause analysis to identify the real source of the problem and tailoring a CAPA response specifically to that problem or set of problems will serve sites and sponsors better than just retraining site personnel on autopilot.

Root cause analysis is considered to be an integral part of overall quality principles, and is addressed in regulatory guidance. For instance, the FDA noted in a 2013 guidance document that a sponsor should have a “Processes to ensure that root cause analyses are conducted where important deviations are discovered and that appropriate corrective and preventive actions are implemented to address issues identified by monitoring.”

Similarly, ICH guidelines, Good Clinical Practice: Integrated Addendum to ICH E6, include specific requirements for a root cause analysis to be conducted in the event of a protocol deviation.

A frenzy often surrounds occurrence of a protocol deviation, focused on checking off the corrective action box and filling in the right forms. For many sponsors and research sites, the knee-jerk response to a protocol deviation is to retrain the erring staff member. This is an easy cause to address; site staff can be retrained and this is easily documentable. But retraining may not work to prevent the same problem from recurring.

But lack of training isn’t always the right answer. And if the problem recurs after retraining, one of two conclusions can be drawn: Either the problem wasn’t rooted in insufficient training or the training was ineffective. While inadequate or poorly understood training can contribute to deviations, it is not always the root cause. Other possibilities include issues with a process, with the technology used, or with communication among personnel, for instance.

In some cases, there may be multiple factors contributing to deviations; each of these must then be addressed effectively.

Applying the five whys

Thus, research sites and sponsors would be better served to pause and consider before moving to the easiest option—often retraining. But the preventive part of CAPA is just as important as the correction part; pausing and taking the time to conduct a root cause analysis can mean the difference between recurring deviations that must continue to be dealt with and a complete solution that forestalls future problems.

The only way to determine for sure that a deviation is rooted in training or another problem is to map out the process in fine detail. In this way, sites and sponsors can rule out potential causes and zero in on the real reasons behind a deviation.

A variety of methods may be applied. One of the most widely used approaches is the “five whys” method. By asking the question “why” of each stage of deviation evaluation, sites and sponsors can gradually work down to the root cause of the problem.

For example, the deviation may be that a site is not consistently performing protocol-required EKG assessments at patients’ baseline visits. The five whys approach can be used to dig down to the true reason these assessments have not been done, starting with the simple question: Why don’t sites comply with this requirement?

A possible answer is that the site doesn’t understand the measurement criteria, an answer that leads to the question: Why doesn’t the site understand? If the answer is that the site hasn’t been trained, that also begs a “why” question.

More often, training has been provided, but it hasn’t proven effective in ensuring the site’s understanding of how to perform the EKG assessment. When “why” is asked to that answer, several possibilities arise, including:

  • The training was so long ago that site staff forgot the instructions for this assessment;
  • The training didn’t focus on how to conduct the measurement;
  • The training approach wasn’t effective; or
  • Site staff simply weren’t paying attention during the training.

Depending on the answers at this level, the site and/or sponsor continue moving forward, asking “why” until it is no longer applicable. It may not always be necessary to go five layers deep. With regard to the potential answers above, for instance, the first issue could be addressed by providing job aids to jog staff memories when doing the EKG assessments. The last three points are common problems associated with traditional slide-and-lecture training that is too broad, not engaging enough and lacks feedback on absorption of information.

Additionally, root cause analyses also need to look beyond an individual incident. They must look at patterns and trends. This focus may reveal that a deviation was a one-off issue at a single site with one or a few employees. Or it could show that a given site has certain problems and root causes, or one particular region or sites working with a specific CRA. All of these situations must be handled differently to correct the current deviation and prevent future ones.

When is more training needed?

In some cases, insufficient training can be the root cause of a problem. Even in those instances, however, effective correction and prevention of future incidents should not rely on simply re-doing the same training. It’s important to make sure the right training is targeted to the right people in the right format at the right time and in the right way.

When considering whether training really is the root cause of a deviation, there are several considerations, including how the training was done and who conducted it. Some types of training can be more effective than others. The traditional slide-and-lecture approach to training may not be the most effective way to ensure correct performance of all protocol-mandated tasks, for instance. A simulation-based approach that guides staff through real-life scenarios may be more effective.

Who conducted the training may also be a factor. It’s not uncommon for a CRA to provide training, but this individual likely lacks training skills or credentials. A qualified trainer or team can mean the difference between training being well-absorbed or forgotten.

Use of a training matrix, to help develop effective, simulation-based training modules for clinical trials, can help guide development of effective training programs for both initial training and retraining that might be needed to address deviations.

And in some cases, the training may have been on point, but if a significant amount of time has elapsed between the training and start of enrollment at a site, staff may struggle to recall perfectly how some tasks are to be performed, particularly any that may differ from standard of care. In such cases, retraining might be helpful, as might job aids that staff can refer to when conducting the clinical trial.

Additionally, it’s important to consider root cause analysis to be a continuous process, not just a one-time event that’s done and checked off. Sites, sponsors and monitors must monitor that a corrective action worked to effectively fix the current deviation, and that preventive measures are able to keep similar deviations from happening during the study. And that means there must be methods for measuring the performance of the training or other intervention.

In the case of training, for instance, a simulation-based approach that provides both immediate feedback to research staff about their performance and a dashboard of information showing sponsors and site leadership how well staff perform in various areas can provide that means of measurement.

Developing a training strategy

All of this should be incorporated into a risk management strategy that includes an up-front risk assessment for each protocol. Part of a proactive risk strategy should include going through the exercise of anticipating where a protocol is likely to see deviations. This information can be gleaned from previous work, from questions posted by sites during feasibility assessments and from a thorough mapping of the entirety of the protocol, such as that performed as part of Pro-ficiency’s Pro-Active Protocol service. And this information can help to identify where training can be focused to prevent deviations.

Many sponsors don’t really have a training strategy. They tend to look at it as a box on a list that needs to be checked off, so they conduct training, but don’t really think about strategy. But this can lead to ineffective, one-size-fits-all training. A better approach would be to parse out who the specific audience is and what they need for each training effort. This includes whether a site is experienced—in the area of study, with clinical research generally and in working with the specific sponsor—or not; training needs will be different for a site new to clinical research versus one that conducts several trials each year.

This type of training assessment can be supported by creation of a training matrix that looks not only at site experience, but also at global regions, where language and cultural differences can cause confusion, and at specific roles within a clinical trial. A PI will have different training needs than a pharmacist, for instance. Targeting potential areas for misunderstanding up front can be more effective.

Sponsors can perform this work themselves or engage a company like Pro-ficiency to thoroughly evaluate the training needed, including focused modules for different staff. Coordinators, pharmacists, interventional radiologists, investigators and research nurses, for instance, will each be responsible for specific protocol tasks and procedures; focused modules for each position that simulate real-life scenarios relevant to each role can be most effective in ensuring that all positions fully understand how to perform protocol tasks.

And sites need to own their own quality systems, including thorough analysis of deviations and CAPA procedures. Sponsors can provide support via training and resources.

A similar approach can be applied to re-training, if that is needed to properly address a deviation. The focus should be on what problems the training is meant to solve, who needs that training and how it should best be presented to enhance understanding and avoid future deviations.

This takes time and effort and also means that existing training must be adjusted. But if the work isn’t put in up front, it will need to be put in later, after deviations have occurred.

Protocol deviations will happen. Companies can reduce the risk of deviations by taking a risk-based, proactive approach to training that includes a well-thought-out training strategy. Application of carefully targeted training modules that provide performance feedback to both research staff and study sponsors can help ensure that all employees get exactly the training they need to fully understand their roles in enacting the protocol.

And when a deviation does occur, a careful root cause analysis must be prioritized above a fast, knee-jerk response. Failure to conduct this analysis and craft CAPA plans tailored to address the true causes of the deviation means that researchers will end up chasing the same problems, treating symptoms rather than the true cause. Retraining may be part of the issue, but all other potential causes must be considered and dealt with.


Visit https://www.pro-ficiency.com/simulation-training to discover how our simulation training can better your clinical sites.

Preemptive Protocol Analysis: Reducing the Need for Retraining

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When things go wrong during a clinical trial, retraining of staff is often the go-to response to correct the problem. But rather than using training as a band-aid for every protocol deviation that occurs, organizations would be better served by investing up-front in protocol analysis to anticipate areas where protocol deviations or other problems are likely to occur, and then designing training that will trouble-shoot those issues in advance.

While staff retraining is the knee-jerk reaction to a protocol deviation or problem, training is not always the root problem. There could be issues with a site’s operational process, technology or communication, among other things.

If done properly, training can be designed that anticipates these potential problems and focuses its efforts on ensuring that challenging parts of a protocol are fully understood. This depends upon a thorough protocol review, with specific input from patients and research sites to identify anything that is unclear or impractical.

This information can then be used both to refine the protocol into something difficult to misinterpret and to develop a training program that truly meets site’s needs, along with job aids where it makes sense to support research staff in making the correct decisions with every patient and every procedure.

Correcting protocol deviations can be a costly and time-consuming process that leads to study delays, extra costs and potential impact on study data. And deviations are far from uncommon. According to a study published by Tufts Center for the Study of Drug Development (CSDD) last year, Phase 2 and 3 protocols have a mean of 75 and 119 protocol deviations, respectively. And the FDA’s most recent BIMO metrics report lists protocol deviations or failure to follow the investigational plan as the most common observations listed on Form 483s after a BIMO inspection.

But deviations aren’t the only issue of concern. Protocol amendments can add significantly to the cost and duration of a clinical trial. CSDD has estimated that a single protocol amendment to a typical Phase 3 protocol can add three months of time and more than $500,000 in cost to a clinical trial, on average.

And amendments are on the rise. CSDD data indicates that the frequency of protocol amendments is increasing. During the 2018-2020 period they increased significantly compared to the 2013-2015 period. Nearly 78% of Phase 2 and 69% of Phase 3 protocols had at least one substantial protocol amendment; total amendments per protocol averaged 2.7 for Phase 2 and 3.3 for Phase 3.

Both protocol deviations and amendments potentially impact patient retention, investigative site commitment and the completeness, accuracy and reliability of study data.

But none of this data means that protocol deviations and amendments are just part of doing business for the clinical research industry. Rather than the traditional reactive response to problems arising during study conduct, sponsors could take a more proactive approach and trouble-shoot problems before a trial even begins.

Communication, analysis, then training

And this does not begin with protocol training. The first step to avoiding deviations and amendments is a thorough analysis to understand what a day in the life of a patient or research site would look like under the protocol.

For instance, many logistical issues can become major pain points for research sites and patients when it comes to putting the written protocol into action. The time window required for drug administration or patient visits is one example. A protocol may provide a window of 10 minutes to administer a drug, but that window may not be workable for all sites. If a particular site has patient visits occurring on one side of a large campus while the research pharmacy is on the other side, for instance, that 10-minute period may be insufficient.

If a drug takes 45 minutes to thaw before being provided to a research nurse to administer, that will add to the time needed to prepare each dose for each patient. Further, if the pharmacy is at a distance from the clinic, the time to deliver that drug also must be considered. Other factors include the time needed for the nurse to prepare the patient and prepare the drug in an infusion bag. The whole process could take well over an hour.

Similarly, the amount of time and effort required to attend visits and otherwise participate in a clinical trial can have a big impact on patient willingness to enroll. Protocols that include lengthy visits for tests and treatment can put patients off, as can lengthy or frequent trips to the clinic. Remote visits may ease some of that resistance for some patients, but not all; some may be unwilling to have strangers coming to their homes.

And on the staff side, long or frequent visits can raise questions about when staff must be available.

In essence, a protocol analysis needs to consider what is practical for patients and for the sites that will be conducting the clinical trial. This sort of analysis requires input from both patient groups and the enrolling sites. While it’s becoming more common for sponsors to include patient advocacy groups input into protocol design, that is just the first step. They also need to get feedback from the sites that will implement the protocol to learn what is and is not operationally feasible.

With that operational input, including what parts of a protocol may be burdensome or impractical for patients and sites, a sponsor can refine its training to fully address any areas that might differ from a site’s normal standard of care or otherwise be open to interpretation.

Solutions such as Pro-ficiency’s Protocol Optimization methodology can be used to get a thorough interpretation of a protocol, identify potential problem areas or pain points and provide a visualization that helps make clear what the journey through a clinical trial will look like for patients and research sites.

The mapping out of tasks and timelines in the protocol is especially important. Without that visualization, it is easy to miss all the steps that have to happen with each procedure or patient visit. It also helps to uncover any inconsistencies that might exist in the protocol. A visual mapping of a study’s operational flow, on the other hand, will easily reveal any issues.

If that process flow is animated, as provided by Pro-ficiency’s Protocol Optimization solution, it can become even more clear. In essence, a sponsor can see in a few minutes the whole of the study experience for the sites and patients in a way that will have a visceral impact and better enable both refinement of the protocol and development of effective training.

By approaching protocol optimization in this way, sponsors can ensure that training reflects perfectly the experiences research staff will have in implementing a given protocol.

And this effect can be expanded by incorporating simulation-based training. Any novel or unusual procedures can be more carefully illustrated and explained to avoid misinterpretation; job aids can also be provided to guide researchers’ decision-making in real time. The training can likewise walk researchers through not only the steps, but the timelines needed to complete patient visits and other key tasks.

Training, in this way, becomes a tool for proactive troubleshooting, reducing the need for after-the-fact procedures to address protocol deviations.

To learn more, visit our Pro-Active Protocol webpage: https://www.pro-ficiency.com/protocol-optimization/

Bringing Protocols to Life to Reduce Site and Patient Burdens

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In a world where clinical trials are growing larger and protocols more complex, it’s increasingly important that study sponsors make sure to get their protocols right from the start to avoid unwanted delays or cost overruns due to mistakes, deviations or even just failure to correctly forecast the time, money and resources needed to conduct a study. 

And that means that the art and practice of protocol optimization, utilizing input not only from target patient groups, but from potential site partners, as well, becomes ever-more important. 

Protocols are getting more complex for many reasons, such as regulatory demands, expansion into more challenging indications like rare disease and immunology, adaptive study designs and trying to get as much data from one study as possible. A 2021 study by the Tufts Center for the Study of Drug Development (CSDD) noted that protocols have been growing increasingly complex since 2009, with no end in sight to that trend. For instance, the CSDD report said that Phase II and III protocols as of 2020 generally had about 20 endpoints, with an average of 1.6 primary endpoints, up 27% since 2009. And the mean number of distinct procedures required for a typical protocol rose 44% during the same timeframe.

Amendments are also increasing. CSDD noted in an early 2022 report that the mean number of protocol deviations and substantial amendments—another cost and time driver—have increased across all clinical trial phases. The typical Phase 3 trial has 119 deviations, the CSDD report said. More amendments mean more operational burdens for sites, longer cycle times and more chances for deviations.

And about 30% of patients in Phase 2 and 3 studies have deviations; more deviations can lead to poorer quality data and outcomes. But many amendments, as well as deviations, can be avoided by better planning up front, especially in the face of more complex protocol designs.

 

Feasibility should be a conversation

Protocols typically are written to meet regulatory obligations, not to help research sites efficiently operationalize them. This leads to a disconnect when it comes to operational feasibility. At most, sites will check off a feasibility form that indicates whether they do or do not have particular equipment and access to desired patients.

But operational feasibility needs to be viewed as more of a process or a conversation, not just completion of a simple form. And protocol optimization is the means by which operational feasibility can be built into the study design from ground zero.

Protocol optimization can be viewed as an in-depth examination of the who, what, where, when, why and how of what it will take to conduct a successful clinical trial. In most cases, protocols do a good job of explaining what must happen when—in other words, detailing the procedures to be followed and the schedule. But questions often arise around the who and the how of protocol implementation.

The who is generally viewed as the target patient population. The protocol must define this group very clearly, explaining how the patients are characterized and defining specific inclusion and exclusion criteria.

Sponsors generally do a good job of defining the patient population they want to target with different clinical trials. However, the way they communicate this information in the protocol is rarely optimal. For example, most protocols include numerous inclusion and exclusion criteria, but provide them in a random order. Some may be copied from previous protocols or from a corporate template. But rarely are the criteria written with consideration of, for instance, how sites will go through potential patients’ medical records. 

A better approach would be to provide some sort of organization of the criteria that aligns well with normal site workflow. For instance, inclusion/exclusion criteria could be organized by body systems, medications used or time restrictions, among other categories.

This sort of enrollment optimization can make the protocol more easily understandable—and thus, easier to execute correctly—for both patients and research sites. And that means fewer enrollment issues and reduced chance of deviations related to patient recruitment, enrollment and informed consent.

 

A site-centric approach to better explain the ‘how’

The other area in which protocols tend to need optimization is in explaining exactly how, in sufficient detail, protocol activities are to happen. And this is an area where early input from target sites themselves can be invaluable.

Patient-centricity has become a buzzword within the clinical research industry, with sponsors, sites and even regulators emphasizing the importance of providing a positive patient experience to aid in recruitment and retention of study participants. This can include factors like schedule flexibility and use of decentralized features or technology to increase convenience for patients.

In order for that to happen, patient-centricity must be built into a protocol from its inception, using real-life input from patients and advocates about the real needs and preferences of the target population, as Mike Lang noted in a blog post on the Pro-ficiency website. And that means that protocols need to be optimized with an eye toward real-life patient needs and preferences, usually by getting input from patient groups during the protocol design stage.

But patient centricity can be difficult to achieve if sites are not fully capable of delivering an optimum experience. What is often missing is a site-centric approach to determining what is truly feasible, as well as what time, equipment and human resources are realistically needed for a protocol to be viable. In some ways, the emphasis on patient-centricity has led to less consideration of operational feedback from sites.

And in reality, one of the most patient-centric actions sponsors can take is taking a site-centric approach to optimizing their protocols. Sites interact with patients and are responsible for implementing protocols in a patient-centric way, so making the protocol more organizationally feasible for sites will ultimately add to patients’ experiences.

And this type of information can only come with early feedback from sites. If protocols are not absolutely clear on the ‘how’ of implementation, down to the smallest detail, that leaves sites with room for interpretation based on their individual capabilities, set-ups and standard practices. The end result? In essence, a study could have 200 sites around the world applying their own interpretations to protocols. This can lead to cost overruns due to under-estimating staff or equipment needs, or protocol deviations or mistakes due to unplanned glitches in operations.

For instance, protocols often use footnotes or separate operational manuals to provide precise instructions on how to carry out various activities. A protocol may state that sites need to take patients’ blood pressure at visits on a certain schedule. And sites may take this information to estimate the time needed for each visit, as well as estimating the associated person-hours that must be funded. But if a footnote or manual then mandates that the measurement be taken standing for a certain amount of time and sitting for a certain amount of time, this can throw off the estimated visit time needed and drive up time and costs.

Similarly, a protocol may mention pharmacokinetic sampling requirements at certain visits. But the supplemental information might stipulate widely different timing relative to the study drug dose at different visits.

Even facility layout can pose a challenge, if the pharmacy is supposed to prepare a sensitive treatment within a certain timeframe but the distance from the pharmacy to the clinic is too far to allow that timeline to be met.

This can be further complicated if there are errors or inconsistencies in any of the supporting documents or footnotes. And that issue is exacerbated by the need to maintain version control and accuracy of all these parts if one is updated.

 

Visualizations help bring the protocol to life for sites

But sponsors can work with sites to avoid many of these problems and prevent confusion that can lead to errors, deviations and delays. It comes down to operational feasibility. Factors that are most important to sites are those that involve what they must do, when they must do it and how they must do it.

It’s not enough for a site to check off that it has access to patients or certain equipment or facilities. These basic qualifications may not tell the whole story of how easy or difficult a protocol may be for a given site to implement. For instance, a site may have broad access to diabetes patients, but may not have many that meet all 70 inclusion criteria listed in a particular protocol.

Sponsors cannot provide this information to sites unless they look at the protocol through the lens of the staff that must implement it. And in order to do this, it’s important for sponsors to get complete and accurate evaluations from sites so that the protocol writers can incorporate that feedback into the finished protocol. Not all sites are structured the same, so some consideration may be required for variation among sites that they want to include in a study.

All parties must fully understand the study design and timeline so that they can see clearly how complex it will be in real life. It may be helpful for some sponsors to work with outside protocol optimization experts to ensure that they cover all their bases from the inception of each study protocol. Pro-ficiency’s proprietary optimization methodology, Pro-Active Protocol, can help achieve that goal by applying simulation to visually represent the operational flow of a clinical study.

For instance, visual mapping can be done to show, step-by-step, how drug preparation must be conducted, rather than forcing sites to figure out how to implement that part of the protocol without having to piece together information from multiple documents. Sites can then see clearly how those steps would work within their own organizational structures.

This ability to help sponsors and sites visualize the information contained in disparate documents is a key value of services like Pro-Active Protocol.

In this way, sponsors and sites can experience a “day in the life” of a planned study, looking at it from both a site organizational and patient experience view. This insight will prove invaluable. Not only will it allow sponsors to incorporate feedback from sites and patients into the protocol design, but the simulation can be used later to let sites and patients understand in mere minutes exactly what participation in a study will entail, including possible curve balls like patient relapse.

This can aid enrollment by letting patients understand viscerally how study participation will fit into their lives. And it can aid in site selection, preparation and training by giving sites a clear view of what study participation will demand of their organizational structures and procedures.

 

Get in touch to learn more: http://proficiency1.wpenginepowered.com/contact-us/

3 Steps for Reducing Costs and Errors in Clinical Trials

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Clinical trial costs are trending upward, driven by a variety of factors, such as increasing trial complexity and rising travel costs for training, meetings and monitoring. While some of these factors are largely fixed, costs can be controlled by focusing on areas that lie well within the sponsors’ and research sites’ control.

And much of that focus should be on things that can lead to errors, which can significantly increase the time needed to complete a clinical trial, require work to be re-done and require corrective actions, such as staff re-training, that also add to costs.

But three simple steps can help clinical researchers reduce both errors and costs during studies. The trick is to focus on those parts of clinical trial preparation and conduct that can most affect key drivers of cost increases.

Clinical trials are expensive. There is no way of getting around that fact. AMarch 2022 blog on the My Onsite Healthcare website estimated that the cost of bringing a new drug to market runs between $161 million and $2.6 billion. This can translate to an average cost of $41,000 per patient, according to a 2019 article in Clinical Leader.

Myriad factors go into the cost of a clinical trial. The costs to manufacture, transport and store the investigational product, for instance, are important and immutable. Staff salaries, travel costs and the cost of equipment and supplies can also play a role. But some factors have a greater impact than others.

Errors in enacting the protocol can add significantly to the cost of a clinical trial, primarily by adding time and person-hours, as well as requiring work to be repeated for errors egregious enough to threaten the validity of data gathered.

And protocol deviations or errors are common.  According to FDA data, protocol deviations remained the top BIMO inspection observation for 2021, as they have for the last several years.

The Tufts Center for the Study of Drug Development (CSDD) agreed, noting in >an early 2022 reportthat the mean number of protocol deviations and substantial amendments—another cost and time driver—have increased across all clinical trial phases. The typical Phase 3 trial has 119 deviations, the CSDD report said.

Amendments are particularly troublesome. The timeline for protocols with three or more substantial amendments tend to require nearly three more weeks of treatment for enrolled patients and see close-out delayed by nearly four weeks, the CSDD estimated.

 

Step 1: More complex trials call for clearly written protocols

Recent attention has focused on growing clinical trial complexity as a cost driver. More complex trials tend to take longer, which adds to the cost of a study. More complex protocols also tend to offer more opportunities for errors, which can add additional time and expense to correcting those errors.

A 2021 study by the Tufts Center for the Study of Drug Development (CSDD) noted that protocols have been growing increasingly complex since 2009, with no end in sight to that trend. For instance, the CSDD report said that Phase II and III protocols as of 2020 generally had about 20 endpoints, with an average of 1.6 primary endpoints, up 27% since 2009. And the mean number of distinct procedures required for a typical protocol rose 44% during the same timeframe.

So, the first step to cost control is to focus on the protocol, ensuring that it is written in a way that is clear and easy to understand, both across sites and across jobs at any given site. As noted above, the growing complexity of clinical trials has been tagged by experts as one of the top reasons for protocol deviations or errors to occur. Protocols that include many individual procedures, require novel procedures that differ from standard of care and/or have a larger number of endpoints can be particularly prone to errors.

Including site staff early in protocol development can help ensure that protocols are written in a way that is clear to all employees. For larger trials that involve global sites, consideration of how language and cultural differences may impact protocol adherence is also important. And site resources and expertise also need to be considered when developing a protocol; not all sites will have access to the same equipment and supplies or have the same levels of expertise in all areas.

 

Step 2: Training to ensure predictable performance

The next step then must be to provide thorough, effective training designed to ensure that all staff fully understand how to do their jobs in line with the protocol. And this can be challenging to achieve with a traditional lecture- or slide-based training session.

In 2019, Harvard indicated that slide-based training and education is not effective in imparting knowledge in a way that alters performance, calling the combination of slides and lecture “worse than useless.” This is important for clinical research applications because the entire purpose of training on a protocol is to ensure that behavior is changed for the better—“better” meaning accurately carrying out tasks as described in the protocol.

For example, failure to correctly apply inclusion and exclusion criteria during patient screening can lead to a mismatch in patients and the protocol. The end result of this is likely time and money spent collecting data that ultimately cannot be used as part of an application for new product approval.

Examples of the value of simulation can be found in other industries, such as aviation, where crashes are greatly reduced when pilots are trained via simulation. Similarly, within the healthcare industry, simulation training has been used to reduce anesthesia mishaps.

Protocol simulation training provides actual practice in critical study skills, including GCPs, pharmacokinetics, informed consent, placebo arms and investigational product handling, among others.

An important feature of simulation-based training is the ability to identify and focus on weak areas, while also predicting staff and site performance before a study even begins. Simulation training provided by Pro-ficiency, for example, includes a dashboard that highlights how staff within a site performs during training, as well as performance across multiple sites. Sponsors can quickly identify where protocol procedures have been mastered, where significant knowledge gaps exist and where some corrective guidance was needed during the training process.

This lets sponsors quickly and easily identify poor-performing sites and individuals, as well as narrowing down where weaknesses exist. This allows for additional, closely targeted training and support before the first patient is enrolled in a trial, which helps to avoid errors and associated costs during the study.

This type of feedback can also quickly identify any problem metrics showing that most people struggle with a particular task or procedure. This knowledge can be applied to improve the way the protocol is written, if necessary, further reducing costs by going back to ensuring the protocol is clear.

Equally important is the ability to identify “heroes” at individual sites, as well as “rock star” sites, that who perform exceptionally well.

 

Step 3: Decision support tools to aid long-term performance

The final step is closely linked to the training. It is not at all uncommon for training to occur well before sites begin enrolling patients. This lag in time between learning protocol procedures and having to apply them can lead to less reliable recall, which can cause errors and up costs.

Decision support tools can be developed alongside a simulation-based training program to provide site employees with references that they can use once a clinical trial is underway. For example, tools to aid research coordinators and investigators in patient screening could list inclusion and exclusion criteria; the availability of simple lists of this sort can help to reactivate the “muscle memory” generated with the simulations included in training.

Novel or complex procedures required for a given protocol could likewise be supported with checklists and/or illustrations. Decision support tools provided in an electronic format could even include brief animations that employees could reference to remind them of the correct way of completing the procedures. For instance, if a special sort of imaging is required for a study, a support tool could list key steps and identify ways in which the protocol’s imaging procedures differ from standard practice.

Decision support tools can be provided in hard copy form, such as checklists, flow charts or flash cards, or in electronic form that can be accessed with a tablet, phone or through a site’s computer system.

Errors and protocol deviations are among the top factors that add to a clinical trial’s time and costs. As with many problems, proactively identifying and addressing potential errors is more effective and cost-efficient than merely reacting after an error occurs. By focusing first on writing a clear and easily understandable protocol and second on providing effective training and related decision support tools to site staff, sponsors can help assure that they address potential errors up front and reduce the likelihood that deviations will increase the time and cost needed to complete their clinical trials.

 

To learn more regarding how to reduce clinical trial costs, visit our website: http://proficiency1.wpenginepowered.com/

Developing Protocols For Patient-Centricity

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Patient-centricity has become an increasingly important focus for clinical researchers in recent years. Creating a research experience that addresses patient-expressed needs and wants is an important part of recruiting and retaining sufficient numbers of qualified patients.

And it’s not enough to add a couple of features broadly considered to be what patients want, such as use of telehealth or home visits to reduce the number of site visits required for a study. The only sure way to ensure that sponsors can ensure their clinical trials are truly patient-centric is to design that focus into the protocol from the start, using a protocol optimization method such as Pro-ficiency’s Pro-Active Protocol solution.

In essence, patient-centricity marks a shift from the traditional disease-focused approach of conducting clinical trials to a philosophy that puts the well-being of patients enrolled in clinical studies first and treats them as “informed collaborators whose participation is crucial for the success of the research.”

Patient centricity has been at the forefront of the collective industry mind for the last several years. For instance, in 2016, the Drug Information Assn. (DIA) reported that a survey of pharma and biotech companies conducted in partnership with Tufts University showed that 65% of those firms had invested in patient-centric initiatives as part of their drug development programs.

By 2019, a SCOPE conference seemed to indicate widespread dedication to patient-centric trials, with representatives from various sponsors, CROs and other companies discussing how to incorporate more patient-centric aspects into research. 
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The FDA has also highlighted the importance of patient-centricity, as well, developing a series of four patient-focused drug development guidance documents to address various ways of collecting and using patient experience data to support clinical research:  

  • Patient-Focused Drug Development: Collecting Comprehensive and Representative Input, a final guidance issued in June 2020;
  • Patient-Focused Drug Development: Methods to Identify What Is Important to Patients, a final guidance issued in February 2022;
  • Patient-Focused Drug Development: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments, a draft guidance issued in June 2022; and
  • Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision-Making, a yet-to-be-issued draft guidance.

 

Why is patient-centricity important?

One of the driving forces behind the move to more patient-centric studies is concern over patient enrollment and retention. About 80% of clinical trials struggle with enrollment, and some studies estimate that up to 30% of patients drop out before a clinical trial concludes, according to a March 2022 Antidote blog. 

“When product-centric trials neglect patient needs, dropout rates are high and the integrity of the data becomes compromised,” the MD Group agreed in a 2020 blog. Conversely, patient-centric approaches to clinical trial design can result in higher patient recruitment and retention rates.

And speaking at the 2019 SCOPE conference, Beth Zaharoff, senior director for patient-focused engagement and partnership at TESARO noted at the conference that enhanced convenience for the patient and focus on unmet needs expressed by the target patient population can help boost enrollment and ensure that patients remain in the trial for its entirety.  Additionally, patient centricity can improve trial speed and efficiency by helping to ensure the protocol is simple to administer for the patient, she said.
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What constitutes a patient-centric approach to research? Schedule flexibility and use of decentralized features are factors that are often touted as means of making research participation more attractive to patients. Other options are also popular among sponsors, such as these steps recommended by the MD Group in its 2020 blog:

  • Make information accessible;
  • Involve patient associations;
  • Ensure that patients feel valued;
  • Reduce inconvenience wherever possible; and
  • Empower patients through technology.

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But the answer doesn’t lie in randomly selecting features with the label “patient-centric” and attaching them to all clinical trials. Speaking at the SCOPE conference, Melanie Goodman, Pfizer director of patient recruitment programs, emphasized that patient-centricity must permeate every aspect of a clinical trial, from the protocol to the site, to be effective.

In other words, patient-centricity must be built into the protocol from inception. And that means that protocols must be optimized with an eye toward real-life patient needs and preferences. Pro-ficiency’s proprietary optimization methodology, Pro-Active Protocol, launched last month, can help achieve this goal by applying simulation to visually represent the operational flow of a clinical study. The service aims to shed light on protocol inconsistencies and gaps so sponsors and researchers can adjust and revise before a study begins.

A critical part of the service is gaining patient insight—along with opinions from study teams and regulatory agencies—about how easy or difficult it would be for target patients to participate in a study.

The only way to make sure that the protocol is written in a way that is feasible for the target patient population is to get those patients involved in the early stages of study design. This can be done via workshops that involve researchers, patient advocates and the patients themselves, for instance.

Logistical issues that don’t even register with sponsors during protocol design can have a large impact on a study’s ability to recruit and retain participants. For example, patients with long-term or serious conditions that cause fatigue may lack energy to travel at certain times. And patients whose condition causes dexterity problems may struggle to operate some devices or open certain types of drug containers.

The Pro-Active Protocol solution can “help to visualize and animate the patient journey through the study,” Beth Harper, Pro-ficiency Chief Learning Officer, explained. “This helps to set expectations for how involved the study participant will be and to help potential patients understand their commitment prior to participation; they will see how long the study will be and how involved from a procedure and time perspective.”

Having this information available makes it easier for sponsors to get feedback from patients on how likely they would be to participate in a clinical trial, including potential barriers to participation and opportunities to further simplify the study design and schedule of events.

Pro-Active Protocol can serve as an invaluable resource, whether used as a stand-alone resource or integrated with Pro-ficiency’s existing simulation-based protocol modules to boost site and study team understanding of the protocol requirements upon start-up of the clinical trial.

 

Site feasibility also supported

But ensuring that the protocol is truly designed with the target patient group in mind is just one of two critical areas that loom large for protocol optimization efforts. The second, and equally important, key area is ensuring that the protocol is clear and understandable for the research sites that will be implementing it.

“The most patient-centric thing sponsors can do is to make the protocol easy, or easier, to implement,” Harper said. “The easier it is to implement, the less change of errors (deviations), both on the part of the sites and the patients.”

Aidan Gannon, Advarra director of client services and innovation, agreed in a 2021 blog that there is a close relationship between patient-centricity and site-centricity, as well.

“One could argue patient centricity is not possible without site centricity, as sites deliver the patient experience in clinical trials,” he wrote. “The best intentions of any sponsor or contract research organization (CRO) make little difference if sites fail to engage with participants.”

Sponsors should listen to site experiences and suggestions for improvements, as these often have very practical implications to how well a clinical trial is conducted, he suggested. Sponsors should also offer process improvements and other support to help address any challenges that sites report. 

These types of improvements can help sites run clinical trials more smoothly, efficiently and accurately. When not struggling with study-specific challenges, sites can turn more time, attention and resources to ensuring a patient-centric experience.

For example, Advarra noted one large pharma sponsor conducted a Phase 3 breast cancer study involving a short timeline and small patient population in 16 countries. The company provided custom training, engagement options and guided visits, among other things, which reduced screen failures by 50% and protocol deviations by 21%.

The better sites understand the protocol, the more confidence they will have in explaining it to patients, Harper said. In this way, clarity for sites ties back into patient needs, by providing sites with the intimate knowledge about how a protocol will really work so that their staff can communicate that information clearly to patients.

With this growing focus on improved patient-centricity, it is critical that sponsors provide protocols that address real-world patient needs, constraints and priorities. And they must make sure that the research sites they select to carry out their studies both understand and are able to implement the protocols in the most patient-focused way possible.

But many sponsors lack the tools in-house to develop the necessary insight to implement these types of changes to their protocol development process. This is where resources like Pro-Active Protocol come in. By pairing industry expertise with effective simulation techniques, this product can help sponsors ensure deep understanding of patient needs that can be incorporated into their protocols and communicated with crystal clarity to sites. The end result: well-written protocols that account for real-world patient experiences and are easy to implement correctly.

 

Click here to learn more about our Pro-Active Protocol solution: http://proficiency1.wpenginepowered.com/pro-active-protocol/

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