Clinical Research – Pro-ficiency

Tag Archive for: Clinical Research

The Power of Adaptive Learning

November 21, 2023/in Blog/by David Hadden

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

David Hadden

Dave Hadden is an entrepreneur and technology innovator, founding Pro-ficiency and pioneering the fields of A.I.-based medical decision-support, Training Analytics, and Virtual Patient Simulation (VPS). Dave has focused his passion for technological innovation and learning systems in the field of clinical trials, helping sponsors make their studies more accurate and efficient through finding the right technology mix such as virtualization, performance management and applied behavioral sciences to produce the most effective, lasting, and engaging results for clinical trials.

Unlocking Clinical Site Efficiency with Simulation-based Solutions

June 9, 2023/in Blog/by Rajat Mayur

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.

Rajat Mayur

Rajat is a dynamic leader with 15+ years of demonstrated success in leading commercial functions and driving transformation, growth, and profitability in product and service-based organizations across the life sciences sector. He started his career off as a sales specialist at Becton, Dickinson and Company (BD), offering his sales expertise to their advisory board while independently expanding their territory. He later moved to IQVIA, beginning as an Associate Director in Competitive Intelligence & Response and ending as the Head of JAPAC’s Commercial Operations through his ingenuity, problem-solving, and leadership skills.

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

May 18, 2023/91 Comments/in Blog/by Jenna Rouse

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.

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

Jenna Rouse

As Chief Experience Officer at Pro-ficiency, Jenna helps clients realize the full potential of their partnership with Pro-ficiency. Jenna has spent 16 years at the Association of Clinical Research Professionals (ACRP), including serving in various roles such as Business Development leader. Throughout her time at ACRP she helped hundreds of companies integrate competency-based learning, hosted by Pro-ficiency, into their workforce initiatives. In this work, Jenna began noticing her clients’ appreciation for the incredible Pro-ficiency platform, simulations, and customer service. Now, Jenna helps clients (including ACRP) realize the full potential of their partnership with Pro-ficiency.

Measuring Training ROI in Clinical Research

May 3, 2023/17 Comments/in Blog/by David Hadden

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/

David Hadden

Preemptive Protocol Analysis: Reducing the Need for Retraining

March 8, 2023/90 Comments/in Blog/by Beth Harper

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/

Beth Harper

Beth Harper, Chief Learning Officer at Pro-ficiency, is on a mission to eliminate protocol deviations. Beth brings 35-plus years of experience in clinical research operations to Pro-ficiency, utilizing this knowledge along with her years of creating live protocol simulation training to create cutting-edge simulation training programs at Pro-ficiency. Beth has published and presented extensively in the areas of study feasibility, site selection, patient recruitment, protocol optimization, sponsor/site relationship management and clinical research professional competencies. Beth received her B. S. in Occupational Therapy from the University of Wisconsin and an M.B.A. from the University of Texas.