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Building Patient Trust with Next-Generation Clinical Trial Training

Patient trust is critical to ensuring adequate enrollment and retention of clinical trial participants. If patients lack trust in the capabilities of the investigators, nurses and other staff conducting a clinical trial, they are less likely to enroll in a study, and even if they do, they are more likely to drop out if their trust is rocked at any point by shaky performance of trial procedures.

The way that clinical researchers are trained can play a key role in building the necessary trust. The more confidence patients have in the knowledge and abilities of research staff, the more comfortable they are likely to be with the trial processes—and the more likely they are to enroll and remain in the trial for the duration.

Simulation-based training, such as that provided by Pro-ficiency, can play a crucial role in increasing patient comfort levels with clinical trial participation. By offering realistic scenarios, this type of training lets clinical research professionals hone their skills in a risk-free environment. This immersive approach based on realistic scenarios bolsters their qualification and competence, so researchers are better equipped to conduct trial procedures smoothly and effectively, leading to a more comfortable experience for patients.

Most trial participants are unaware of how sponsors conduct training on protocols or that the traditional approach relies on slide decks, a method that most patients would likely view as worrying. Additionally, the pharma industry in general faces challenges related to mistrust. In clinical research, any uncertainty displayed in describing or performing protocol procedures can exacerbate any reservations a potential study participant may feel. And this can drive both low enrollment and participant drop-out after a study begins.

Patients want to be confident that the investigator or research nurse is providing the right dose on the right day, for instance, and that the team has all the tools necessary to execute the trial correctly.  That puts a burden on research teams to demonstrate to patients that they have sufficient knowledge, skill and understanding to overcome that underlying suspicion—a burden that is difficult to overcome without thorough training.

A 2021 blog post from Medidata emphasizes the foundation of trust in clinical trials. It highlights the needs for clear communication to ensure that participants comprehend study procedures early in the process. This then sets the stage for more impactful communications throughout the trial, which further fosters trust between the patient and the research team.

Medidata writes, “To build trust with clinical trial participants, it’s important they understand precisely what is being done and why, early in the process. With that established, the communications that follow will have more impact and help establish trust throughout the trial experience.“

And sometimes, a simple solution is the most effective. In this case, innovative training that successfully alters the behavior of healthcare providers conducting clinical trials and improves performance of all clinical trial procedures can play a key role in building and retaining patient confidence and trust.

Training that ensures competence in all trial procedures can play a major role in presenting trial information in a way that assures patients and their families that participation will be a positive experience.

Proven Performance Results

Simulation training, such as that provided by Pro-ficiency, provides research teams with the chance to practice. Immediate feedback helps to guide research staff to develop better decision-making skills. The intuitive dashboard allows tracking of performance within and across sites.

This training approach immerses coordinators, investigators and other research staff in realistic scenarios, which helps to ensure that they are well-prepared to both describe and perform procedures accurately, giving participants more confidence in a trial. By providing a risk-free environment to practice and gain skill and understanding, a simulation-based training platform enables research staff to confidently interact with patients, conveying accurate information and addressing any concerns they may have. This ensures that patients receive clear and consistent communication throughout their participation in the trial, enhancing their overall experience and likelihood of enrollment. 

Real-time performance analytics of sites allows sponsors to see where gaps or weak areas may exist and to focus on the areas where training is most needed.

This type of training has proven over time to be extremely effective in improving performance. For instance, Elio Mazzone et al. noted in a paper in the August 2021 Annals of Surgery that proficiency-based progression simulation training was more effective than traditional training in reducing procedural errors and increasing the number of correct steps taken. A key, the paper said, lies in continuous feedback and the ability to repeat tasks until they are done correctly.

Why? Virtual simulations of realistic, protocol-specific scenarios provide the opportunity to replicate real-world situations, providing an environment that invites engagement and builds accessible professional knowledge, rather than providing just abstract learning of content from static materials. At its heart, simulation technology achieves a complex, meaningful interactivity, allowing users to construct and test hypotheses and receive feedback in response to their actions in a risk-free, persistent environment. Learners can actively and rigorously develop needed skills by facing simulated challenges, seen in David Hadden’s previous protocol deviation article.

And the proof is in the pudding. In 2010, an analysis was conducted of data from a country-wide deployment in East Africa for the CDC. Every healthcare professional in the country was trained on a rigorous HIV treatment protocol

One past webinar, Imagine a world without Protocol Deviations’, illustrated the results of that training. A green circle represents a clinician who executed a simulated patient encounter with an acceptable level of clinical variance. The graphic on the left shows a pass rate of 69%. The graphic on the right shows that the pass rate increased to 97% after simulation training.


These factors become especially important for larger, international studies. With more research sites involved, there can be greater variation among capabilities, which can lead to protocol deviations. And when international sites are involved, complications related to language and culture can challenge research sponsors to provide training that meets all the different needs at myriad sites.

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. Pro-ficiency’s dashboard of training metrics can provide just such an outline, making it easy to highlight where language or cultural barriers may exist and allowing agile development of custom modules to address those challenges. This proactive methodology has been discussed here previously.

Another benefit of simulation is that the knowledge gained tends to stick with learners better than lecture-based methods. The ability to practice tasks and procedures virtually in a risk-free environment allows employees to develop accurate muscle memory that helps them perform optimally in real-world situations.

This is especially important when it comes to developing skill and proficiency in procedures that differ from the standard of care. The ability to smoothly perform and explain novel techniques or procedures to patients is critical to ensuring patients are comfortable with trial participation.

Pro-ficiency’s platform, for instance, reduces the likelihood of errors or complications during a trial that involves novel treatments by immersing learners in lifelike scenarios. Knowing that the healthcare providers treating them during a clinical trial are well-qualified and competent in protocol-specific procedures goes a long way toward instilling trust and reassurance in patients.

Proactive problem-solving

Simulation training also allows for proactive addressing of problems in a consequence-free environment before a trial even begins. When problems are only addressed after they occur in a live clinical trial, patient trust can erode. Identifying and addressing issues up front, on the other hand, can boost patient trust in the trial and the team implementing it.

A lot of distrust in the pharma industry and in the clinical trials it sponsors can be linked to the industry’s tendency to address problems only after they occur.

But Pro-ficiency’s training packages, for instance, include analytics that are just as important as the training itself. This information can help managers track not only progress in completing the protocol-specific training, but also provide invaluable information about how well individuals and sites perform as they move through the training.

The immediate feedback and analytics offer extra support and guidance to individuals or sites struggling with any aspect of the protocol. This real-time assessment allows for timely intervention and remediation, ensuring that research staff are adequately prepared to conduct the trial procedures and interact with patients effectively. By addressing areas of difficulty promptly, Pro-ficiency contributes to the overall success of the trial and improves patient satisfaction and retention. 

In other words, if staff can complete the simulated activities successfully, the training itself proves their competency. For instance, if 70% of a cohort failed in the first attempt at a simulated procedure, the organization would know that was a problem area in the protocol that needed to be addressed. 

The design of the training modules allows high achievers to move easily through the material at which they already excel, while learning new procedures or practices at a suitable rate. Meanwhile, those with less knowledge or experience are carefully guided to making the correct decisions.

Investigator meetings can then be used to address any remaining pain points, using the performance analytics to guide those conversations. This will help ensure that training remains focused on crucial issues without wasting investigators’ time.

This level of training helps to ensure that investigators, coordinators, research nurses and other staff thoroughly understand the study and its procedures before they speak with patients. Not only does this help them execute the study without error, it also gives them the in-depth understanding necessary to confidently explain a trial to potential enrollees and to answer their questions easily and correctly.

With this deep understanding, research teams can focus on building relationships with patients, rather than on remembering details of the clinical trial protocol.

In conclusion, the pivotal question emerges: If patients were aware of how their HCPs were trained for trials, would they still enroll? Transparency about site performance, completion reports, and the success of top sites could potentially influence patient enrollment decisions. These considerations prompt a reevaluation of our current practices, urging us to embrace transformative approaches to clinical trial training for the benefit of all stakeholders.

Simulation-based training has a well-documented track record of producing competence among healthcare professionals. Pro-ficiency’s platform leverages this proven effectiveness, providing research staff with the skills and confidence necessary to conduct clinical trials successfully. By offering realistic simulations and comprehensive training modules, Pro-ficiency equips research staff with the tools they need to navigate protocol procedures and patient interactions with proficiency and professionalism.

The Power of Gamification in Clinical Trial Training

Gamification has become a buzzword in recent years, taking center stage in various industries such as education. But it’s often misunderstood and underutilized. Simply put, it’s making processes more game-like to engage users better. The video game industry, boasting titles like Candy Crush, knows the key to player engagement lies in those rewarding little endorphin rushes. However, gamification is not just about points and bright flashes. It is also about understanding what drives users to engage with content. When we bring this concept to the realm of clinical trial training, the results are fascinating, especially with Pro-ficiency’s unique approach.

At first glance, gamification and clinical trials seem worlds apart. Yet, they share common ground when simulations come into play. Unlike the repetitive matching of colored squares in Candy Crush, clinical trial simulations empower site teams, investigators, and doctors to take an active role in decision-making, altering the game’s results.

Why Simulations Work for Clinical Trial Training

The benefits that gamification, specifically simulation training, have for clinical trial site teams is immense, and Pro-ficiency has tapped into this approach’s immense potential.

  1. Conscious Choices with Real Outcomes: Unlike typical games where the aim is to score points, Pro-ficiency’s simulations immerse users in scenarios where their decisions lead to actual outcomes. This hands-on approach, paired with real-time feedback, ensures that users remain actively engaged.
  2. Engaging Multimedia Content: Traditionally tedious subjects come alive through captivating videos, interactive graphics, and audio clips. This not only grabs attention but also enhances information retention.
  3. First-person Immersion: Some of Pro-ficiency’s simulations are presented from a first-person viewpoint, which puts users into patient interactions, making the learning process more personal and relatable.
  4. Self-Guided Exploration: One size doesn’t fit all. Recognizing this, Pro-ficiency allows users to explore at their own pace, fostering a deeper understanding of the subject matter.
  5. A Stress-Free Learning Environment: The fear of making mistakes can hamper the learning process. Pro-ficiency’s simulations turn mistakes into valuable teaching moments, creating an environment conducive to growth.
  6. Meaningful Performance Metrics: Pro-ficiency “grades” and “ranks” users compared to their peers, fostering a sense of healthy competition and camaraderie.

Gamification has been used in education for years with obvious benefits. A 2019 study from the Journal for Nurses in Professional Development found that gamification had a positive effect on the orientees’ motivation and knowledge retention. Another 2014 study from the Postgraduate Medical Journal found statistically significant increases in knowledge retention over time using gamification with graduate students. 

Traditional static training struggles to impart the same benefits. Users often struggle with retention and engagement when material is presented statically. Simulations enable clinicians to gain a deep-seated knowledge of their work, protocols, and patients. They also provide a safe haven to make and learn from mistakes before they become a larger issue in the real world.

Click here to learn more about Pro-ficiency’s use of gamification in our simulation-based methodologies.

The Power of Adaptive Learning

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 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:

Unlocking Clinical Site Efficiency with Simulation-based Solutions

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

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:

Measuring Training ROI in Clinical Research

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.

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