Shorter training is an ever-present item near the top of nearly all clinical research site wish lists. The time and energy needed for training is among the many drains that researchers complain about, and the one that clinical trial sponsors have the greatest control over.
The growing complexity of clinical trials and the accompanying increase in researcher responsibilities has yielded a series of pain points for research sites. For instance, in August 2020, CenterWatch reported that sites were feeling overwhelmed by growing administrative responsibilities, among which training is often included.
The good news is that training is an area in which sponsors could work to limit the time burdens they place on sites. And they can do this simply by rethinking the traditional model of protocol training, looking instead at a more modern approach that embraces current learning theory, engages researchers and maintains a tight focus on the needs of each specific protocol.
When it comes to protocol training, the biggest downside to the traditional approach is that sponsors are trying to dump a massive amount of information—often in slide decks that could number up to 300—on the researchers, rather than engaging them and clarifying what is most important for a particular study. With too much information to digest, researchers cannot sort out the most critical from the less important and may struggle to remember everything they need to. This ultimately can lead to protocol deviations that could cause delays and increase the costs of a study.
Another major weakness of this approach is that it does not engage investigators and other research staff and it does not prioritize the information that is most important to successful conduct of the clinical trial.
The problem is that sponsors developing training often lack understanding of what information is critical, leading to failure to prioritize the information that will have the highest impact. This could include areas where deviations are more likely or where the consequences to the study or patient care would be the most serious in the event of a deviation.
So, sponsors need to consider whether the training they provide is focused enough on the specifics of the protocol. An approach that emphasizes protocol-specific skills and knowledge while identifying areas of poorer performance can ensure that those that need extra help get it, while not forcing more proficient staff to sit through unnecessary training. And that would mean that no researcher needs to spend excessive amounts of time on training.
The simulation format is really the solution to all of these problems. Simulation-based training like that offered by Pro-ficiency helps put researchers in hypothetical situations that mirror those they will face during the study itself. They are then able to practice making critical decisions that comply with the protocol. Any mistakes made are corrected with immediate feedback, allowing learners to improve their performance in a consequence-free environment.
And, most importantly to researchers undergoing the training, this approach allows them to progress at their own speed. If some individuals are very proficient in all of the protocol procedures, for instance, they may need to devote a relatively short amount of time—as little as 20 minutes, in some cases—to training. And even for those who need more time to fully master some of the procedures, the time needed for simulation training that is tightly protocol-focused is much less than the typical two to three hours required for lecture-based training.
And future developments in Pro-ficiency’s training will further enhance these capabilities. For instance, adding expertise in game theory can make the training even more engaging by allowing a “choose your own adventure” approach to training.
Pro-ficiency’s simulation-based training also provides analytics that can flag areas that multiple researchers may have difficulty with. In such cases, the sponsor can take action, such as providing additional targeted learning or focus on that issue during monitoring. Further, if particular individuals perform exceptionally well in some areas, those employees can be used as “site champions” to help other staff.
The end result: A clearer understanding of the protocol and greatly reduced chance of deviations and happy sites that don’t feel that training is robbing them of valuable time.
Catherine is one part executive, one part science/tech nerd, and one part starry eyed dreamer. In her role, Catherine leads the development of new solutions and enhancement of products so that Pro-ficiency can continue to delight customers and stay ahead of the curve. Catherine started her career as an analytical chemist doing process development for Bayer, where she developed the foundation for finding smarter ways to work. She transitioned into project management at IQVIA, and over the years became more focused on developing new tech solutions. Catherine has gained experience in several domains, spanning from drug development, medical informatics, and AI.