Want to see fewer protocol deviations and agile change management in your clinical trials while also reducing burdens on research site staff? Training—the right kind of training—can provide the solution to all three problems at once.
The right kind of training can be the key to solving three of the top quality problems faced by clinical trials:
- Adherence to the protocol, or protocol deviations;
- Management of changes to both the protocol and teams conducting the trial; and
- Responsibilities outside study conduct, including completing training that can be burdensome to site staff.
It is commonplace for protocol deviation occurrences to be accounted for as part of clinical trial budgeting. In fact, failure to adhere to the protocol is consistently the top finding during FDA bioresearch monitoring (BIMO) inspections, according to the latest metrics from the agency, covering its fiscal year 2022 inspections. [https://www.fda.gov/media/165853/download]. From inappropriate application of the inclusion/exclusion criteria and informed consent procedures to incorrectly dispensing of the investigational product. There are many areas of potential risk in protocol execution that can lead to even minor missteps resulting in potentially significant audit findings and potential Form 483 action from the FDA to your studies clinical sites.
The above examples are the most frequent BIMO inspectional observation for the last several years, topping the list in the FDA’s annual inspection metrics report since at least 2015, according to data on the FDA website. [https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/bimo-inspection-metrics]
Protocol specific training is part of the regulatory requirements placed on clinical research. The modality of that training can be a key determinant in how well that clinical trial is performed by the clinical sites as per the approved protocol. The point of training should be to mimic/simulate the situations and assessment that will occur in the real-time application of the protocol. If clinical site staff can reliably perform all the tasks beforehand, mistakes are much less likely when real patients are involved.
The best type of training for high-risk areas like clinical trials, where patient safety is on the line, should allow learners to practice. In CPR training, for instance, people practice skills on a dummy. For clinical research, simulation-based training lets site staff focus on key decision points in realistic scenarios that mirror what staff will face performing their roles during the clinical trial.
When learners make decisions within a simulation-based learning platform, the analytics and metrics produced from conduct of the training allow for immediate feedback on key knowledge gaps and high risk areas of execution of key protocol tasks. Within the platform, if the learner makes an incorrect decision, they are provided with an immediate corrective intervention. The learner is told why their decision or action was incorrect which instigates a link to what the protocol said, allowing them to make the correct decision, before proceeding to a a new scenario.
In this way, simulation-based training lets research staff perfect their skills before patients are enrolled and real data is being collected. By practicing protocol adherence and correct decision-making in a consequence-free environment, investigators, sub-investigators, clinical research coordinators, pharmacists and associated site and study team members gain experience similar to real life, making them less likely to deviate from the protocol after the trial begins.
Beyond that, Pro-ficiency’s customizable dashboards record when an individual needs multiple corrective interventions in decision-making for the program. This allows the sponsors to get metrics and data on both individual and site performance before sites are initiated to conduct the trial. This ensures that the metrics gained by this process can better inform a more accurate and representative risk-based monitoring approach, proactively. This focus on identifying weak areas reduces the risk of errors being made when patients are being screened/enrolled.
Pro-ficiency’s customizable dashboard and metrics can also identify role-based, site-based, geography-based or study task-based areas/risks before a study commences. This allows for a morea more focused site initiation/investigator meeting which is targeted towards risk mitigation discussions to ensure successful trial execution. For instance, the initial verbiage in the protocol or study manual may be unclear or the protocol may call for a procedure that differs significantly from standard of care, requiring extra guidance to overcome long-entrenched habits.
The metrics produced through completion of these simulated protocol modules allow study sponsors to dig down to the root cause of why research staff are struggling with key decisions. This ensures that all site and study staff fully understand the content and take the necessary steps to ensure high quality administration of the protocol. This may lead to ensuring study documents have better instructional content or improving the messaging and discussions investigator meetings to mitigate risk before they become an issue during a live trial.
Another significant quality challenge facing clinical research lies in change management. Changes to the protocol and to the team conducting a trial are regular occurrences. In a 2023 Impact Report, Tufts Center for the Study of Drug Development (CSDD) noted that the prevalence of protocol amendments has been increasing for several years, with more than 75% of clinical trial protocols requiring at least one substantial amendment. [(https://9468915.fs1.hubspotusercontent-na1.net/hubfs/9468915/Mar-April%202023%20-%20Protocol%20Amendments_Page_1.jpg] The most common areas modified are study assessments and study designs, according to CSDD.
Adaptive training mechanisms, like those available with Pro-ficiency’s simulation modules, really come to the fore when it comes to change management. With a simulation-based approached, the training can clearly highlight changes exactly as they affect specific tasks and procedures.
Additionally, by providing modules directly addressing the change, this type of training means research staff need only go through new training modules on the protocol changes, rather than repeating the entire training with the changes included. As with the initial training, when staff have proven competency in making the correct decisions under the change, they may progress; and where they may need additional corrective intervention, that is immediately available.
This approach reliably ensures that staff are able to perform changed procedures. Staff are not faced with sorting through new and old versions of the protocol or other documents. Rather, they are presented with only the changed material and given the opportunity to practice applying the modified protocol virtually before being expected to correctly perform the change with patients.
Clinical trials can also face changes when new team members join or depart a site or sponsor. A simulation-based approach to training such as that offered by Pro-ficiency can also help new team members get up to speed smoothly on new protocol procedures, while allowing them to quickly progress in training where they already demonstrate proficiency.
And this time savings relates to a third major quality issue faced by clinical researchers. Sites often complain about the workload faced by staff, with extra time spent on training among the top areas mentioned. In particular, re-training in areas where a staff member already is competent may be seen as a time waster. This is a problem both in initial training and with training due to changes.
An adaptive program like Pro-ficiency’s highlights key areas different staffers need to know for their roles in the conduct of the trial. The time to complete training is reduced by the focusing on the key decision areas for protocol execution.
The design of the training—short, sharp videos and case studies that instigate decision-making within a minute of being presented—also helps to better engage site staff and hold their attention for increased absorption of knowledge. When a learner shows competency by making the correct decision, that is acknowledged, creating a trigger in their head that this is the correct action for future application. They immediately progress to the next short, sharp video, with each able to work at their own pace.
In the event of a change—to the protocol or in staff, for instance—the platform is readily adaptable to those changes and therefore more efficient. When things change, any amendments or other changes can be re-edited without any consequences to other training content.
By providing true-to-life learning opportunities, instant feedback to learners and real-time metrics for sponsors to track training performance by individual and by site, Pro-ficiency’s simulation-based training platform can play a key role in tackling some of the top quality issues facing the clinical research industry.
Click here to learn more about our simulation training solution: https://www.simulations-plus.com/services/experiential-simulation/