Elevate Training to Overcome Site Burden and Reduce Protocol Deviations by 35-50%

Much of the clinical trial landscape has changed significantly over the past decade, giving rise to a new normal in which investigators are faced with greater responsibilities and higher risks. In fact, 70% of site staff believe conducting trials has become more difficult over the past five years.¹ A large-scale analysis of data from more than 16,000 clinical trials assessed key features of the trials over different clinical phases, such as protocols, technology, sample collections, participant monitoring, and drug administration. The findings indicate trials have in fact become more complex, “across all phases and most therapy areas.”²

As trials evolve, the industry’s approach to training people to conduct them has remained unchanged—and this is a serious problem. Outdated training leaves sites unprepared, posing increased risks to participants and the trial’s outcomes. A study published in Neurotherapeutics cautioned, “As protocols increase in complexity, there is the potential for an increase in deviations from the institutional review board (IRB)-approved protocol, which is common in research.”³  In fact, 30% of all FDA inspection warning letters are sent due to the failure to follow the investigational plan.⁴

Given these risks, training must be prioritized and should be recognized as a pivotal element that can directly influence the success of a clinical trial.

Investigators Opting Out

The Neurotherapeutics study raised concerns about the state of investigator training. Pointing to the absence of formal training in conducting human subjects research both in medical school and residency, the authors wrote, “This lack of training and ‘learn as you go’ approach can compromise the integrity of the study, expose patients to harm, and increase the vulnerability of the researchers with the possibility of disciplinary action from regulatory bodies.”

Many investigators find managing clinical trials to be too difficult, too risky, or both. An article published in Frontiers in Medicine last year points to a study of the U.S. FDA’s Bioresearch Monitoring Information System; there was an increase in investigators involved in only one clinical trial—referred to as “one and done” investigators. The authors state this decline signals “potential adverse trends in the clinical investigator workforce,” with about 40% of unique investigators annually deciding not to participate in another FDA-regulated trial.⁵ Not surprisingly, there has also been a 20% decline in site satisfaction ratings related to trial training since 2019.⁶

The industry needs to improve its training methods to provide investigators with the motivation and confidence to conduct trials, as well as ensure safety and compliance throughout.

Recommendations for Improving Clinical Trial Training

Across many industries, including areas of life sciences, training methods have evolved in keeping with technological advancements and best practices in continuing education. Deploying these innovative technologies and practices can elevate investigator training to meet today’s needs. Among the methods that make the best use of investigators’ time and faculty’s expertise are training programs that allow for both self-directed (on-demand) learning and engaging, expert-facilitated live sessions.

In its Investigator Qualification Project, the Clinical Trials Transformation Initiative (CTTI) identified “gaps and redundancies” in current investigator training methods and provided recommendations. CTTI found that “the industry standard ‘one-size-fits-all’” training was not likely to sufficiently prepare investigators.  It had the potential to be both too little for inexperienced site team members and too redundant for experienced teams. They also noted that both investigators and sponsors found current training to be “burdensome and repetitive.”⁷

The combination of on-demand and live training addresses these concerns. Enabling individuals to work at their own pace on materials that introduce elements of the trial allows them to personalize their learning, with the first step being choosing a convenient and undistracted time to log in. On-demand platforms make additional resources available for those who need them, while the more experienced investigators can move more swiftly through this phase. Features such as moderated discussions and mechanisms for asking questions further enable site teams to learn from each other and the faculty. Presenters of the live training sessions can then use engagement and knowledge data from this preparatory phase to develop live training.

Among CTTI’s recommendations for improving investigator training was that it be more engaging and interactive, and focused on the study team rather than an individual investigator. Engagement has been found to be among the most effective ways to ensure learners pay attention to and understand content. Investigator meetings with higher engagement see a 19% increase in knowledge transfer.⁸ The traditional didactic, lecture-style life sciences training is outdated in the face of technology that puts content in investigators’ hands and enables them to answer polling questions, annotate and save slides, ask questions at will, and even take part in friendly competition as they demonstrate their knowledge.

Since today’s technology collects real-time data from learners, insights can be viewed across individuals as well as across site teams, as CTTI suggests. It is easier than ever to visualize who gained the most knowledge throughout a training program, where there are gaps, and what factors may have affected those results (such as participation in the on-demand portion of training or levels of engagement). Sponsors can focus additional, tailored training to ensure all sites are prepared to enroll participants.

Improved Study Outcomes

The methods and technologies exist to elevate training to be more engaging and effective. Changing the paradigm around training and deploying these resources can significantly impact the willingness of investigators to take part in clinical trials, as well as the outcomes of those trials. Continuing to view training as a required, but not essential, step in the clinical trial process squanders the opportunity to improve key metrics around the clinical trial timeline, quality of study data, and adherence to the approved protocol.

References:

1. Tufts Center for Drug Development, Jan/Feb 2023.
2. Clinical trials are becoming more complex: a machine learning analysis of data from over 16,000 trials
3. Reducing Events of Noncompliance in Neurology Human Subjects Research: the Effect of Human Subjects Research Protection Training and Site Initiation Visits
4. Quantifying Protocol Deviation Experience by Clinical Phase
5. https://pmc.ncbi.nlm.nih.gov/articles/PMC6536616/
6. WCG CenterWatch 2025 Global Site Relationship Survey.
7. Improving the quality conduct and efficiency of clinical trials with training: Recommendations for preparedness and qualification of investigators and delegates
8. Array data analysis of all meetings supported in 2024.