M-04: Exploring and Addressing Gaps in GCP Training: Practical Approaches to Monitoring
University of Southern California United States
This study was conducted to identify the gaps that exist in the training of clinical trial professionals working in academia and to develop a training initiative that specifically addresses areas that are currently lacking, including tactical approaches to clinical trial monitoring.
ORAL PRESENTATION: 10:30AM
Striving for a systematic approach to our training initiative, we applied an implementation science framework to its development and launch. This study focused on the exploration phase and examined GCP training landscape through review of literature and survey of clinical research professionals.
A narrative literature review reinforced our initial supposition that available good clinical practice (GCP) trainings are too broad in scope and lack the practical approaches to meet the complex requirements of monitoring. For those in academia looking to learn how to conduct trial monitoring, many training programs require fees or institutional affiliations and, hence, are difficult to access for most researchers working on investigator-initiated trials. Our survey results also show a deficiency in monitoring of investigator-initiated trials and a lack of effective training for research professionals in the area of quality control and quality assurance. In a survey conducted in the fall of 2017, only 62% of 60 research professionals from the Southern California region reported that their investigator-initiated trials were monitored. In practice, this number may be even lower due to a lack of understanding about clinical trial monitoring and research professional bias. When we administered a small quiz on basic monitoring concepts to 84 research professionals in the fall of 2017, we found that the average quiz score was only 29%. Although surveyed research professionals have had extensive work experience as clinical research coordinators, project managers, and data managers, their quiz scores demonstrated that many of them do not understand quality elements including basic monitoring concepts, such as source documentation, monitoring reports, and monitoring plans. Additional assessments revealed that 94% of 80 respondents believed that academic institutions would benefit from pools of monitors that could monitor investigator-initiated trials and 89% of 76 respondents believed that they would need additional training beyond currently available GCP training in order to serve as a clinical trial monitors.
In order to ensure data integrity and human subject protection in clinical trials, monitors provide essential unbiased quality control functions through continual data reviews during the trial. Unlike clinical trials sponsored by the pharmaceutical industry, where companies provide study monitors to verify research quality, studies conducted in academia often lack proper oversight to ensure research quality. Without thorough knowledge of monitoring processes by research personnel, the rights and safety of the clinical trial participants, data quality, and overall conduct of clinical trials may be compromised. From our findings, it is evident that neither academic research work experience nor current GCP training effectively teach basic monitoring concepts to even the most experienced research professionals. Consequently, the development and successful implementation of a monitoring training initiative may be crucial in providing investigators and institutions with the tools to ensure quality in their clinical trials. This clinical research quality training initiative aims to cross-train academic research coordinators in clinical trial monitoring, producing pools of research coordinators who could serve as monitors at academic institutions and monitor studies that they are not directly coordinating. Moving forward, we will continue to follow the implementation science framework by engaging stakeholders, developing metrics to study the effectiveness of the intervention, and continue to update the training initiative based on feedback and updates to the GCP guidelines. By educating the research personnel on monitoring processes, we can help to ensure the integrity of their research and expedite the translation of discoveries to important therapies.