University of Southern California (USC) researchers identified the challenge that often investigator-initiated trials (IITs) don’t have the same trial monitoring coverage as industry trials and addressed this gap by developing a self-study module that can be used to cross-train academic researchers in essential concepts and practical approaches to monitoring.
Investigator initiated trials are instrumental in translating academic research into medical product development. The USC team reports that only about 65% of IITs reported as being monitored—that leaves 35% of all IITs as not monitored—that represents a substantial volume of unmonitored research!
According to a CenterWatch report the number of IITs approached nearly 2,000 by 2002 and declined significant only to start increasing again to 615 by 2014. 836 Research (non-industry) INDs were received by the FDA in 2017. Of interest, ACRP produced a survey of current IITs practices in 2016.
Observed deficiencies in the quality control of these clinical trials can potentially lead to inadequacies in data accuracy and validity that could lead to significant delays in bringing innovative therapies to patients.
Recent NIH policies require data and safety monitoring for all of the trials it supports. Moreover, the latest addendum to ICH GCP, E6 (R2), includes the need for quality management (including risk-based stratification) across the clinical trial lifecycle.
The USC Initiative
The USC team’s research project involved the applied exploration, installation and implementation stages of the implementation science process by 1) exploring the need for a new initiative 2) disseminating results 3) engaging stakeholders 4) creating standard operating procedures (SOPs) for installation and implementation, 5) studying user satisfaction and effectiveness 6) addressing feedback and 7) conducting implementation. The team undertook an exhaustive literature review and determined that although numerous GCP training resources exist, most are too broad and lack the practical approaches to meet the complex requirements of monitoring.
Moreover, most of the offerings identified are costly or inaccessible. Based on the earlier established observation that 35% or so of IITs are not monitored there is a clear and present need for training tools that are easily available to a broader audience.
USC Monitoring Training Package
Researchers have identified that monitoring skills are substantially different than those associated with research coordination. It is clear that the surveyed research professionals believe that they would need additional training for competency. To address the need they began developing a monitoring module.
They engaged stakeholders from academia and industry to gain insights into their needs. USC reports that their training module is effective, they note supplementary information on the fundamental of clinical trials should be included for those new to the field.
The USC team conducted a form of pressure testing out in the field once they incorporated suggested changes to the training module from both academic and industry.
USC Training Module Dissemination
The USC team now is disseminating and sharing the self-study monitoring module with peers out in the field. They continue to engage stakeholders from academia, government and private institutions to understand and address quality changes in conducting clinical trials. The team notes that this overall efforts informs dissemination and implementation research, specifically for creating training for academic research professions.
TrialSite News Review
TrialSite News is actively involved with clinical trials research including systems-driven quality standards for accreditation developed by Alliance for Clinical Research Excellence and Safety (ACRES) Site Accreditation and Standards Initiative and clinical research site readiness services via ACRES ReServ.
Hence, we took a keen interest in the USC work product. The team did a review of literature published on the internet and summarizes the findings here. Generally the USC team has been out in the field evangelizing for the self-study monitoring training module; including engagement with the Trial Innovation Network and the Clinical & Translational Science Awards Program. A recent presentation summarizes most recent evangelization in the field and in a summary, presentation includes 1) definitions and roles 2) gaps in training at academic institutions 3) monitoring module development 4) interactive demonstrations 5) discussions.
In definitions and roles they introduce key regulatory, compliance and quality authorities to consider including the NIH given the focus on IITs as well as the standard stakeholders (e.g. IRB, investigator, sponsor, etc.). They remind the viewer of the comparison and contrast between the industry sponsored trial and the investigator-initiated trial. They raise our attention to recent ICH addendum such as 5.0 centering on quality. The remind the viewer of the difference of the quality function in the industry vs. the investigator-initiated study and remind us of the potential gap in IITs in regard to quality and monitoring.
Self-Study Module Description
For the self-study monitoring training module, the USC team highlights and shares how they are continuously eliciting feedback from stakeholders spanning industry and academia. Importantly they highlight their training module trajectory going from the introductory to the more complex including 1) discussion of monitoring concepts 2) discussion of advanced monitoring concepts 3) discussion of practical approaches to monitoring and 4) case studies incorporating monitoring into IITs.
TrialSite News offers access to our viewers to this important work product by USC. IITs drive considerable innovation and progress toward medical advancement.
Click create new account (right hand side)
- Type in your information and click Create my new account (bottom of page)
- Open your email and click the link to confirm your account
- Click course (middle of page)
- Scroll down (a little) and click Module 1—Clinical Trial Monitoring
It was a simple and easy registration process. Once registered you can access “the Clinical Trial Monitoring” module.
The actual self-study course involves the following:
- Monitoring Module Introduction: 16 min.
- Chapter 1: Fundamentals of Clinical Trials: 34 min
- Chapter 2: Clinical Trial Monitoring Concepts: 47 min
- Chapter 3: Monitoring Plans, Visits, and Reports: 65 min
- End of Module Case Studies: 17 min
- Monitoring Module Summary: 16 min
- Monitoring Documents
The USC team came together to contribute to the ongoing improvement of monitoring in IITs and they are to be commended. They have produced an incredibly useful core set of information that is easily accessible, free and provides a really decent overview to the vocational certainty associated with Clinical Monitoring. Academic institutions engaged in Investigator-Initiated Trials that don’t presently have formal monitoring programs should consider requiring this course of its research teams.
The ongoing work of the USC self-study Clinical Monitoring module is supported by grants from the National Center for Advancing Translational Science (NCATS) of the U.S. National Institutes of Health and of course investment made by University of Southern California (USC).
Amelia Spinrad, Project Administrator, USC
Nancy Pire-Smerkanich, Assistant Professor of Regulatory Sciences, USC
Eunjoo Pacifici, Associate Professor, Regulatory & Quality Sciences, USC
Apruva Uniyal, Project Director, Health Research Association
Annie Xie, Undergraduate Researcher, USC
Advaita Chandramohan, Undergraduate Research Associate, USC