A considerable number of investigator-initiated trials (IITs) are not monitored at all. In fact, in at least 35% of all academic medical center, IITs exclude formal monitoring for ongoing tracking of quality, accuracy, and patient safety issues. This represents an unacceptable risk that a group of dedicated clinical trials professionals based out of the Southern California Clinical and Translational Sciences Institute (SC- CTSI) affiliated with University of Southern California (USC) decided to not only take on, but work tirelessly and relentlessly to proactively design, develop and implement a robust and accessible tool suite to help transform this material gap in the research world. The team developed a comprehensive, self-study module to help transform existing research coordinators and support staff at academic centers into effective monitors. A recent Webinar entitled, “Ensuring Quality: A Pilot Study to Establish a Monitoring Pool for Investigator-Initiated Trials” showcases this group’s impressive work to date. During the Webinar, the Los Angeles-based team introduces the IIT focused self-study monitoring tool, developed a half-year ago, and discusses the outcomes of the recent four-study real-world pilot. If embraced, adopted, and employed methodically and intelligently by academic centers around the country, the SC-CTSI-originated self-study monitoring tool can literally contribute to the creation of new pools of effective monitors for IITs and ultimately contribute to the improvement of IIT-based data quality and patient safety.
TrialSite News was pleased to follow up with the SC-CTSI/USC-based team as the article summarizing their transformative investigator-initiated trial (IIT) monitoring tool generated great interest with viewers. During this recent Webinar, the group, committed and dedicated to continuous clinical research improvements, reported on the results of the pilot of their IIT self-study monitoring tool. A well-attended event, the team reported pilot success.
The Challenge: Investigator-Initiated Trials Lack Systematic Monitoring
Investigator-initiated trials (IITs) are conducted for a variety of reasons from translating academic research into medical product development to exploring the expanded use of existing drugs for new uses to ongoing safety monitoring initiatives. Industry has rediscovered IITs as a creative and cost-effective method to innovate and further improve patient safety.
Last year, the USC-affiliated SC-CTSI team reported that 65% of IITs reported are fully monitored leaving at least 35% of all IITs not monitored at all. This alone represents a substantial volume of unmonitored research opening the door for potentially serious quality and participant safety questions. Moreover, the experienced SC-CTSI team believe that the actual number (of unmonitored trials) may be substantially higher—risking IIT outcome quality and potentially safety. Read our previous article covering the challenges associated with this gap.
Enter SC-CTSI Investigator-Initiated Trial Self-Study Training Module
The Southern California Clinical and Translational Sciences Institute (SC-CTSI) recently held a Webinar along with the Trial innovation Network to discuss the results of the IIT self-study monitoring module pilot involving four real-world studies. TrialSite News provides a basic summary below. All those interested in improving academic medical center IIT processes and outcomes should review this Webinar and consider adopting this tool. The goal: transform academic medical center clinical research coordinators into effective monitors employing risk-based monitoring planning and execution.
How well was the Webinar received?
Well! Out of the 89 professionals that registered, 55 attendees actually participated which was considered high. 30 attendees completed the exist survey and the overall satisfaction ranking was above satisfied.
Comments were directed to the team emphasized the importance of this work. The USC/SC-CTSI team is making a real contribution here.
What is the new IIT-focused self-study monitoring module?
Developed by SC-CTSI and the USC School of Pharmacy, the new self-study training monitoring module includes templates for study monitoring plans and reports, as well as SOPs and checklists for conducting monitoring visits. It is the first of a trio of resources for ensuring quality of clinical trials. The SC-CTSI team plans on additional modules, including one centered on the auditing of clinical research and another applied to site preparation and readiness for FDA inspections. TrialSite News can’t emphasize enough the potential value of this tool to those academic medical centers ready to embrace continuous improvement through education, training and organization of resources to introduce high quality monitoring to IITs.
How is this monitoring training influenced by an understanding of risk-based management principles?
The self-study module is profoundly influenced by concepts of risk-based monitoring. The SC-CTSI and USC-based designers of this important tool set to leverage the risk-based monitoring guideline adapted from NIH NIAID. They infuse risk-based approach “best-practices” directly into the module, which guides the formation of purpose-designed risk-based monitoring plans. This introduces an incredibly formidable tool to resource constrained academic research operations. Why? Because the underlying logic to help identify and mitigate risk with clinical trials comes along with the training.
How is the module accessed?
Absolutely free, the self-study module is accessible via a portal at the USC School of Pharmacy, Department of Regulatory and Quality Sciences website.
Why did the USC/SC-CTSI team design a pilot?
The team wanted to better understand how well the self-study monitoring module could impact actual research—in practice. With the goals of ensuring study data accuracy and validity, safety for study participants and to better understand the potential for how this approach could help support the evolution of Clinical Research Coordinators (CRCs) into monitors.
What was the pilot design?
The team identified four (4) real-world studies for the pilot. The selection criteria involved a number of factors, such as risk and of course a study prerequisite—they had to be investigator-initiated trials. Studies were categorized by type of study, type of population, funding source, and were ultimately analyzed and stratified by risk.
How long did the pilot take?
The pilot took a little over 7 months—nearly double the amount of time originally planned for. This was due to a number of factors primarily involving unexpected delays caused by scheduling conflicts, communication turnaround times, staff turnover, protocol amendment updates, and the like.
What were the Pilot findings?
Overall, this pilot can be considered a substantial success based on three overall findings, including 1) the pilot monitoring results showcased the overall effectiveness of the quality improvement initiative supporting more accurate and valid data, greater attention to patient safety and need to offer continuous training to CRCs at SC-CTSI; 2) pilot monitor plans when applied in the field produced material findings related to risks that were corrected –supporting feasibility in continuous quality improvement for these IIT pilot samples; and 3) findings indicate that the team could create a monitoring tool out of the existing participating SC-CTSI clinical research coordinators. More broadly, the SC-CTSI pilot study indicates that the well-planned and methodical utilization of the self-study module for monitoring supports the creation and expansion of clinical research coordinator pools to improve more monitoring coverage of IITs.
What are the next steps for the SC-CTSI team?
First and foremost, the SC-CTSI team will disseminate the findings of the pilot. It is important that professionals involved with academic medical research based IITs be aware that this tool is available. Second, the team will expand this initiative to include other tools to support an overarching quality-by-design (QbD) framework for IITs. Third, tools on the roadmap include Module 2 (Auditing) and Module 3 (Site Readiness for FDA Inspections). Finally, the team plans to explore other value-added training targets and collaborations with other organizations.
About the SC-CTSI
The SC-CTSI is one of 60 NIH-funded Clinical Translational Science institutes, involving a mandate to boost efficiency and quality of translational research. Services offered by this group include biostatistics and bioinformatics, education, career development and ethics; clinical translation/clinical trials unit; preclinical translation and regulatory support; continuous quality improvement, research development, and translational research informatics. SC-CTSI also works in partnership with core facilities at USC, including animal care and resources; cell culture; cytometry; genomics; histology; imaging; proteomics; therapeutic design, discovery & development; transgenic/knockout mouse in vivo models, and vector design and construction.
The Core Team
Eunjoo Pacifici, PharmD, PhD Chair and Associate Professor, Department of Regulatory and Quality Science Director, Regulatory Knowledge and Support, SC CTSI
Nancy Pire-Smerkanich, DRSc, MS Associate Professor, Department of Regulatory and Quality Science
April Armstrong, MD, MPH Associate Dean and Professor of Dermatology Director, Clinical Research Support, SC CTSI
Nicki Karimipour, PhD Interim Associate Director, Communications & Clinical Research Support, SC CTS
Note, many others participated in supporting this core team in the development of the self-study module for IIT monitoring.
Call to Action: Visit the Webinar hosted by SC-CTS and Trial Innovation Network here.