Investigator Initiated Trials Increasingly Impacted by FMV Concerns
Investigator initiated trial (IIT) management teams must incorporate fair-market value (FMV) into their payment protocols to appropriately respond to regulatory scrutiny and maintain compliance. In our new study, “Investigator Initiated Trial Management,” 23 percent of study participants ranked oversight or intervention from the Office of Inspector General (OIG) as their number one IIT management challenge. In response to regulatory pressures, many top drug makers have been forced to sign corporate integrity agreements (CIAs) with the OIG, a costly move requiring them to establish formal processes surrounding thought leader interactions.
New Study Identifies Potential Improvement Opportunities
“Scrutiny over payments has affected all physician-facing functions in the life sciences industry, but as IITs grow increasingly important to corporate strategy, it’s equally important that medical affairs teams standardize practices and follow FMV protocol,” said Ryan McGuire, senior research analyst and the study’s lead author.
The study identified three key improvement opportunities to avoid direct OIG oversight. First, analysis about FMV concerns must become a formal part of the IIT proposal review process, and teams should check the investigator’s budgets against databases of clinical trial costs. Second, companies should invest in documentation tools that accurately monitor aggregate spending to avoid overpaying. Third, companies should use milestone payments to track investigator services.
“Executives interviewed for this study said investigators are too often unaware of the extent that regulatory rules determine standard operating procedures, as well as their own responsibility to conduct a compliant study,” said Adam Bianchi, chief operating officer. “With sound practices agreed upon by global, regional and subfunction leadership, IITs are well-positioned to create a strategic ‘meeting of the minds’ of medical affairs and clinical development strengths.”
The new study contains benchmarks and best practices to reinforce IIT management and execution from proposal submission through study completion. The data include IIT team structures, budgets and spending, and team goals and challenges. The information focuses on key goals identified by benchmarking partners:
- Use digital systems to accelerate and streamline proposal receipt, review and approval.
- Meet growing needs with dedicated resources and appropriate spending to ensure smooth operations.
- Build a standardized structure to manage and track IITs.
- Align objectives for study conclusion and the use of data findings with product strategy.