Introduction
In an insightful discussion at a recent healthcare conference, Frank Conte, VP of Strategic Partnerships at Advarra, shared his expert views on the proposed single IRB mandate by the FDA and its broad implications for the research industry. This focuses on the key aspects of the mandate and how it could affect drug and device trials across the board.
Understanding the Single IRB Mandate
The single IRB mandate, as proposed by the FDA, is set to bring substantial changes to how clinical trials are reviewed and conducted. Frank Conte explains that unlike current rules, which are primarily focused on funding sources, the new mandate will apply universally to all drug and device trials regulated by the FDA. This shift aims to streamline the review process but introduces several challenges that institutions must navigate.
The Industry’s Response to the Mandate
During the conference, Conte discussed the industry’s mixed feedback during the FDA’s comment period, which lasted about 90 days. With some stakeholders expressing support and others raising concerns, the FDA is considering all input to refine the final rule. This rule, expected to be finalized later this year, will necessitate a reevaluation of existing protocols by research sites.
Preparing for Change: Insights from Advarra
Advarra is proactively preparing to support the industry through this transition. Conte highlighted the company’s commitment to thought leadership, including webinars and resources that will help sites and sponsors understand and implement the new mandate effectively. He also touched on the need for clear guidance from the FDA to facilitate smooth adoption across the industry.
The Broader Impact on Research Sites and Sponsors
Research sites need to start reviewing their current policies and procedures to prepare for the upcoming changes, as discussed by Conte. For sponsors, the mandate promises more streamlined operations, potentially increasing efficiency by centralizing IRB reviews. However, Conte also emphasized the continuing role of local IRBs and the need for their efficient engagement to avoid delays.
Conclusion
The FDA’s single IRB mandate represents a significant evolution in the regulatory landscape of clinical research. As Frank Conte from Advarra pointed out, while the changes pose challenges, they also offer opportunities for increased efficiency and faster progression of trials. Stakeholders across the industry should begin preparations now to adapt effectively to these new regulations.
