May 3, 2024
@
1:30 pm
–
4:00 pm
Meeting of The Research, Development, and Regulatory Roundtable (R3). Meetings are open to R3 Sponsors. To learn more about how to become an R3 Sponsor, click here.
Topics:
- Recent Developments in FDA Guidance on Real World Evidence
- Subject-Directed Recruitment Materials and Testimonials
Abstract: Real World Evidence and Emerging Trends in Clinical Trial Subject Recruitment
Real World Evidence
In recent years, real-world evidence (“RWE”) has increasingly been incorporated into product development programs, spurred by greater access to RWE, legislative changes, and significant policy development at FDA. The use of RWE raises novel opportunities, as well as new challenges for regulators, clinical trial sponsors, and the life sciences and healthcare industry to set common standards for RWE to ensure it can be relied upon with confidence in regulatory decision-making.
During 2023, FDA released two draft and three final guidance documents concerning RWE. These included the following:
- Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (Draft, February 2023)
- Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products (Final, August 2023)
- Use of Real-World Evidence to Support Regulatory Decision-Marking for Medical Devices (Draft, December 2023)
- Data Standards for Drug and Biological Product Submissions Containing Real World Data (Final, December 2023)
- Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products (Final, December 2023)
This session will provide an overview of key concepts from these guidance documents, focusing in particular on how they intersect with FDA’s existing regulations on clinical investigations and how they may change the regulatory landscape. In addition to focusing on these recent FDA guidance documents, the speakers will address the application of other U.S. regulatory regimes to RWE activities, including the Common Rule, the Information Blocking Rule, and HIPAA and other data privacy laws.
Clinical Trial Subject Recruitment Trends
Clinical trial sponsors are increasingly exploring different techniques to attract potential subjects to clinical trials, particularly in the context of rare disease studies for which subjects may be difficult to find. These techniques have included the following:
- Use of testimonials featuring active clinical trial subjects in clinical trial advertisements
- Inclusion of detailed scientific information gathered in pre-clinical or Phase 1 studies in subject-directed recruitment materials
- Partnerships with electronic health record vendors to identify potential trial sites or subjects
Each of these techniques raise novel regulatory questions, including concerns about pre-approval promotion, data bias, need for institutional review board review and approval, and data privacy.
This session will analyze these trends and the attendant regulatory considerations for each.
