Clinical Trial Enrollment: OIG Approves Another Patient Cost-Sharing Proposal Designed to Increase Socioeconomic Diversity

Mar 29, 2022

Posted by Sidley Austin

Clinical trial enrollment continues to present challenges to sponsors seeking to identify, recruit, and enroll patients in their clinical studies. A recent government opinion from the U.S. Department of Health and Human Services Office of Inspector General (OIG) recognizes the importance of eliminating socioeconomic factors that function as a barrier to clinical trial enrollment. This latest opinion continues a current trend of government opinions approving certain programs that subsidize patient cost-sharing obligations in clinical trials, notwithstanding OIG’s long-held concerns with “problematic seeding arrangements.” Continue reading

See all Member News