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

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