New Issue Brief: Slow, Costly Clinical Trials Drag Down Biomedical Breakthroughs

Global health depends on an effective American biotech industry

New York, NY – America should be a locus of scientific innovation and invention, but its global leadership in the biotech industry is increasingly hampered by rising clinical trial costs. In a new Manhattan Institute issue brief, adjunct fellow Willy Chertman, M.D. identifies the causes of this rapid increase and makes recommendations for reversing it.

Chertman points to a 2014 report commissioned by the U.S. Department of Health and Human Services as a useful starting point, arguing that it offers promising recommendations to bring down costs. These include clarifying areas of regulatory overlap or ambiguity and promoting more transparency from Institutional Review Boards. The issue brief’s other recommendations include:

• Deregulating advertising for clinical trials: Current advertising regulations make recruitment for clinical trials slow and costly, so while FDA should keep strict standards for truthfulness, it should allow for more aesthetic freedom to attract more participants.
• Boosting tax incentives for trial participants: Payment for participating in any clinical trial should be tax deductible, as is already the case for trials related to rare diseases. This would be a straightforward way to boost overall trial participation and improve socioeconomic diversity among participants.
• Walking back diversity mandates: While racial diversity among participants can be scientifically significant, recent “diversity guidance” all but requires adopting burdensome practices that have no proven benefits.
• Modernizing trial monitoring: Rather than requiring in-person double-checking of every piece of data, FDA should promote widespread adoption of a more streamlined "risk-based monitoring" approach. It can do this by providing better top-down guidance and updating education and recognition programs for data reviewers.  

Chertman demonstrates that such changes can lower costs and accelerate timelines on clinical trials, ensuring better treatments for America and the world. 

Read the full issue brief here.