[Skip to Navigation]
August 15, 2017

Balancing the Need for Access With the Imperative for Empirical Evidence of Benefit and Risk

Author Affiliations
  • 1Duke Health and Duke University School of Medicine, Durham, North Carolina
  • 2Verily Life Sciences, South San Francisco, California
JAMA. 2017;318(7):614-616. doi:10.1001/jama.2017.9412

When people use medical products, they generally expect that the benefits of doing so will outweigh the risks in terms of living longer, feeling better, or improving their functional status. However, most drugs and biologics and many medical devices that enter early evaluation in humans are found either to have no benefit or to have risks that outweigh the observed benefits when proper clinical trials are conducted. The complexity and high failure rates of medical product development have appropriately led to a regulatory system that requires compelling evidence of safety and efficacy from clinical trials for drugs, biologics, and high-risk devices before they are allowed on the market.