July 5, 2022

OVERHAUL CLINICAL TRIALS, SAYS NIH

Procedures for clinical trials must be revised to protect the public and restore public faith in medicine, says the director of the US National Institutes of Health, Elias Zerhouni. He has released an eight-point plan to improve trials and reduce the prospect of ignoring adverse results.

A key recommendation is to give equal weight to safety and efficacy. The NIH feels that a focus on efficacy was one of the problems that ultimately led to the 2004 withdrawal of Merck’s pain killer Vioxx. It has also called for researchers to treat prior observations with greater scepticism, pointing to flaws in studies of hormone replacement therapy, which appears to be associated with a higher risk of circulatory disease. Statistics can also mislead both practitioners and patients, says the NIH, particularly when drug efficacy is discussed in terms of relative risk without reference to the absolute risk.