Study: 10% of FDA approved drugs since 2018 had pivotal trials that missed primary endpoints

About 10% of drugs approved by the US Food and Drug Administration (FDA) between 2018 and 2021 had pivotal trials with null findings, according to a research letter published in JAMA Internal Medicine.

“Our findings underscore the complexity of regulatory decision-making, as exemplified by evidence of effectiveness despite a null primary end point finding,” James L. Johnston, MD, of the department of medicine at Brigham and Women’s Hospital in Boston, and colleagues wrote in their research letter. “For other drugs, the evidence of efficacy was less clear.”