FDA discusses interim disclosure in CV outcomes trials

FDA met with industry and patient representatives Monday to discuss how to preserve trial integrity in two-stage cardiovascular outcomes studies that use a prespecified interim analysis to support approval and full results to fulfill postmarketing requirements.

Participants agreed that disclosing whether interim analyses meet the standard of approval would not jeopardize the remainder of the trial. But they said disclosing preliminary data about the hazard ratio, confidence interval or other safety signals could lead to slower enrollment, biased trial practices or uninterpretable results. ...