PhRMA: Easing Speech Limits Could Reduce Need For Subgroups In Trials

As FDA faces pressure from consumer groups to mandate demographic subgroup participation in trials, the pharmaceutical industry argues a better solution is to let industry communicate real-world information about the safety and effectiveness of marketed products. Attendees at a recent FDA public meeting on the implementation of a federal action plan to encourage greater use of demographic subgroup data in new drug and device applications urged the agency to mandate inclusion of specific populations in clinical trials as a contingency...