Phrma: Easing Speech Limits Could Reduce Need for Subgroups in Trials

Joe Williams, Insidehealthpolicy.Com: March 7, 2016

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 of approval.

A representative for the pharmaceutical lobby, however, said that such a requirement would prolong clinical trials, and instead said allowing drug companies to share truthful, non-misleading information that does not impact the risk-benefit profile of approved medications would allow industry to communicate data on safety and effectiveness in subgroups in the postapproval space.


Ulrich said it was necessary to balance getting the perfect answer with the need to provide medicines to those patients who need them.

Drug and device approvals over the past few years show a lack of representation by key subgroups in clinical trials. Tracy Rupp of the National Center for Health Research said that of the 15 premarket approval devices reviewed by advisory committees in 2014, 60 percent did not include at least 30 African Americans, three had less than 10 and some had zero represented. In the same year, Rupp said one-third did not specify whether any individuals 65 years of age or older participated.

“Most devices that would be used by both men and women did not include subgroup analysis to determine if the device was safe and effective for both sexes,” she said.


Better communication to inform potential clinical trial participants about the possible benefits to their own health, broader sharing of results and improved compensation were other strategies attendees said could encourage more subgroup involvement in studies.

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