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Demands from patient advocacy groups for broader subgroup representation in clinical trials has generated a new drug trial transparency initiative at the Center for Drug Evaluation and Research (CDER).
Demands from patient advocacy groups for broader subgroup representation in clinical trials has generated a new drug trial transparency initiative at the Center for Drug Evaluation and Research (CDER). The “drug snapshots” initiative is an important part of CDER efforts to enhance communication with the public about drug safety and efficacy, participation in clinical trials, and study design and results, commented CDER deputy director Douglas Throckmorton at the annual meeting of the Food and Drug Law Institute (FDLI) last week. By posting information on its website about demographic participation in key clinical trials for new drugs and biologics, FDA hopes to shed more light on whether a new therapy’s safety and efficacy differs related to sex, ethnicity or age.
CDER formally launched the drug snapshots program in January in response to concerns of patient advocates about whether women and minorities are adequately included in pivotal trials. The FDA Safety and Innovation Act of 2012 (FDASIA) required FDA to take a closer look at this issue. The result was an Action Plan released last August (2014) that called for greater transparency in demographic information from key studies for innovative drugs and biologics, along with efforts to increase subgroup participation in clinical research. CDER launched the snapshot program by posting six initial reports in November 2014. That provided an opportunity for public comment on the format and scope of the program, which rolled out formally at the beginning of this year. The plan is to post drug snapshots on all newly approved new molecular entities (NMEs) and original biologics going forward.
Each drug snapshot presents a summary of efficacy and safety data for the study overall and for demographic subgroups, with links to more in-depth data. This information has been available on the FDA website, but often is in different places and hard to find, pointed out John Whyte, director of CDER Professional Affairs and Stakeholder Engagement (PASE), in an FDA webinar April 27. Snapshots are written in consumer friendly language, highlight subgroup data and analyses, and are posted 30 days following drug approval. The scope and tone is quite different from approved package inserts that are more technical, designed for health care professionals, and finalized at approval.
While it’s important to increase minority group participation in clinical studies, Whyte hopes that the program will move beyond examining whether subgroups are adequately included in a trial, or if all studies should have 50% women. Equally important, he feels, is to ask what kind of subgroup analysis is needed to find meaningful differences. “The aim is to expand the discussion from whether a trial has to be proportionate, to what is the right number for a subgroup and why,” he said, noting that these issues generate notable differences in opinions among interested parties.
While some advocates might like to see Snapshots extended to all new drug approvals, which could occur in the future, FDA has no plan to cover investigational drugs nor to go back and develop listings for drugs approved in the past. Sponsors have no input on snapshot listings, but will be interested to see the results.