2016 ‘Year of Diversity’ in Clinical Trials: Califf
FDA deputy commissioner for medical products and tobacco Robert Califf says that increasing diversity in clinical trial participants is a priority for the agency and “we want to make 2016 the year of more diversity in clinical trials.” Writing in an FDA Voice blog post, Califf reviews things the agency has learned and steps it has taken in implementing Section 907 of the FDA Safety and Innovation Act of 2012.
“Historically,” he writes, “the elderly, women (in some therapeutic areas), and racial/ethnic minorities have been under-represented in trials. A substantial body of literature has documented this under-representation in recent years, particularly for women in some cardiovascular trials and general inclusion of black/African-American and minority participants in clinical trials.”
In response to the Section 907 mandate to evaluate the issue and take action, he says, the agency created Drug Trials Snapshots that give the public readouts of the demographic profile of people participating in clinical trials for approved drugs. “While progress has been made,” Califf says, “we’ve learned from this program that we still have work to do. An evaluation of the Snapshots since the program began more than a year ago shows that some groups, especially ethnic and racial groups, aren’t always well represented in clinical trials.”
To help increase trial representation, he says, FDA plans these activities for 2016:
the FDA Office of Minority Health has developed tools to support clinical trial participation, including collaboration with the National Library of Medicine to help consumers and patients find clinical trials, educational materials on trials, and a multi-media campaign highlighting the importance of clinical trial participation; the FDA Office of Women’s Health launched a Diverse Women in Clinical Trials initiative to raise awareness and share best practices in clinical research design, recruitment, and subpopulation analysis; agency biostatisticians, trial design experts, and quantitative scientists will continue to work with the research community to develop methods to refine the approach to conducting and analyzing trials to provide the best estimate of treatment effects for diverse populations; continued commitment to include patient advocacy groups to engage patients in clinical trial design, feedback, and evaluation from a patient’s perspective; and the FDA Office of External Affairs plans to publish a consumer update describing what it is like to participate in a clinical trial and encouraging the public to enroll in trials if possible.