FDA Promotes Diversity in Clinical Trials

Sponsors are enrolling more women, elderly and ethnically diverse individuals in clinical studies, in response to pressure from FDA and Congress to examine more thoroughly whether important new drugs have different effects on different patient populations. After two years of tracking and disclosing data on patient subgroup enrollment through the Drug Trials Snapshots program, the agency finds a slight increase in diverse participation in studies for novel drugs and biologics.

The Drug Trials Snapshots summary report for 2015 and 2016, posted this week [see http://www.fda.gov/Drugs/InformationOnDrugs/ucm541105.htm] indicates that last year, women accounted for 48% of participants in studies for 22 important new drugs, up from 40% in studies supporting 45 new drugs in 2015. However, participation rose or declined only very slightly for different ethnic minorities. The amount of change, though, is more notable for certain groups enrolling in studies for mental health, oncology and cardiovascular disease therapies, which are broken out separately.

The report, which was required by the FDA Safety and Innovation Act (FDASIA) of 2012, is part of efforts to be more transparent on who participates in pivotal clinical trials supporting the approval of important new therapies. The Center for Drug Evaluation and Research (CDER) has posted “Snapshots” for each new molecular entity (NME) and original biologic (BLA) product during the past two years.

A main aim is to assess whether there are any observed differences in safety and efficacy by demographic subgroups at time of approval that may inform prescribing and dosing, explain CDER director Janet Woodcock and John Whyte, CDER director of professional affairs and stakeholder engagement, in a forward to the report. Sharing more information and facts about clinical trial participation, Whyte explained in an online posting, can help stimulate “a thorough and robust discussion about clinical trial demographics” [see http://www.fda.gov/Drugs/InformationOnDrugs/ucm541105.htm].  

For example, ACE inhibitors commonly used to treat high blood pressure have been shown to be less effective in African Americans than in white patients, Whyte notes. Sponsors recognize that new therapies for hypertension will help reduce disparities in health care for African Americans because of the high prevalence of heart disease in this population, according to a release from the Pharmaceutical Research and Manufacturers of America (PhRMA) [see http://catalyst.phrma.org/biopharmaceutical-industrys-success-reducing-disparities-for-african-americans]. PhRMA also points out that new diabetes treatments will help address such issues, as African Americans are 70% more likely to have diabetes than non-Hispanic Caucasians. But while the discovery of safe and effective antiretroviral medicines has helped reduce the death rate from AIDS in the U.S. by more than 70%, PhRMA notes only a 28% decline in deaths in the African-American community for persons living with HIV.