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FDA Report on Test Subject Diversity When Testing New Drugs


On February 13, 2017, the FDA published its Drug Trials Snapshots Summary Report, which provided a yearly average of the diversity of participants in the clinical trials for novel drugs approved in 2015 and 2016. Until the late 1980s, clinical trials were conducted predominantly on men. It is important to test drugs on diverse patient populations because some drugs affect different patient populations differently. This is especially true for novel drugs, new medicines that have never before been used in the U.S. marketplace.

 

Over the past two years, the FDA’s Center for Drug Evaluation and Research (CDER) approved 67 novel drugs. Consequently, representation in clinical trials of certain subgroups, such as people of different ages, races, ethnic groups, and genders, has become of growing interest.

 

As part of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA 907), the U.S. Congress required the U.S. Food and Drug Administration (FDA) to report on the diversity of participants in clinical trials and the extent to which safety and effectiveness data is based on demographic factors such as sex, age, and race. Recognizing the lack of easily accessible information about participation in drug trials, two years ago, CDER piloted a new transparency initiative called the Drug Trials Snapshots program to provide easily accessible information about patient representation in clinical trials.

 

Drug Trials Snapshots show who participated in the studies used to approve a novel drug and organize information from the studies by sex, race, and age subgroups. Further, they provide a brief narrative on whether there were any reported differences in how the drug worked by subgroup and whether there were any reported differences in side effects among the different groups. Since January 2015, CDER has published a Drug Trials Snapshot within a month of each novel drug’s official approval date.

 

The FDA’s 2015-2016 Drug Trials Snapshots Summary Report summarizes the first two years of the Drug Trials Snapshots program and is broken down by calendar years 2015 and 2016. Each calendar year provides an overall average of each demographic group followed by a more detailed summary table of the percent representation of sex, race, and age per clinical trial. The report showed, for example, that women were represented at a rate of 40 percent in 2015 and 48 percent in 2016 and African Americans were represented at a rate of 5 percent in 2015 and 7 percent in 2016. The report also laid out the extent to which safety and effectiveness data were based on demographic factors such as sex, age, and race.

 

See the FDA Drug Trials Snapshots Summary Report

 

See also the FDA Voice Blog Post

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

See also Medical Law Perspectives, March 2012 Report: Off-Label Use of Prescriptions: When is this Medical Malpractice? Is the Pharmaceutical Company Liable for Overpromotion? 

 

 

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