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FDA’s Role in Increasing Diversity in Clinical Trials


On January 18, 2017, the New York Times published a letter to the editor titled “Diversity in Clinical Trials,” written by Dr. Robert Califf, Commissioner of the FDA, and Dr. Jonca Bull, Director of the FDA’s Office of Minority Health. The letter listed three priorities on which the FDA focused in order to ensure clinical trials of regulated medical products adequately reflected the patients likely to need them.

 

First, the FDA focused on improving data quality to ensure clinical trials of regulated medical products adequately reflected the patients likely to need them. To accomplish this goal, FDA biostatisticians, trial design experts, and quantitative scientists worked with the research community to develop methods to refine the conduct and analysis of trials to provide the best estimates of treatment effects for diverse populations.

 

Second, the FDA focused on increasing participation to ensure clinical trials of regulated medical products adequately reflected the patients likely to need them. The letter to the editor noted a particular example of this focus. Specifically, the FDA updated guidance to the industry to clarify expectations for enrolling clinical trial participants who reflect the affected populations with regard to age, gender, race, and ethnicity.

 

Third, the FDA focused on adding greater transparency to ensure clinical trials of regulated medical products adequately reflected the patients likely to need them. The letter to the editor noted a particular example of this focus. Specifically, the FDA created the Drug Trials Snapshots website to provide consumers with information about who participated in clinical trials that supported the FDA approval of new drugs. The information provided in these Snapshots also highlights whether there were any differences in the benefits and side effects among sex, race, and age groups.

 

These are all part of the FDA’s response to Section 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012. Section 907 directed the FDA to conduct an inventory of how well various population groups were being represented in clinical trials of FDA-regulated medical products and whether these data were publicly reported.

 

See the Department of Health and Human Services’ announcement

 

See the Letter to the Editor, “Diversity in Clinical Trials,” New York Times (January 18, 2017).

 

See the FDA Voice Blog Post, “2016: The Year of Diversity in Clinical Trials.”

 

See the FDA Drug Trials Snapshots

 

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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