Is this new drug safe for your patient?

How do you know if the new drug you’re about to prescribe to a patient was tested on people of the same gender, ethnicity or age? In late February, the U.S. Food and Drug Administration (FDA) released its first report on the diversity of participants in clinical trials to help inform the extent to which safety and effectiveness data are based on demographic factors. Prescribers can see the breakdown of trial participants, by drug, on the FDA’s Drug Trials Snapshots webpage.

FDA’s Drug Trials Snapshots Report (2015-2016)

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Clinical trial participants, 2015
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Clinical trial participants, 2016

* The percentages of the categories “American Indian or Alaska Native (AI/AN),” “Native Hawaiian or Other Pacific Islander (NH/OPI),” and “Unknown/Unreported” were small enough that we combined them into the “Other” category for the purposes of this review. 

**These subgroups were calculated as part of a Geriatrics Report and are not a regular feature of the Drug Trials Snapshots.

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Email us your feedback and comments: PatientSafetyBeat@BetsyLehmanCenterMA.gov