HIV/AIDS Update - FDA launches new clinical trials demographic data page - seeking comments

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Title: HIV/AIDS Update - FDA launches new clinical trials demographic data page - seeking comments

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FDA recently released a new internet web page that will provide easy to understand demographic data for consumers including the age, race, and sex of participants in clinical trials for FDA-approved drugs and biologics. 

The information will be organized in a new document that FDA is calling Drug Trials Snapshots. Each Snapshot covers a single drug, providing a breakdown of the percentage of demographic subgroups participating in the drug’s pivotal clinical trials.

Also included is information about how the trial was designed and whether there were any observed differences in side effects and efficacy by sex, age and race/ethnicity.

Initially, FDA is posting a Snapshot of six new molecular entities (NMEs) that were approved by FDA between May and June 2014. Beginning next year, we intend to post a Snapshot for every approved NME and original biologic. 

FDA is seeking feedback from the public on the content, format and overall usability of the first six Snapshots. We welcome your comments.

 

You can comment on the content, format, and overall usability of the Drug Trials Snapshots [Docket No. FDA-2014-N-1818] at:
https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-27732.pdf

More about the Drug Trials  Snapshots:
http://www.fda.gov/Drugs/NewsEvents/ucm424178.htm 

The creation of this web page was one of the 27 action items in FDA’s 2014 Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data, issued in August.

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

 

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