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Clinical Study Report Release Could Compromise Patient Privacy, Groups Say

 
• By Derrick Gingery

US FDA's plan to post CSRs may also inadvertently release confidential commercial information, agency is warned by industry groups.

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The FDA redacted data in the clinical study reports, but there was no assurance it was truly anonymized, BIO said. • Source: Shutterstock

The US Food and Drug Administration is releasing information in clinical study reports that could help hackers identify patients, some groups said in formal comments about the idea.

Former Commissioner Scott Gottlieb spearheaded releasing clinical study reports (CSRs), which are scientific documents containing detailed summaries of clinical trial methods and results, as part of the action packages published...

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