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ResourcesHuman Research EthicsNew federal rules (US) target woeful public reporting of clinical trial results – STAT (Charles Piller September 2016)

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

New federal rules (US) target woeful public reporting of clinical trial results – STAT (Charles Piller September 2016)

Published/Released on September 16, 2016 | Posted by Admin on October 27, 2016 / , , , , , , , , ,
 


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WASHINGTON – Researchers will have to publicly report the results of many more clinical trials, including some for drugs and devices that never reach the market, under new government rules announced Friday.

The federal rules, which also require more complete reporting of deaths, clarify and strengthen a 2007 law that requires researchers to report results of many human studies of experimental treatments for ailments such as diabetes, cancer, and heart disease.

A STAT investigation last year found widespread noncompliance with reporting requirements by both drug companies and academic institutions — including universities that are among the top recipients of government research funding, and by National Institutes of Health staff scientists. In the vast majority of cases, study results were reported long after statutory deadlines or not at all.

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