Disclosure of clinical trial results when product development is abandoned

Michael A Rogawski, Howard J. Federo

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Currently, sponsors are not required to report the outcomes of clinical research on drugs or devices that do not lead to an approved product. Consequently, the public cannot benefit from scientific information derived from all failed or abandoned drugs and devices. Provisions in the U.S. Food and Drug Administration Amendments Act of 2007 provide an opportunity for the Department of Health and Human Services to rectify this situation. By reporting the results of clinical trials of abandoned products in a publicly accessible database and in the peer-reviewed journal literature, sponsors would satisfy a core ethical obligation of clinical research and enhance translational science.

Original languageEnglish (US)
Article number102cm29
JournalScience Translational Medicine
Volume3
Issue number102
DOIs
StatePublished - Sep 28 2011

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Disclosure
Clinical Trials
United States Dept. of Health and Human Services
Equipment and Supplies
Translational Medical Research
United States Food and Drug Administration
Pharmaceutical Preparations
Outcome Assessment (Health Care)
Databases

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Disclosure of clinical trial results when product development is abandoned. / Rogawski, Michael A; Federo, Howard J.

In: Science Translational Medicine, Vol. 3, No. 102, 102cm29, 28.09.2011.

Research output: Contribution to journalArticle

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