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Comment & Response
September 2015

A Potential Solution for Research Misconduct

Author Affiliations
  • 1Cactus Communications, Trevose, Pennsylvania
  • 2AVP Medical Affairs, Cactus Communications, Mumbai, India
JAMA Intern Med. 2015;175(9):1587. doi:10.1001/jamainternmed.2015.3229

To the Editor Seife1 raises an important issue with respect to the challenges encountered when searching for information on registration studies in published literature. Seife’s research focused on official research misconduct as designated by the US Food and Drug Administration (FDA) classification of official action indicated. In his research, he uncovered a lack of published safety data updates that would have publicly addressed FDA findings of research misconduct at clinical trial sites that was serious enough to require regulatory action. Publication of such information would have provided amended published safety data vs what appeared in the initial clinical trial publication. In an accompanying editorial, Steinbrook and Redberg2 comment that a limitation of Seife’s research was a likely underestimation of the degree of actual research misconduct or failure to update clinical trial safety information because the frequency of serious problems could not be estimated owing to the number of missing or unavailable records.

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