Healthy Skepticism Library item: 5660
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Gotzsche PC, Hrobjartsson A, Johansen HK, Haahr MT, Altman DG, Chan AW.
[Constraints on publication rights in industry-initiated clinical trials--secondary publication].
Ugeskr Laeger 2006 Jun 19; 168:(25):2467-9
Abstract:
In 22 of 44 industry-initiated clinical trial protocols from 1994-95, it was noted that the sponsor either owned the data or needed to approve the manuscript; another 18 protocols had other constraints. Furthermore, in 16 trials, the sponsor had access to accumulating data, and in an additional 16 trials the sponsor could stop the trial at any time, for any reason. These facts were not noted in any of the trial reports. We found similar constraints on publication rights in 44 protocols from 2004. This tight sponsor control over industry-initiated trials should be changed.
Keywords:
Clinical Trials*
Clinical Trials Data Monitoring Committees
Conflict of Interest*
Drug Industry*
Editorial Policies
English Abstract
Humans
Periodicals
Publishing*
Research Support
Research Support, Non-U.S. Gov't
