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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.

Type

Journal article

Journal

Ugeskr laeger

Publication Date

19/06/2006

Volume

168

Pages

2467 - 2469

Keywords

Clinical Trials Data Monitoring Committees, Clinical Trials as Topic, Conflict of Interest, Drug Industry, Editorial Policies, Humans, Periodicals as Topic, Publishing, Research Support as Topic