• Ugeskrift for laeger · Jun 2006

    [Constraints on publication rights in industry-initiated clinical trials--secondary publication].

    • Peter C Gøtzsche, Asbjørn Hróbjartsson, Helle Krogh Johansen, Mette T Haahr, Douglas G Altman, and An-Wen Chan.
    • H:S Rigshospitalet, Det Nordiske Cochrane Center, DK-2100 København Ø. pcg@cochrane.dk
    • Ugeskr. Laeg. 2006 Jun 19; 168 (25): 2467-9.

    AbstractIn 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.

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