title: [Constraints on publication rights in industry-initiated clinical trials--secondary publication].
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.
authors.affiliation: H:S Rigshospitalet, Det Nordiske Cochrane Center, DK-2100 København Ø. pcg@cochrane.dk
authors.forename: Peter C
authors.initials: PC
authors.lastname: Gøtzsche
authors.forename: Asbjørn
authors.initials: A
authors.lastname: Hróbjartsson
authors.forename: Helle Krogh
authors.initials: HK
authors.lastname: Johansen
authors.forename: Mette T
authors.initials: MT
authors.lastname: Haahr
authors.forename: Douglas G
authors.initials: DG
authors.lastname: Altman
authors.forename: An-Wen
authors.initials: AW
authors.lastname: Chan
mesh_terms: D026661:Clinical Trials Data Monitoring Committees; D002986:Clinical Trials as Topic; D016265:Conflict of Interest; D004345:Drug Industry; D035081:Editorial Policies; D006801:Humans; D010506:Periodicals as Topic; D011643:Publishing; D012109:Research Support as Topic