[Constraints on publication rights in industry-initiated clinical trials--secondary publication].
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.
Gøtzsche
Peter C
PC
H:S Rigshospitalet, Det Nordiske Cochrane Center, DK-2100 København Ø. pcg@cochrane.dk
Hróbjartsson
Asbjørn
A
Johansen
Helle Krogh
HK
Haahr
Mette T
MT
Altman
Douglas G
DG
Chan
An-Wen
AW
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