Article type
Year
Abstract
Objectives: To examine the prevalence and nature of such constraints.
Methods: Cohort study using protocols and corresponding publications for industry-initiated trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg in 1994-1995, and a sample of protocols from 2004.
Results: The sponsor had tight control over the trial in progress; in 16 trials from 1994-95, 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; only in one case was any of these facts stated in a trial report. In 22 of 44 trial protocols from 1994-95, it was stated that the sponsor either owned the data or needed to approve the manuscript, but such conditions for publication were not stated in any of the trial reports. An additional 18 protocols imposed other constraints on academic freedom. We found increased secrecy about publication agreements between investigators and sponsors in our sample of 44 protocols from 2004, and similar constraints on publication rights. Only one of the 88 protocols overall explicitly stated that there were no constraints.
Conclusions: The tight sponsor control over randomised trials should be changed to ensure research integrity. Transparency and reporting should also be improved, and trial protocols should be publicly available.
Methods: Cohort study using protocols and corresponding publications for industry-initiated trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg in 1994-1995, and a sample of protocols from 2004.
Results: The sponsor had tight control over the trial in progress; in 16 trials from 1994-95, 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; only in one case was any of these facts stated in a trial report. In 22 of 44 trial protocols from 1994-95, it was stated that the sponsor either owned the data or needed to approve the manuscript, but such conditions for publication were not stated in any of the trial reports. An additional 18 protocols imposed other constraints on academic freedom. We found increased secrecy about publication agreements between investigators and sponsors in our sample of 44 protocols from 2004, and similar constraints on publication rights. Only one of the 88 protocols overall explicitly stated that there were no constraints.
Conclusions: The tight sponsor control over randomised trials should be changed to ensure research integrity. Transparency and reporting should also be improved, and trial protocols should be publicly available.