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.
Bidragets oversatte titel | Constraints on publication rights in industry-initiated clinical trials--secondary publication |
---|---|
Originalsprog | Dansk |
Tidsskrift | Ugeskrift for Laeger |
Vol/bind | 168 |
Udgave nummer | 25 |
Sider (fra-til) | 2467-9 |
Antal sider | 3 |
ISSN | 0041-5782 |
Status | Udgivet - 19 jun. 2006 |
Udgivet eksternt | Ja |
Emneord
- 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