Industry sponsorship and selection of comparators in randomized clinical trials
Article first published online: 27 DEC 2009
© 2009 The Authors. Journal Compilation © 2009 Stichting European Society for Clinical Investigation Journal Foundation
European Journal of Clinical Investigation
Volume 40, Issue 2, pages 172–182, February 2010
How to Cite
Lathyris, D. N., Patsopoulos, N. A., Salanti, G. and Ioannidis, J. P. A. (2010), Industry sponsorship and selection of comparators in randomized clinical trials. European Journal of Clinical Investigation, 40: 172–182. doi: 10.1111/j.1365-2362.2009.02240.x
- Issue published online: 13 JAN 2010
- Article first published online: 27 DEC 2009
- Received 6 November 2009, accepted 11 November 2009
- industry sponsoring;
- randomized clinical trials
Eur J Clin Invest 2010; 40 (2): 172–182
Background Most clinical trials on medical interventions are sponsored by the industry. The choice of comparators shapes the accumulated evidence. We aimed to assess how often major companies sponsor trials that involve only their own products.
Methods Studies were identified by searching ClinicalTrials.gov for trials registered in 2006. We focused on randomized trials involving the 15 companies that had sponsored the largest number of registered trials in ClinicalTrials.gov in that period.
Results Overall, 577 randomized trials were eligible for analysis and 82% had a single industry sponsor [89% (166/187) of the placebo-control trials, 87% (91/105) of trials comparing different doses or ways of administration of the same intervention, and 78% (221/285) of other active control trials]. The compared intervention(s) belonged to a single company in 67% of the trials (89%, 81% and 47% in the three categories respectively). All 15 companies strongly preferred to run trials where they were the only industry sponsor or even the only owner of the assessed interventions. Co-sponsorship typically reflected co-ownership of the same intervention by both companies. Head-to-head comparison of different active interventions developed by different companies occurred in only 18 trials with two or more industry sponsors.
Conclusions Each company generates a clinical research agenda that is strongly focused on its own products, while comparisons involving different interventions from different companies are uncommon. This diminishes the ability to understand the relative merits of different interventions for the same condition.