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Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of Funding and Conclusions in Randomized Drug Trials: A Reflection of Treatment Effect or Adverse Events? JAMA. 2003;290(7):921–928. doi:10.1001/jama.290.7.921
Author Affiliations: The Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark.
Context Previous studies indicate that industry-sponsored trials tend to draw
Objective To explore whether the association between funding and conclusions in
randomized drug trials reflects treatment effects or adverse events.
Design Observational study of 370 randomized drug trials included in meta-analyses
from Cochrane reviews selected from the Cochrane Library, May 2001. From a
random sample of 167 Cochrane reviews, 25 contained eligible meta-analyses
(assessed a binary outcome; pooled at least 5 full-paper trials of which at
least 1 reported adequate and 1 reported inadequate allocation concealment).
The primary binary outcome from each meta-analysis was considered the primary
outcome for all trials included in each meta-analysis. The association between
funding and conclusions was analyzed by logistic regression with adjustment
for treatment effect, adverse events, and additional confounding factors (methodological
quality, control intervention, sample size, publication year, and place of
Main Outcome Measure Conclusions in trials, classified into whether the experimental drug
was recommended as the treatment of choice or not.
Results The experimental drug was recommended as treatment of choice in 16%
of trials funded by nonprofit organizations, 30% of trials not reporting funding,
35% of trials funded by both nonprofit and for-profit organizations, and 51%
of trials funded by for-profit organizations (P<.001; χ2 test). Logistic regression analyses indicated that funding, treatment
effect, and double blinding were the only significant predictors of conclusions.
Adjusted analyses showed that trials funded by for-profit organizations were
significantly more likely to recommend the experimental drug as treatment
of choice (odds ratio, 5.3; 95% confidence interval, 2.0-14.4) compared with
trials funded by nonprofit organizations. This association did not appear
to reflect treatment effect or adverse events.
Conclusions Conclusions in trials funded by for-profit organizations may be more
positive due to biased interpretation of trial results. Readers should carefully
evaluate whether conclusions in randomized trials are supported by data.
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