Association of Funding and Conclusions in Randomized Drug Trials: A Reflection of Treatment Effect or Adverse Events?
CONTEXT Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions. 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 dru...
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Veröffentlicht in: | JAMA : the journal of the American Medical Association 2003-08, Vol.290 (7), p.921-928 |
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Sprache: | eng |
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Zusammenfassung: | CONTEXT Previous studies indicate that industry-sponsored trials tend to draw
proindustry conclusions. 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
publication). 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 |
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ISSN: | 0098-7484 1538-3598 |
DOI: | 10.1001/jama.290.7.921 |