Association of Funding and Conclusions in Randomized Drug Trials

[Guest guest]

I would highly suspect most of the studies even if they were done by so called

" nonprofits " . They or the individuals involved are subject to undo influence

also, and usually are. Dollars usually make the rules bend.

 

A lot of industry led junk science now comes out of " non profits " . It makes it

more believable for awhile, until eventually they too will lose their

reputations for integrity.

 

Frank

 

http://jama.ama-assn.org/cgi/content/abstract/290/7/921

 

Association of Funding and Conclusions in Randomized Drug Trials

 

 

A Reflection of Treatment Effect or Adverse Events?

Bodil Als-Nielsen, MD; Wendong Chen, MD; Christian Gluud, MD, DMSc; Lise L.

Kjaergard, MD

 

JAMA. 2003;290:921-928.

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<.001; 2 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.

 

Author Affiliations: The Copenhagen Trial Unit, Center for Clinical Intervention

Research, Copenhagen University Hospital, Copenhagen, Denmark.

 

 

 

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JAMA. 2003;290:853.

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