Study examines reported outcomes of trials funded by for-profits vs. not-for-profits

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Public release date: 16-May-2006

http://www.eurekalert.org/pub_releases/2006-05/jaaj-ser051106.php

Contact: Myron

JAMA and Archives Journals

Study examines reported outcomes of trials funded by for-profits vs.

not-for-profits

Cardiovascular clinical trials published between 2000 and 2005 were

significantly more likely to report positive findings if they were

funded by for-profit organizations than those funded by not-for-profit

organizations, according to a study in the May 17 issue of JAMA.

Surveys of randomized trials published between 1990 and 2000 raised

awareness in the medical community that trials funded by for-profit (FP)

organizations were more likely to report positive findings than those

funded by not-for-profit (NFP) organizations. These surveys raised

questions regarding the design and conduct of industry funded clinical

trials as well as certain ethical concerns, according to background

information in the article. Whether recognition of these concerns has

affected contemporary clinical trials was unknown.

M. Ridker, M.D., of Brigham and Women's Hospital, and ,

B.A., of Harvard Medical School, Boston, analyzed outcomes of 324

cardiovascular clinical trials published between 2000 and 2005 in JAMA,

The Lancet, and the New England Journal of Medicine, stratifying the

results on whether the trial was funded by for-profit or not-for-profit

organizations and if the trial outcome favored newer treatments over the

standard of care. Of the 324 trials, 21 cited no funding source.

Overall, 58.6 percent of the 324 trials reported evidence significantly

favoring newer treatments, while 34.6 percent reported no significant

difference between therapies, and 6.8 percent reported evidence

significantly favoring standard of care. Among not-for-profit trials, 49

percent of 104 reported evidence significantly favoring newer

treatments, whereas 51 percent either significantly favored standard of

care or showed no difference.

Among for-profit trials, 67.2 percent of 137 reported evidence

significantly favoring newer treatments with 32.8 percent reporting data

favoring standard of care or no difference. The proportion of trials

significantly favoring new treatments for studies jointly funded by

for-profit and not-for-profit organizations was approximately midway

between these 2 values (56.5 percent).

For 202 randomized trials evaluating drugs, the proportions favoring

newer agents were 39.5 percent for not-for-profit, 54.4 percent for

jointly sponsored, and 65.5 percent for for-profit trials. For the 38

randomized trials evaluating cardiovascular devices, the proportions

favoring newer treatments were 50.0 percent, not-for-profit; 69.2

percent, jointly funded; and 82.4 percent, for-profit trials.

Regardless of funding source, clinical trials using surrogate end

points, such as intravascular ultrasound, quantitative angiography,

plasma biomarkers, and functional measures were more likely to report

positive findings (67.0 percent) than were clinical trials using

clinical end points (54.1 percent).

" As suggested in surveys of randomized trials published prior to 2000,

these contemporary data appear to show that incentives surrounding

for-profit organizations have the potential to influence clinical trial

outcomes. Previous attempts to explain this phenomenon have focused

largely on design bias, interpretation bias, data suppression, and

differential data quality, " the authors write.

" … we believe there are additional issues that help to explain, in

part, the observed results. For example, when the first trial report of

a truly novel therapy is null or negative, it becomes less likely that

any funding source will support subsequent studies. On the other hand,

when the first trial of a truly novel therapy is positive, the

likelihood of further trials is increased. These subsequent trials

understandably and perhaps appropriately are more likely to be funded by

for-profit organizations, " the researchers write.

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(JAMA. 2006;295:2270-2274. Available pre-embargo to the media at

www.jamamedia.org)

--

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