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.
Paul M. Ridker, M.D., of Brigham and Women’s Hospital, and Jose Torres, B.A., of Harvard Medical School, Boston, analysed 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 organisations and if the trial outcome favored newer treatments over the standard of care. Of the 324 trials, 21 cited no funding source.
For 202 randomised trials evaluating drugs, the proportions favouring 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 randomised trials evaluating cardiovascular devices, the proportions favouring 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 randomised trials published prior to 2000, these contemporary data appear to show that incentives surrounding for-profit organisations have the potential to influence clinical trial outcomes,” the authors write.
MEDICA.de; Source: Journal of the American Medical Association (JAMA)