Let the reader beware
Surveys of randomized trials published 1990-2000 raised awareness in the medical community that trials funded by FP organizations were more likely to report positive findings than those funded by NFP groups. These surveys raised questions regarding design and conduct of industry-funded clinical trials and certain ethical concerns, according to information in the article. Whether recognition of these concerns has affected contemporary clinical trials was unknown.
Dr. Paul M. Ridker, of Brigham and Women’s Hospital, and Jose Torres, of Harvard Medical School, analyzed outcomes of 324 cardiovascular clinical trials published 2000-2005 in JAMA, The Lancet, and the New England Journal of Medicine, stratifying results on whether the trial was funded by FP or NFP 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% of the 324 trials reported significant evidence favoring newer treatments, while 34.6% reported no significant difference between therapies, and 6.8% reported significant evidence favoring standard of care. Among NFP trials, 49% of 104 reported evidence significantly favoring newer treatments, while 51% either favored standard of care significantly or showed no difference. Among FP trials, 67.2% of 137 reported evidence significantly favoring newer treatments, with 32.8% reporting data favoring standard of care or no difference.
The proportion of trials significantly favoring new treatments for studies funded jointly by FP and NFP organizations was 56.5%.
For 202 randomized trials evaluating drugs, the proportions favoring newer agents were 39.5% for NFP, 54.4% for jointly-sponsored, and 65.5% for FP trials. For the 38 randomized trials evaluating cardiovascular devices, the proportions favoring newer treatments were 50.0%, NFP; 69.2%, jointly-
funded; and 82.4%, FP trials.
“As suggested in surveys of randomized trials published prior to 2000, these contemporary data appear to show incentives surrounding [FP] 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 wrote.
“ … 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 [FP] organizations,” the researchers wrote.