We need bias assessments tools for drug studies that take funding source into account.
Professor Lisa Bero, Charles Perkins Centre, University of Sydney
The authors note there are several potential ways that
industry sponsors can influence the outcome of a study, including the
framing of questions, the design of a study, the conduct of a study, how
data are analysed, selective reporting of favourable results, and
“spin” in reporting conclusions.
Also, while some journals now require that the role of the sponsor in the design, conduct and publication of the study be described, this practice is not widespread.
Professor Bero said the key concern associated with industry-sponsored research evaluating drugs and medical devices was that there were no standard tools or validated criteria that include industry sponsorship as a risk of bias for such studies.
“We need bias assessments tools for drug studies that take funding source into account,” Professor Bero said. “Currently, we have no validated way to detect or evaluate these subtle but systematic biases.”
“Our views about the effectiveness and safety of many medicines may be distorted. Medicines may be both less safe and less effective than we think to the extent that the evidence about them comes from the companies making them," he said.
Also, while some journals now require that the role of the sponsor in the design, conduct and publication of the study be described, this practice is not widespread.
Professor Bero said the key concern associated with industry-sponsored research evaluating drugs and medical devices was that there were no standard tools or validated criteria that include industry sponsorship as a risk of bias for such studies.
“We need bias assessments tools for drug studies that take funding source into account,” Professor Bero said. “Currently, we have no validated way to detect or evaluate these subtle but systematic biases.”
Key findings
Compared to non-industry sponsored studies, industry sponsored drug and medical device studies:- More often had efficacy results that were more favourable to the sponsor’s product
- More often had favourable overall conclusions
- Had less agreement between stated results and overall conclusions
“Our views about the effectiveness and safety of many medicines may be distorted. Medicines may be both less safe and less effective than we think to the extent that the evidence about them comes from the companies making them," he said.