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Compliance In Focus
Posted by Brandy Chittester on Tue, Dec 18, 2012

Could Industry Sponsored Clinical Trials be Biased?

A recent article published by the Cochrane Group examined industry sponsorship and researchCould Industry Sponsored Clinical Trials be Biased outcome. In order to gather the necessary data, researchers conducted a systematic review of 48 reports of studies involving drugs and medical devices. The results may have researchers rethinking the way medical review and guidelines are handled.

The group did not focus on one therapeutic area- instead; the researchers looked into products for a wide range of conditions and diseases. The focus was specifically on the results and conclusions of the study and whether they were favorable to the sponsor.

According to the article’s objectives, the group investigated whether:

  • Sponsorship of drug and device studies by the pharmaceutical and device industries is associated with outcomes, including conclusions, that are favorable to the sponsor;
  • Drug and device studies sponsored by the pharmaceutical and device industries differ in their risk of bias compared with studies with other sources of sponsorship

The researchers observed that drug and device “studies sponsored by the manufacturing company more often had favorable results and conclusions than those that were sponsored by other sources.” The question is still up for debate as to whether this is a direct result of the industry’s sponsorship? Or, perhaps the manufactures fund the trials that are more likely to have successful outcomes.

How may this information change the research industry?

Results from research studies affect how clinicians recommend treatments, practice medicine, and advocate therapies to patients. Perhaps increased transparency in things like study funding sources and raw data will help paint a complete clinical trial picture.

The researchers also make a bold statement in the conclusion of the paper that “industry sponsorship should be treated as bias-inducing and industry bias should be treated as a separate domain. There are many subtle mechanisms through which sponsorship may influence outcomes, and an assessment of sponsorship should therefore be used as a proxy for these mechanisms.”

We’re anxious to see what our peers think of this study and the results. Please voice your opinion below. We look forward to your thoughts.

Photo Credit: yoni sheffer

Significant Risk/Non-Significant Risk Determination 

Topics: Industry Sponsored Clinical Trials, Cochrane Group, Research Industry

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