Blog | Friday, September 21, 2012

QD: News Every Day--Internists look askance at industry-funded studies

Study design, not industry funding, should be the key reason why internists doubt results from a clinical trial, a study concluded.

Internists in a study discounted hypothetical examples of small, poorly designed trials and accepted outcomes from large trials that tested clinical end points. But they also downgraded the credibility of hypothetical industry-funded trials compared with the same trials attributed to NIH funding or having no source of support listed.

But should internist pay more attention to well-design studies despite industry funding?

Researchers presented 269 board-certified internists (a 53.5% response rate) with one of 27 possible abstracts describing clinical trials of three hypothetical drugs: "lampytinib" for dyslipidemia in patients who had unacceptable side effects from statins, "bondaglutaraz" for diabetes and low levels of HDL cholesterol in patients taking metformin and a sulfonylurea and unable to add insulin, and "provasinab" for angina in patients with untreatable multivessel coronary disease who were taking maximal doses of beta-blockers.

The hypothetical abstracts varied the drug being tested, the trial's methodologic rigor (high, medium or low), and the funding source (industry, NIH or none).

Results appeared in the New England Journal of Medicine.

Physicians reported that they were less willing to prescribe drugs tested in low-rigor trials than those tested in medium-rigor trials (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.46 to 0.89; P=0.008). They were more willing to prescribe drugs tested in high-rigor trials than those tested in medium-rigor trials (OR, 3.07; 95% CI, 2.18 to 4.32; P less than 0.001).

Disclosure of industry funding, as compared with no disclosure of funding, led physicians to downgrade the rigor of a trial (OR, 0.63; 95% CI, 0.46 to 0.87; P=0.006), their confidence in the results (OR, 0.71; 95% CI, 0.51 to 0.98; P=0.04), and their willingness to prescribe the hypothetical drugs (OR, 0.68; 95% CI, 0.49 to 0.94; P=0.02). Physicians were half as willing to prescribe drugs studied in industry-funded trials as they were to prescribe drugs studied in NIH-funded trials (OR, 0.52; 95% CI, 0.37 to 0.71; P less than 0.001). These effects were consistent across all levels of methodologic rigor.

Researchers noted that excessive skepticism concerning industry-supported trials could hinder how internists practice. They cited an example of a poll conducted at NEJM in which many of readers believed that the results of the JUPITER trial did not justify a change in clinical management, citing industry funding as a key reason.

"Although attention to potential sources of bias is necessary, such skepticism apparently can also reduce the credibility and acceptance of even high-quality research that is industry-supported," the researchers wrote. "Financial disclosure is important, but more fundamental strategies, such as avoiding selective reporting of results in reports of industry-sponsored trials, ensuring protocol and data transparency, and providing an independent review of end points, will be needed to more effectively promote the translation of high-quality clinical trials--whatever their funding source--into practice."