When Do Doctors Discount Clinical Trial Results?

Jonathan Darrow Conflicts of Interest, Empirical, FDA, Human Subjects Research, Jonathan Darrow

by Jonathan J. Darrow

A research study reported today in the New England Journal of Medicine found that physicians are able to discriminate between clinical trials with high levels of rigor versus those with low levels of rigor, as well as between clinical trials that are funded by industry and those that are funded by the government.

The randomized study analyzed the responses of 269 physicians who were presented with hypothetical abstracts of clinical trial findings for three hypothetical drugs.  Abstracts were deliberately crafted to reflect three levels of clinical trial rigor (low, medium, and high), and three types of funding disclosure (no disclosure, National Institutes of Health funding, and pharmaceutical industry funding), yielding 27 abstract types.

The major finding of the study was that physicians are less willing “to believe and act on trial findings, independent of the trial’s quality,” if the trial is funded by industry.  That industry funding led to a decrease in perceived credibility, even for large and well-designed trials, concerned the study authors, who felt that “[t]he methodologic rigor of a trial, not its funding disclosure, should be a primary determinant of its credibility.”

The full article citation is: Aaron S. Kesselheim et al., A Randomized Study of How Physicians Interpret Research Funding Disclosures, 367(12) New Eng. J. Med. 1119 (Sept. 20, 2012). Available here.

[Editorial Note: And within the et al. is Chris Robertson, a former Petrie-Flom Academic Fellow, current prof at University of Arizona, and future guest blogger here at Bill of Health!]

Jonathan Darrow

Dr. Jonathan J. Darrow is a an Assistant Professor at Harvard Medical School and the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham & Women's Hospital. He received his research doctorate (SJD) in pharmaceutical policy from Harvard University, where he completed an LLM program in intellectual property (waived), as well as degrees in genetics (BS), law (JD), and business (MBA) from Cornell University, Duke University, and Boston College. After qualifying for the California and Patent bars in 2001 and 2002, Dr. Darrow served as a senior law clerk at the U.S. Court of Appeals for the Federal Circuit, worked in private law practice at Cooley LLP and Wiley Rein LLP, taught on the faculties of four universities and for the World Intellectual Property Organization, authored several law textbooks, supported the intellectual property divisions of WHO and WTO, lectured widely on issues of FDA regulation, and published numerous articles on issues such as expanded access, the breakthrough therapy designation, competition policy, pharmaceutical patenting, gene therapies, drug efficacy, biological products, therapeutic vaccines, and expedited development and approval programs. He is an author of several textbooks, including Cyberlaw: Management & Entrepreneurship (Cengage 2012; Aspen 2015), The Legal and Ethical Environment of Business (Aspen 2014 and Wolters-Kluwer 2d ed. 2018), and Business Law and Management for Entrepreneurs (Edward Elgar, forthcoming). He has lectured widely on issues of FDA regulation, and published numerous articles on issues such as expanded access, the breakthrough therapy designation, competition policy, pharmaceutical patenting, gene therapies, drug efficacy, biological products, therapeutic vaccines, and expedited development and approval programs.

0 thoughts to “When Do Doctors Discount Clinical Trial Results?”

  2. Every group does this. No one ever believed the studies the tobacco companies put out about the effects of smoking. The first thing environmentalists do with studies that don’t support their narrative is attack the funding source. Politicians discount poll results when the poll is funded by their opposition’s party. So what did we learn here? Sounds like doctors are humans too; just don’t let them know that.

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