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July 25, 2019

Harms From Uninformative Clinical Trials

Author Affiliations
  • 1Multi-Regional Clinical Trials Center, Harvard Medical School, Cambridge, Massachusetts
  • 2Stanford University School of Medicine, Stanford, California
  • 3Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada
JAMA. 2019;322(9):813-814. doi:10.1001/jama.2019.9892

Individuals who enroll in clinical trials do so with the belief that their participation will help to advance medical science. However, many trials are designed, conducted, and reported in ways that stymie this objective, a problem that can be called “uninformativeness.” From the perspective of researchers, this is a form of research inefficiency.1 But from the perspective of participants, preventable uninformativeness is a serious breach of trust and a violation of research ethics.

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    1 Comment for this article
    Imperfect, Yet Trials Still Have Impact on Disease
    Ron Louie, MD | University of Washington, Clinical Professor of Pediatrics
    This is an excellent piece about clinical trials and the frustrating waste of volunteers' "human capital," investigators' lack of expertise, the waste of money, and the already cumbersome regulatory process being less than competent to ensure that trials are done "right" and provide at least a minimum of information (ethics and the subjects' POV).

    The authors mention external funding issues and bias, but I think they focus on non-industry trials. I wasn't sure from their Viewpoint if industry-sponsored trials, with all their own baggage, are more or less informative? I would guess there would be a reluctance
    to publish the failure of a proprietary agent, not allowing failure analysis which still seems important.

    The reality is that clinical trials are so daunting (and the duration so "non-productive") for investigators that incentives usually have to be assured career advancement or other compensation. Bench results can come so much faster (informative, one hopes), why would a young person bother to work on a clinical trial?

    Altman's BMJ editorial "The Scandal of Poor Medical Research was published 25 years ago (1); his editor Richard Smith wrote a followup blog piece five years ago declaring things were no better (2). So where are we in medicine since then? I know that in my specialty, childhood cancer survival has improved, care in hemophilia and thrombosis has improved, but in other arenas, most notably Alzheimer's and dementia, there has been little to no progress (3). Could the Alzheimer's failures actually be a sign that the cumbersome imperfect system is inefficient but works, as frustrating as it is? The other issue there in dementia might be the lack of an overall therapeutic research strategy.


    1. https://www.bmj.com/content/308/6924/283
    2. https://blogs.bmj.com/bmj/2014/01/31/richard-smith-medical-research-still-a-scandal/
    3. https://alzheimergadfly.net/2018/08/28/spending-2-billion-on-alzheimers-a-fantasy/