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Clinical Trials and Medical Care: Defining the Therapeutic Misconception

  • Gail E Henderson mail,

    To whom correspondence should be addressed. E-mail: ghenders@med.unc.edu

    X
  • Larry R Churchill,
  • Arlene M Davis,
  • Michele M Easter,
  • Christine Grady,
  • Steven Joffe,
  • Nancy Kass,
  • Nancy M. P King,
  • Charles W Lidz,
  • Franklin G Miller,
  • Daniel K Nelson,
  • Jeffrey Peppercorn,
  • Barbra Bluestone Rothschild,
  • Pamela Sankar,
  • Benjamin S Wilfond,
  • Catherine R Zimmer
  • Published: November 27, 2007
  • DOI: 10.1371/journal.pmed.0040324

Reader Comments (7)

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Is the failure to recognise, outside of clinical trials, uncertainty about the effects of healthcare interventions the greatest therapeutic misconception?

Posted by plosmedicine on 31 Mar 2009 at 00:19 GMT

Author: Mike Clarke
Position: Director and Professor of Clinical Epidemiology
Institution: UK Cochrane Centre
E-mail: mclarke@cochrane.co.uk
Submitted Date: January 30, 2008
Published Date: January 30, 2008
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

Although the focus of this article is on misconceptions about clinical research, it is important to consider the need for people to be properly informed about uncertainty when they give, receive or take a healthcare intervention. This is important when there is uncertainty about an intervention that is being used outside of a clinical trial, and is regardless of whether or not a trial is available and whether or not the person giving, receiving or taking the intervention has sufficient knowledge to realise that they should be uncertain.

Perhaps patients who are given an intervention outside a trial for which the knowledge base shows that there should be substantial uncertainty about the intervention's beneficial or harmful effects need to be informed that they are actually being exposed to "research" of the lowest methodological quality. If there is uncertainty about the effects of an intervention, is it not more likely that it is the people giving, receiving or taking it outside of clinical trials who are suffering from the greatest "therapeutic misconception"?

Competing interests declared: I am employed by the Milton Keynes Primary Care Trust on behalf of the National Institute for Health Research in England, as Director of the UK Cochrane Centre. This is a fixed term contract, the renewal of which is dependent upon the value placed upon my work, that of the UK Cochrane Centre, and of The Cochrane Collaboration more widely by the Department of Health in England and others. I am also employed by Cancer Research UK to work at the Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), University of Oxford, primarily on systematic reviews of treatments for early breast cancer. Both of these jobs involve the conduct of systematic reviews, which are designed to help identify and resolve uncertainties about the effects of healthcare interventions (www.cochrane.co.uk; www.thecochranelibrary.com).