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Curiosity, Altruism Influence “Human Guinea Pigs”

30 October, 2012 by David Finer

A study on participants in clinical trials (“human guinea pigs”) challenges the basic assumption that one can distinguish specific from non-specific treatment effects. It also shows that curiosity, altruism and status-seeking are part of the reason why people take part in clinical trials. 

In his plenary talk at ECIM 2012, Professor George Lewith (one of I C´s two Scientific Advisors) discussed a published qualitative study on the placebo phenomenon, showing how participants in clinical trials “forge” convictions about participation and treatment.

New theory of active participation
The study has led to the formulation of a new ”theory of active trial participation” with far-reaching consequences for the field of clinical trials, on which, it might be added, much of our ”evidence-based” healthcare system relies.

Actually, the study was part of a trial of acupuncture with participants with a diagnosis of hip or knee osteoarthritis. Out of 1472 patients approached, 221 consented and were randomized to receive one of three interventions: real acupuncture, sham needle acupuncture, or a non-needle placebo which consisted of skin pads connected to a mock electrical stimulator. Out of the 209 patients who completed the trial, 27 were interviewed: eighteen females and nine males, aged between 52 and 78 years.

Experiences of participation in the clinical trial were grouped into three categories: “making a commitment” (to the trial), “maintaining the commitment” and “producing an outcome”. “Forging convictions” reflected a dynamic process that underpinned all aspects of trial participation and was labeled as the core category.

Various reasons for taking part
The theory suggests that individuals take part in clinical trials because of a combination of reasons:

  • curiosity
  • altruism
  • the desire for some kind of personal gain
  • personal or vicarious experiences of the treatment under investigation and
  • the status gained as a research participant.

The convictions that draw them into the trial are strengthened during the research process by such factors as welcoming and supportive administration, and the status, professionalism and interest of the practitioner. If the participant is satisfied with these experiences, they reinforce a sense of commitment to the study and enable individuals to overcome considerable barriers, including lack of personal benefit, to complete the trial. When asked to report on outcomes, participants actively seek out positive or negative cues to defend their convictions about the nature of the study and their role in it.

Challenges core assumption
The study challenges one of the fundamental assumptions of the clinical trial: that is possible to distinguish specific from non-specific treatment effects. As discussed by other researchers, this study showed that how clinical trial participants understand the meaning of trials may influence their biomedical outcomes. In the acupuncture trial, it seems clear that the therapeutic benefits observed in the real and control interventions were contextually driven.

An important question for orthodox and complementary medicine remains whether or not environmental and interpersonal components of the therapeutic encounter should be controlled for, or dismissed as incidental, when they are actually an integral part of treatment and important determinants of the therapeutic outcome, say the authors of the study.

David Finer

Read more

Scott C, Walker J, White P, Lewith G. Forging convictions: the effects of active participation in a clinical trial. Soc Sci Med. 2011 Jun;72(12):2041-8. Epub 2011 May 18.

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