People Participate In Clinical Trials For Self And Societal Benefit

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Main Category: Clinical Trials / Drug Trials
Also Included In: Public Health;  HIV / AIDS
Article Date: 27 Jun 2008 - 0:00 PDT

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A survey of patients participating in a clinical trial for a new HIV therapy found that the majority of the patients not only sought to personally benefit from the trial, but also realized that participating in research can contribute to society as a whole. Results of the study are published in the June 23 issue of Archives of Internal Medicine.

Why do people volunteer for clinical trials? Researchers have been increasing efforts to answer this question, but they still lack information that explains the motivations of patients' continuing participation in trials. David Wendler, Ph.D. (Department of Bioethics, National Institutes of Health Clinical Center) and colleagues ask, "Why do patient participants, especially those randomized to a control group, continue to accept the added risks and burdens, e.g., additional clinic visits and extra research procedures, that clinical research places on them?" This question is of particular importance, according to the researchers, "Given the view that clinical research inappropriately exploits patient participants by exposing them to added risks and burdens for the benefit of others."

The survey data come from participants in a phase 3 trial that is designed to compare antiretroviral medications alone to the medications paired with an immune system-related protein called interleukin 2 (IL-2). The Evaluation of Subcutaneous Proleukin (Interleukin-2) in a Randomized International Trial (ESPRIT) study consists of HIV-infected patients from Argentina, Brazil and Thailand, and those who had been enrolled for at least six months were asked to respond to a survey that probed their motivations and experiences.

A total of 582 participants responded to the survey, 290 from the antiretroviral medication group and 292 from the group that also received IL-2. Choosing from a list of 12 reasons for remaining in the trial, "More than 80 percent indicated that the opportunity to obtain medical or personal benefit and the opportunity to help others were very important reasons for continuing to participate." In addition, "90 percent believed they were making an important contribution to society, and 84 percent expressed pride in helping to advance scientific knowledge."

According to the researchers, their results indicate that several reasons can motivate patients to persist through clinical research, even with its risks and burdens. The authors add: "Most importantly, the fact that respondents were motivated to obtain treatment for a life-threatening illness did not preclude them from being motivated to help others through their participation in the ESPRIT study as well."

"These findings reveal that it is possible to conduct clinical research in developing countries without exploiting patient participants' failure to understand that they are participating in research and without exploiting their need for medical treatment to get them to contribute to goals that they do not endorse," conclude the authors.

Why Patients Continue to Participate in Clinical Research
David Wendler, PhD; Benjamin Krohmal; Ezekiel J. Emanuel, MD, PhD; Christine Grady, PhD, RN; for the ESPRIT Group
Archives of Internal Medicine (2008). 168[12]: pp. 1294 - 1299.
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Written by: Peter M Crosta


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