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Participants in Clinical Trials Involving Placebos


Subject Matter

Health Canada wanted to conduct qualitative research with individuals who have taken part in placebo-controlled clinical trials. The purpose was to explore the attitudes and perspectives of individuals with first-hand experience in such trials. Areas of exploration included reasons or motivations for participating in clinical trials, concerns, perceptions of the process, including the issue of informed consent, and opinions on the use of placebos in clinical trials. The findings from this research were used to inform the ongoing debate regarding the ethical use of placebos in clinical trials. A year earlier, a set of focus groups with the general public and a couple of patient groups were conducted on the same issues. The results from that research were presented at a national conference on placebo use.

Methodology

A total of 30 in-depth interviews were conducted. In order to be able to recruit individuals with the needed experience (given privacy rules), assistance was provided by the Ottawa Hospital. A letter was sent from the head of the Research Ethics Board to doctors who had conducted clinical trials related to the treatment of various conditions. The doctors were asked to send information about this research to 20 of their patients, chosen at random, who had participated in a placebo-controlled clinical trial. The information included a letter informing individuals of the study, encouraging participation, and offering assurances of confidentiality, as well as a consent form for people to complete and return by mail should they be willing to participate. Those who returned consent forms were contacted by phone to schedule an interview. Quotas were established to ensure that individuals being treated for a variety of conditions were included in the research. Interviews were conducted in French and English.

 
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