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Background We sought to characterize the perspectives of participants in Canada9s phase I/II chronic cerebrospinal venous insufficiency (CCSVI) clinical trial prior to and after the disclosure of trial results. Methods This was a researcher-administered survey of individuals who participated in Canada9s CCSVI trial (Clincialtrials.gov, NCT01864941) about their (1) motivations for participating, (2) understanding of the trial process, and (3) perspectives on the social value of the trial. Results A total of 63 participants completed the survey. Participants were motivated to participate by altruism (mean score = 4.56 out of 5) and a desire to access the intervention in Canada (mean score = 3.63 out of 5). Many participants expected medical benefits, such as partial disease reversal (mean score = 3.32 out of 5). Participants felt strongly that the crossover trial design promoted fairness (mean score = 4.65 out of 5). Participants9 familiarity with the CCSVI controversy increased significantly after the results were revealed (p = 0.0001). Despite negative trial results, participants still felt that the trial was an appropriate use of tax dollars (mean score = 4.68 out of 5). Many (38%) upheld the belief that further CCSVI research is necessary (responses of 4 out of 5 or higher). Conclusions There is a strong movement in science today to ensure that research agendas reflect the perspectives of multiple stakeholders, including research participants. While previous work suggests that negative findings adversely affect trust in science, the perspectives of participants in this study demonstrate that good trial design and resilience can prevail over expected tensions.
Benjaminy et al. (Fri,) studied this question.