Abstract Details

Title Perspectives of Participants in a Multisite Canadian CCSVI Clinical Trial

Topic Practice, Policy, and Ethics

Presentation(s) S50 - Practice, Policy, and Ethics (4:03 PM-4:14 PM)

Poster/Presentation
Number 004

Background

The CCSVI hypothesis for the pathogenesis of MS incited tremendous hope in the MS community. This response was prominent in Canada where CCSVI received considerable media attention. Participants in Canada’s CCSVI trial may hold unique motivations for participating in the trial and have a vested interest in the study results.

Objective

We sought to characterize the perspectives of participants in Canada's phase I/II chronic cerebrospinal venous insufficiency (CCSVI) clinical trial prior to and after the disclosure of negative trial results.

Design/Methods This was a researcher-administered survey of participants in Canada's 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). Participants' 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 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.

Authors/Disclosures
Cody Lo (University of British Columbia) PRESENTER	No disclosure on file
Shelly Benjaminy (Dr. Judy Illes)	No disclosure on file
J M. Girard, MD	Dr. Girard has nothing to disclose.
	No disclosure on file
Anthony Traboulsee, MD (University of British Columbia)	Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Traboulsee has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EMD Serono. Dr. Traboulsee has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. The institution of Dr. Traboulsee has received research support from Roche. The institution of Dr. Traboulsee has received research support from Genzyme. The institution of Dr. Traboulsee has received research support from Consortium of MS Centers. The institution of Dr. Traboulsee has received research support from MS Canada. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving as a Workshop Chair with Consortium of MS Centers.
Judy Illes, PhD, CM (UBC, Div of Neurology, Dept Medicine)	Dr. Illes has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Stanford University. Dr. Illes has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier Press. The institution of Dr. Illes has received research support from NIH, CIHR, North Family Foundation, FRQ. Dr. Illes has received publishing royalties from a publication relating to health care. Dr. Illes has a non-compensated relationship as a Distinguished University Professor and Distinguished Professor in Neuroethics with University of British Columbia that is relevant to AAN interests or activities.

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