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A referendum on clinical trial research in multiple sclerosis

The opinion of the participants at the Jekyll Island workshop

Department of Clinical Neurological Sciences, University of Western Ontario, London, Ontario, Canada.

Sixty-two experienced multiple sclerosis (MS) investigators attending a research workshop were asked their opinions about clinical trial design, outcome measures, and treatment. Respondents favored repeated clinical observations of neurologic function (eg, Expanded Disability Status Scale or Ambulation Index) over the opinion of a blinded physician and changes on magnetic resonance imaging. There was agreement that stable MS should not be treated with immunosuppressives. Corticosteroids were rated the most effective treatment for recent disease activity. Total lymphoid irradiation and immunosuppressives were judged more potent for the long-term management of progressive disease. No treatment, however, received the support of more than 11% of the respondents for being of "considerable efficacy" in the long-term management of MS. Most favored a placebo-con trolled design in future trials. In order to judge the acceptability of current trial design, participants were asked to act as patient surrogates and to indicate whether they would agree to participate in 4 randomized trials for which they would be eligible. The majority consented to participate in the 3 major trials currently under way, and most refused to enroll in the 1 trial that had never been initiated.

Address correspondence and reprint requests to Dr. Noseworthy, Department of Clinical Neurological Sciences, University Hospital, 339 Windermere Road, London, Ontario, Canada, N6A 5A5.

This work was funded by a grant from the Medical Research Council of Canada. Dr. J.H. Noseworthy is the recipient of a Career Development Award from the Multiple Sclerosis Society of Canada, and Dr. G.C. Ebers is a Career Scientist of the Ontario Ministry of Health.

Received February 1,1989. Accepted for publication in final form February 1,1989.

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