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October 1983

Development of Simple Trial Protocols

Author Affiliations

From the Multiple Sclerosis Clinical and Research Unit, Department of Medicine, Division of Neurology, Brigham & Women's Hospital, Boston (Dr Weiner); and the Department of Neurology, University of Western Ontario, London (Dr Ebers).

Arch Neurol. 1983;40(11):700. doi:10.1001/archneur.1983.04050100040014

Because preliminary trials to determine toxicity and efficacy of new agents are described in many publications, the workshop group addressed only the question of large-scale controlled trials. Two points became clear in the discussion: (1) protocols must vary according to the stage of disease and the type of patients being studied, and (2) certain basic features are shared by all trial protocols and can be outlined for interested investigators who want to make sure that their trials are completed rigorously.

The group reviewed the essential features that must be considered in any protocol: the goal of treatment, the number and type of patients, the type of control group, randomization and stratification, double-blindedness, baseline management (irrespective of protocol considerations), and the persons who will carry out the trial.

The different categories of MS include acute attacks and relapsingremitting, chronic progressive, and chronic stable disease. Within each category, mild, moderate

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