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October 1983

Common Problems in Designing Therapeutic Trials in Multiple Sclerosis

Arch Neurol. 1983;40(11):678-680. doi:10.1001/archneur.1983.04050100018006

The use of randomized clinical trials to demonstrate treatment efficacy is not new. Brown et al1 detailed many important aspects of clinical trials several years ago. Investigators may fail to secure funding for such research because of their lack of experience in writing proposals for therapeutic clinical trials. Some of the more common problems perceived by reviewers are discussed herein, and some advice is offered to help proposal writers avoid recognized pitfalls.

A surprisingly large number of treatments for multiple sclerosis (MS) are becoming available for clinical testing, and several tests have been funded by the National Institutes of Health. As the availability of treatments for MS is a relatively new phenomenon, some clinicians lack experience in planning this kind of clinical study but quickly learn that clinical trials are often difficult to set up properly and carry out effectively. Even experienced clinical researchers sometimes undertake investigations that are