Abstract
It is necessary to understand the natural history of multiple sclerosis (MS) so that the results of clinical trials of experimental therapies can be interpreted. It is, in the final analysis, natural history studies that provide us with the data for rates of progression of disability and of survival in untreated patients, to which therapeutic trials are ultimately compared. Natural history data are used to determine sample sizes and provide us with the disability progression rates in untreated patients from which the magnitude of “placebo effects” in controlled clinical trials can be ascertained. For example, if we knew that 50% of an untreated population of relapsing MS patients deteriorated by a specified amount on an accepted measure of disability over 2 years, the sample size required to demonstrate confidently a designated percentage reduction (e.g., 50%) in this rate by a promising therapeutic agent could be calculated (see Chap. 4). Similarly, an estimate of the placebo effect could be made if the placebo-treated patients deteriorated less than otherwise properly matched and monitored untreated controls from natural history studies.
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Goodkin, D.E. (1992). The Natural History of Multiple Sclerosis. In: Rudick, R.A., Goodkin, D.E. (eds) Treatment of Multiple Sclerosis. Clinical Medicine and the Nervous System. Springer, London. https://doi.org/10.1007/978-1-4471-3184-7_2
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DOI: https://doi.org/10.1007/978-1-4471-3184-7_2
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