Abstract

This paper describes a method for identifying the knowledge used by experts in the design of clinical trials. The ideas presented in numerical displays are identified in the medical literature dealing with clinical investigations of the disease. These ideas are extracted, computerized, retrieved, and compared with those in the clinical trial protocol prepared by the experts. The agreements and differences between the two sets of ideas provide insights into the cognitive behavior of experts as they design the therapeutic trial. By tracing the ideas involved, it is possible to estimate the “creation trail” used by the experts. An example is given using the work of the Intergroup Rhabdomyosarcoma Study Committee (IRS). That committee has been the primary contributor of information dealing with the treatment of rhabdomyosarcoma in children. The IRS-III protocol was used in this analysis, because that protocol was adopted by the leading pediatric oncology clinical trial groups in North America and Europe. The Idea Analysis method was found to be useful in identifying most of the ideas used in constructing the IRS-III protocol. Those features which were not direct extensions of the data-supported ideas previously published in the literature could be identified and put into perspective. In most instances, the logic and precursors of the innovative ingredients could be identified.

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