The Use of Auxiliary Information in the Design of a Clinical Trial

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Abstract
Strategies are investigated for the incorporation of auxiliary information into the design of a clinical trial to compare 2 treatments. The response to treatment is assumed normally distributed with unknown mean .mu.A or .mu.B and known variance .rho.2. The only cost considered is the ethical one of treating a patient with the wrong treatment. Out of a total of N patients with the disease in question, a fraction 2P of them is to be placed in a clinical trial comparing the 2 treatments, with the winning treatment to be given to the remaining N(1-2P) patients. The direct information from the trial is combined with information from an outside source in order to make the final decision. Strategies investigated are a Bayes strategy and a 2-stage strategy in which the auxiliary information alone is considered in stage 1.

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