publication . Article . Other literature type . 1990

THE ROLE OF INTERNAL PILOT STUDIES IN INCREASING THE EFFICIENCY OF CLINICAL TRIALS

Wittes, Janet; Brittain, Erica;
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  • Published: 01 Jan 1990 Journal: Statistics in Medicine, volume 9, pages 65-72 (issn: 0277-6715, eissn: 1097-0258, Copyright policy)
  • Publisher: Wiley
Abstract
SUMMARY Investigators often design clinical trials without knowing precisely the values of such necessary parameters as the variances or the event rates in the control group. In order to determine reasonable values for such parameters, they may design a small pilot study external to the main trial. In this paper we propose designs, which we term internal pilot studies, that designate a portion of the main trial as a pilot phase. At the end of the internal pilot study, the investigators recompute preselected parameters and recalculate required sample size. The study then proceeds with the modifications dictated by the internal pilot. Final analyses of the results...
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