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Abstract:
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In general, patients enter a Phase II clinical trial sequentially and hence their responses to the treatment are reported consecutively. A long observational period is required, when the accrual rate is low and the treatment period is long. Simon's two-stage designs (1989) have recently employed to avoid giving patient an ineffective drug. Thus if the new drug is ineffective then this design definitely would shorten the drug development process. However, for a promising new drug this design may still require a long observation period. Therefore, this paper proposes an alternative curtailed two-stage design to shorten drug development process as soon as the treatment shows lack of efficacy or very effective. The savings in patient accrual compared to Simon's designs is about 5% and 40% for very low and high null response rates, respectively.
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