General considerations on adaptive designs for clinical trail and drug evaluation

Abstract

Abstract: Adaptive design is a trial design that allows modifications to some aspects of the trial after its initiation without undermining the validity and integrity of the trial. Adaptive design makes it possible to discover and rectify inappropriate assumptions in trial designs, reduce development costs and the time to market. It has been very attractive to the pharmaceutical industries. In this paper, it is not focused on adaptive designs for clinical trials with multiple endpoints studied using computer simulations, but is to clarify our evolution, which is taken into consideration in a trial adaptive design at present, if need modifications.

Key words: KEYWOEDS adaptive designs, interim analysis, independent data monitoring committee, clinical biostatistics

ZHAO Chao. General considerations on adaptive designs for clinical trail and drug evaluation[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2008, 13(1): 1-5.

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