摘 要：隨著新藥臨床研究的投入不斷增加，傳統(tǒng)的平行隨機對照研究設(shè)計不僅越來越成為新藥申辦者的障礙，同時也使臨床研究者、受試者受到更嚴格的倫理與更大風(fēng)險的束縛。臨床適應(yīng)性設(shè)計是指在臨床試驗開始后，根據(jù)試驗中已經(jīng)積累的信息，動態(tài)修改試驗規(guī)則和（或）統(tǒng)計規(guī)則的某些方面，以保證試驗的順利進行，而不破壞試驗的有效性、科學(xué)性和完整性的一種試驗設(shè)計。適應(yīng)性設(shè)計與傳統(tǒng)設(shè)計比較具有設(shè)計靈活、節(jié)約成本、縮短研發(fā)時間、加快新藥上市、符合倫理的優(yōu)點。綜述臨床適應(yīng)性設(shè)計產(chǎn)生的背景、主要內(nèi)容、類型，以及在新藥研究中的應(yīng)用與實施等。

Abstract: With the increase of investment and cost in clinical research and development，the traditional designs of randomized control trials become the obstacles for candidates，because of ethical problems，escalating costs and greater risks．Clinical adaptive design is referred to a modification or a change made to the trial and/or statistical procedure during a clinical trial based on the accumulated data，without undermining the validity and integrity of the trial．Compared with the traditional design，adaptive design method is to give the investigator more flexibility for identifying the best clinical benefits of the test treatment，and to make the trial faster，cheaper，and more ethical and efficient．This article reviews the background，types，strategies，and implementation of adaptive design in clinical trials．