根據(jù)中國(guó)《藥品注冊(cè)管理辦法》，中藥新藥進(jìn)入臨床試驗(yàn)階段前需要進(jìn)行系列的非臨床研究，并以此作為背景資料。臨床試驗(yàn)作為藥物研究中具有決定性意義的一個(gè)重要環(huán)節(jié)，其研究結(jié)果最終決定一個(gè)藥品能否被批準(zhǔn)運(yùn)用于臨床，及其在臨床上如何使用。臨床試驗(yàn)方案設(shè)計(jì)的優(yōu)劣，直接關(guān)系到試驗(yàn)的成敗。簡(jiǎn)述中藥臨床試驗(yàn)方案的前期基礎(chǔ)工作以及需要注意的首要問題，包括文獻(xiàn)基礎(chǔ)、藥學(xué)基礎(chǔ)、藥效學(xué)基礎(chǔ)、安全性研究基礎(chǔ)和既往臨床研究基礎(chǔ)等。

According to the Management Method of Drug Registration, before the new drugs are used in clinical trials, non clinical studies are set as background information. Clinical trial as an important part of drug research has the decisive significance, and its research results could ultimately determine whether a drug would be approved in the clinical application, and its clinical use. The quality of clinical trial design was directly related to the success or failure of the test. This article briefly analyzed the work based on clinical trials of traditional Chinese medicine scheme and problems, including literature and pharmaceutical basis, pharmacodynamics, safety research foundation, and previous clinical research foundation.

國(guó)家“重大新藥創(chuàng)制”科技重大專項(xiàng)“兒科中藥新藥臨床評(píng)價(jià)研究技術(shù)平臺(tái)規(guī)范化建設(shè)”（2011ZX09302-006-03）