參考國(guó)內(nèi)外兒童中藥新藥臨床試驗(yàn)的相關(guān)法規(guī)與文獻(xiàn)，并結(jié)合筆者的實(shí)踐經(jīng)驗(yàn)，對(duì)兒童中藥新藥Ⅳ期臨床試驗(yàn)在試驗(yàn)?zāi)康?、總體設(shè)計(jì)、診斷標(biāo)準(zhǔn)選擇、病例納排標(biāo)準(zhǔn)、給藥方案、有效性評(píng)價(jià)、不良反應(yīng)觀察、試驗(yàn)流程、統(tǒng)計(jì)分析及倫理學(xué)要求等方面應(yīng)注意的事項(xiàng)提出了自己的看法，以期為兒童用藥Ⅳ期臨床試驗(yàn)及上市后再評(píng)價(jià)研究設(shè)計(jì)提供借鑒。

The author points out some special concerns on the designing, test purpose, diagnostic criteria for choosing, cases of inclusion, and exclusion criteria, dosage regimen, effectiveness evaluation, observation of adverse reactions, trial continuation process, statistical analysis, and ethics requirements in phase Ⅳ clinical trails of new drugs in Chinese materia medica for children, based on the relevant laws and regulations, literature reviews, and author's practical experience, so as to provide evidence for the phase IV clinical trials and postmarketing re-evaluation of children's drugs.

“十二五”重大新藥創(chuàng)制項(xiàng)目“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)”課題（2011ZX09302）