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

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)制項目“兒科中藥新藥臨床評價研究技術(shù)平臺規(guī)范化建設(shè)”課題（2011ZX09302）