《兒科常見疾病中藥新藥臨床試驗設計與評價技術指南》是中華中醫(yī)藥學會兒科分會臨床評價學組制定的、指導兒科中藥II期、III期臨床試驗和上市后有效性再評價方案設計的、具有病種特色的系列臨床評價技術指南,旨在推動兒科中藥臨床試驗設計與評價水平的提高,并為臨床提供安全有效的兒童用藥。采用世界衛(wèi)生組織(WHO)推薦的“共識會議法”和美國國立衛(wèi)生研究院(NIH)發(fā)展共識方案(GPP)有關原則,國內全部18個國家藥物臨床試驗機構中醫(yī)兒科專業(yè)的臨床兒科專家以及國內相關臨床評價專家參加了急性上呼吸道感染、急性支氣管炎、支氣管哮喘、反復呼吸道感染、厭食、輪狀病毒性腸炎、注意缺陷–多動障礙、抽動障礙、遺尿癥、手足口病、濕疹11個兒科常見病種指南的起草或多次提出修改建議,歷經3年反復完善,最終形成共識,并由中華中醫(yī)藥學會兒科分會于2013年10月發(fā)布。本指南從研究背景、研究目標、總體設計、診斷標準、受試者的選擇、給藥方案、安全性評價、有效性評價、試驗流程、數(shù)據(jù)管理與統(tǒng)計分析、質量保證、相關倫理學要求、試驗結束后的醫(yī)療措施、資料保存等方面闡述了小兒輪狀病毒性腸炎中藥新藥臨床試驗的設計與評價技術要點,期望能為申辦者與研究者在臨床試驗方案設計中提供指導。

The series of Guideline on evaluation of Chinese medical research for treatment of common disease in children were issued by Clinical Evaluation Unit, Pediatric Branch of China Association for Traditional Chinese Medicine. It is developed to assist applicants during the development and re-evaluation of pediatric medicine, in order to provide safer and better medicines for children. The guidelines were developed by all 18 clinical trial institutions of traditional Chinese medicine (TCM), utilized the “consensus meeting method”, which was recommended by WHO, and the consensus development program (GPP) principles of National Institutes of Health (NIH). It involved phases Ⅱ and Ⅲ to post marketing re-evaluation in 11 kinds of pediatric diseases, such as acute upper respiratory infection, acute bronchitis, bronchial asthma, recurrent respiratory tract infections (RRTI), anorexia, rotavirus gastroenteritis, attention-deficit/hyperactivity disorder, tic disorders, enuresis, hand-foot-and-mouth disease, and eczema. It spent three years form the first draft to the last version, after repeated revise, it was eventually released by CACM in October 2013. This Rotavirus Gastroenteritis Guideline intends to address the position in the main topics of clinical development of new Chinese medicinal products in the treatment of rotavirus gastroenteritis in children. The elaboration included possible claims, clinical study design, patients' selection, endpoints, safety observation, as well as other significant points. It aims at providing the possible guidance for sponsor and investigators of clinical trial.

國家重大新藥創(chuàng)制項目-“兒科中藥新藥臨床評價研究技術平臺規(guī)范化建設”(2011ZX09302-006-03)