《兒科常見疾病中藥新藥臨床試驗設(shè)計與評價技術(shù)指南》是中華中醫(yī)藥學(xué)會兒科分會臨床評價學(xué)組制定的、指導(dǎo)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(shè)計的、具有病種特色的系列臨床評價技術(shù)指南,旨在推動兒科中藥臨床試驗設(shè)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(guān)原則,國內(nèi)全部18個國家藥物臨床試驗機構(gòu)中醫(yī)兒科專業(yè)的臨床兒科專家以及國內(nèi)相關(guān)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(fù)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(jīng)3年反復(fù)完善,最終形成共識,并由中華中醫(yī)藥學(xué)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(biāo)、總體設(shè)計、診斷標(biāo)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(zhì)量保證、相關(guān)倫理學(xué)要求、試驗結(jié)束后的醫(yī)療措施、資料保存等方面闡述了兒童注意缺陷-多動障礙中藥新藥臨床試驗的設(shè)計與評價技術(shù)要點,期望能為申辦者與研究者在臨床試驗方案設(shè)計中提供指導(dǎo).

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 phase 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 from the first draft to the last version, after repeated revise, it was eventually released by CACM in October 2013. This Guideline intends to address the position in the main topics of clinical development of new Chinese medicinal products in the treatment of attention-deficit/hyperactivity disorder 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 sponsors 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(shù)平臺規(guī)范化建設(shè)"(2011ZX09302-006-03)