2018年末，國家中醫(yī)藥管理局在《國家中醫(yī)臨床研究基地業(yè)務(wù)建設(shè)方案（專家論證編寫提綱）》中首次要求各個(gè)國家中醫(yī)臨床研究基地單位建立"藥物和醫(yī)療器械的臨床研究評(píng)價(jià)平臺(tái)"。從該平臺(tái)的職能、建設(shè)原則、目標(biāo)、組織形式、工作流程、內(nèi)部運(yùn)行機(jī)制等方面作為切入點(diǎn)，結(jié)合有關(guān)政策法規(guī)及文獻(xiàn)研究結(jié)果以及多年的臨床評(píng)價(jià)工作經(jīng)驗(yàn)，對(duì)如何建設(shè)藥物和醫(yī)療器械研究評(píng)價(jià)平臺(tái)，保障平臺(tái)各項(xiàng)職能有效落實(shí)，最大化地發(fā)揮平臺(tái)的作用，整合基地現(xiàn)有科研平臺(tái)，實(shí)現(xiàn)資源的優(yōu)化、共享等提出了可行的建議，以期為藥物和醫(yī)療器械的臨床評(píng)價(jià)科研平臺(tái)的建設(shè)提供參考。

At the end of 2018, the State Administration of Traditional Chinese Medicine issued the "The Business Construction Plans for National Traditional Chinese Medicine (TCM) Clinical Research Base (Experts' Compilation Outline)", in which the national TCM clinical research base units was requested for the first time to establish "Clinical Research Evaluation Platform for Drugs and Medical Devices". The author starts from the aspects of platform functions, construction principles, goals, organizational forms, workflows, internal operating mechanisms, etc. and combines years of base work experience, national policies and regulations, and literature research results. Specific suggestions were made on how to establish a research and evaluation platform for drugs and medical devices, ensure the effective implementation of various functions of the platform, maximize the role of the platform, integrate the existing scientific research platform at the base, and optimize the sharing of resources,in order to provide reference for the construction of the base scientific research platform. To our best knowledge, no research on the platform has been retrieved, since the publication of the document.

R969;R955

黑龍江省博士后基金項(xiàng)目（LBH-Z16201）；黑龍江中醫(yī)藥大學(xué)科研基金項(xiàng)目（201829）