临床研究的组织形式及其特征研究

Features of Organization Modes for Clinical Research

摘要:

临床研究是医学研究的限速环节，也是诊疗方案、药物、医疗器械进入应用和市场的必经环节。通过设计合理的研究组织形式，形成不同类型的临床研究网络，是解决临床研究中资源分散、主体多样、研究缓慢等问题，提升研究质量和效率的主要做法。本研究对美国、英国所采用的综合型和专病型典型临床研究网络组织形式及其特征进行了梳理分析，基于我国当前临床研究网络建设的现状和问题，提出未来我国临床研究网络的主要发展路径，（1）提升研究型医疗机构的数量和能力；（2）自下而上的需求牵引与自上而下的指导建设相结合；（3）设立专门的临床研究网络管理主体及临床研究专项基金；（4）综合型和专病型临床研究网络的灵活组合；（5）更加扁平化的网络结构，研究实施主体下沉；（6）切实发挥研究网络的协同和资源融合作用。

Abstract:

As the speed-restricting phase in the medical research, clinical research is inevitable for the development of the drugs, medical devices and therapies. The main pathway to improve the quality and efficiency of clinical research is to cumulate the resources and actors, and to speed up the research process by organizing the clinical research networks. This study investigated and summarized the typical clinical research networks, i.e., the comprehensive and disease-specific clinical research networks in the UK and USA. Based on the analysis of current status and organization mode of the clinical research in China, we proposed 6 measures for the further improvement, i.e., improving the number and research capacity of medical centers (1st); combing the demands from the down-to-up clinical actors and the up-to-down strategic guidance (2nd), setting up the specific management institutes and the funds for the clinical research networks (3rd), the flexible combination of comprehensive and diseases-specific clinical research networks (4th), flatting the structure of clinical research networks and activating the research units (5th), and promoting synergy effect and the resource integration of actors within the research networks (6th).