关于加强临床试验研究者团队建设的对策探讨

Measures for Enhancing Clinical Research Investigator Capability Building

目的:建设高质量、专业化的临床试验研究者团队,提升团队人员研究能力和水平,推动我国临床研究快速健康发展。方法:通过分析临床试验核查中发现的问题,查找问题产生的原因,提出建设稳定、高效、高质量的临床试验研究者团队的重要性和必要性,并进一步探讨临床试验研究者团队建设的策略。结果与结论:多数临床研究中出现的问题和缺陷均与研究者团队人员遵循《药物临床试验质量管理规范》(GCP)的原则性不强、研究能力不足有关。只有加强临床试验研究者团队建设,才能从根本上推动临床研究高质高效发展。主要研究者作为临床试验研究者团队的总指挥,在临床试验实施过程中起关键作用,是临床试验质量的保证者。笔者建议可以通过宣教培训转变研究者观念,完善配套政策和措施,激发研究者承担临床试验的积极性和主动性,壮大研究者队伍;通过搭建临床研究平台,构建长效培训体系和多层次教育体系,稳定临床研究人才梯队;通过开展多学科、跨领域协作,锻炼团队人员专业水平和协作能力,提升我国临床试验研究者团队质量。

Objective:To build a high-quality professional team of clinical research investigators,improve the research capability of investigators,and promote rapid and healthy development of clinical research in China.Methods:By analyzing the problems found in clinical trial inspections and looking for their causes,we put forward the importance and necessity of building a stable,efficient,and high-quality team of clinical researchers,and further explore strategies for enhancing capabilities of the investigator team.Results and Conclusions:Most problems and deficiencies in clinical studies were related to noncompliance of investigators with the Good Clinical Practice(GCP)and their lack of skills in conducting research.We can only fundamentally improve the quality and efficiency of clinical research by strengthening the capabilities of investigators.A principal investigator,as the chief commander of the clinical investigator team,plays a key role in conducting a clinical research and in guaranteeing the quality of the clinical research.The authors suggest providing training for investigators and implementing supportive policies and measures to motivate investigators so that they will be more active and responsible in conducting clinical trials.A long-term training system and a multi-level education system should be established by building a clinical research platform,creating a stable talent team in clinical research;multi-disciplinary and cross-disciplinary collaborations should be carried out to improve the professional and collaboration skills of team members,which will contribute to improving capabilities of clinical research teams in China.