临床试验质量保障关键因素之一--中国临床研究协调员的职业倦怠现象浅析

Review of Job Burnout among Chinese Clinical Research Coordinators--Key Factor Affecting Quality Assurance for Clinical Trials

背景:临床研究协调员(CRC)作为临床试验质量保障的关键因素之一,其专业能力及工作态度影响临床试验的质量。然而,由于工作环境、行业定位、工作形式等多种因素导致CRC职业团体产生了严重的职业倦怠。目的:通过对不同类别的CRC从业人群的职业倦怠比例及倦怠产生原因进行研究,为CRC管理提供可参考性依据,保障现场管理组织(SMO)的稳定和发展,保证临床研究项目的质量和进度,为行业发展提供可参考的依据。方法:本研究采取问卷调查的方式,评价CRC工作倦怠情况。结果:通过“问卷星”调查方式,共收到有效问卷1730份,职业倦怠比例超过60%。分析职业倦怠的影响因素,行业前景不看好或不确定产生职业倦怠比例最高。正在经历职业倦怠的CRC人群中,有50%以上的CRC认为“工作负荷大、节奏快、要求高;付出与回报不成正比;内心期望与现实冲突”是造成CRC职业倦怠的主要影响因素。结论:在这个尚未成熟的新职业领域,由于多种影响因素,CRC职业倦怠比例相对偏高。如何改善CRC职业倦怠偏高现象,需要监管部门、临床试验机构、制药企业、合同研究组织(CRO)以及SMO携手努力,从制定行业规范、提高CRC专业素养、加强医药行业对于CRC的职业认同感、改善CRC薪酬待遇等多方面着手。

Background:As one of the key factors affecting quality assurance for clinical trials,the professional competence and work attitude of clinical research coordinators(CRC)could greatly affect the quality of clinical trials.However,due to various factors such as working environment,professional requirements and work pattern,serious job burnout is reported among CRCs.Objective:Through research on the proportion and causes of job burnout among different CRC groups,this article aims to provide insights and evidence for CRC management,so as to further ensure the stability and development of site management organization(SMO),as well as the quality and progress of clinical research projects.Methods:This research conducts a questionnaire survey to evaluate job burnout among CRCs.Results:The questionnaire survey is constructed using Questionnaire Star.A total of 1730 valid questionnaires were collated,in which over 60%of the respondents reported job burnout.According to analysis on the causes of job burnout,a pessimistic or uncertain view of the career prospect is most common.More than 50%of CRCs experiencing burnout believe that“heavy workload,fast-paced work,high requirements,effort-reward imbalance,and unmet expectations”are the main factors causing job burnout.Conclusion:In a new career path that is not yet fully developed and affected by various factors,CRCs experience relatively high burnout.To address this problem,regulatory departments,clinical trial institutions,pharmaceutical companies,contract research organizations(CRO)and SMOs need to work together to formulate industry standards,enhance CRCs’professional qualities,give greater professional recognition to CRCs,and improve their salary,etc.