临床试验第三方招募公司现状分析及伦理管理的对策研究

Analysis on the Current Situation of Third-party Recruitment Companies in Clinical Trials and Research on Ethical Management Countermeasures

目的第三方研究参与者招募公司及其招募业务方兴未艾,研究分析其公司建设、临床试验应用和伦理审查现状,讨论并结合工作经验提出伦理管理建议。方法通过问卷调查某院2年来伦理委员会批准立项的项目相关研究参与者招募情况,了解掌握和挖掘分析第三方招募公司在建设、应用和伦理审查方面的数据。结果调研发现了第三方招募公司在临床试验应用、公司自身建设和伦理审查规范化方面存在的问题,并结合工作经验剖析了问题的现象与成因。结论第三方招募公司的应用越来越广泛,当前尚处于利弊参半状态,需要各方共同努力,进一步进行规范和约束,以保护研究参与者权益,有效支撑临床试验研究。

Objective:Third-party research participants recruitment companies and their recruitment businesses are in the ascendant.To analyze the current situation of company construction,clinical trial application,and ethical review,and discuss and propose ethical management suggestions based on work experience.Methods:The recruitment of research participants related to the projects approved by the ethics committee in our hospital in the past two years was investigated by questionnaire to comprehend and analyze the data of the third-party recruitment company in construction,application,and ethical review.Results:This paper found the problems of the third-party recruitment company in the application of clinical trials,the company's own construction,and the standardization of ethical review,and analyzed the phenomenon and causes of the problems based on work experience.Conclusion:Although the application of third-party recruitment companies is becoming more and more extensive,it is still in a mixed state of pros and cons.It is necessary for all parties to work together to further standardize and constrain them,so as to protect the rights and interests of research participants and effectively support clinical trial research.