中医药临床试验受试者招募的影响因素分析

Influencing factors of recruitment of clinical trial subjects in traditional Chinese medicine research and analysis

关键词:  临床试验  受试者招募  中医药  伦理

Key words:  clinical trials  subject recruitment  traditional Chinese medicine  ethic

摘要:

[目的] 受试者招募是药物临床研究中最困难、最具挑战却必不可少的"限速环节"，影响受试者招募的影响因素有很多，包括试验方案、激励措施等，而目前对于中医临床试验受试者招募的资料相对较少。本研究通过问卷调查分析影响中医药临床试验潜在受试者的因素，试图探索中医临床更有效的受试招募手段，为中医药临床受试者招募提供指导。[方法] 对于2018年7月-8月，在北京中医药大学3所三甲医院就诊的400例门诊患者进行问卷调查。[结果] 多因素结果显示，试验方案中的干预措施种类、中医药的毒副作用大小、激励补偿措施、受试者对实施研究医生的信任程度及医院信誉是影响调查对象是否愿意参加试验的主要因素（P<0.05）。[结论] 调查对象对中医药临床试验的认知程度、权利实现以及医患间的信任程度是影响中医药临床受试者招募的主要因素，应通过新媒体等形式向受试者普及相关医学知识、充分保护受试者的权益、增强医生和患者间的沟通等措施对中医药临床试验受试者招募进行完善。

Abstract:

[Objective] Recruitment of subjects is the most difficult and challenging but necessary speed limit in drug clinical research. There are many factors influencing the recruitment of subjects,including trial protocols and incentives. There is relatively little information on the recruitment of traditional Chinese medicine (TCM) clinical trial subjects. This study used questionnaires to analyze the potential factors affecting the subjects of TCM clinical trials,and tried to explore more effective clinical recruitment methods for TCM clinics to provide guidance for the recruitment of TCM clinical subjects.[Methods] For July-August 2018,400 outpatients from three top three hospitals of Beijing University of Chinese Medicine were surveyed.[Results] Multivariate results showed that the trial protocol,the side effects of Chinese medicine,the incentive compensation measures,the degree of trust of the subjects in the implementation of the research doctors and the hospital reputation were the main factors affecting whether the subjects were willing to participate in the trial (P<0.05).[Conclusion] The degree of cognition,the realization of rights and the trust between doctors and patients in the clinical trials of Chinese medicine practitioners are the main factors affecting the recruitment of clinical subjects in Chinese medicine. The relevant medicines should be popularized to the subjects through new media and other forms. Measures to fully recruit the rights of the subjects and enhance communication between doctors and patients to improve the recruitment of clinical trial subjects in Chinese medicine.