多囊卵巢综合征不孕症临床试验偏离方案情况分析及应对策略

Analysis of the Deviation of Clinical Trials of Polycystic Ovary Syndrome Infertility and its Coping Strategies

药物临床试验设计和实施应遵循临床试验管理规范及标准操作规程的相关要求,尽可能减少试验中偏离方案和违反方案的发生,但在实施过程中偏离试验方案却难以避免。介绍方案偏离的定义及分类,认为常见的原因多来源于受试者因素、研究者因素、试验组织者因素,偏离方案的轻重将对研究结果产生不同程度的影响。以多囊卵巢综合征不孕症中医药临床研究为例,对试验过程中偏离方案的基本情况进行分析,提出解决策略,以期为提升中医临床试验研究质量提供思路。

The design and implementation of drug clinical trials should follow the relevant requirements of clinical trial management norms and standard operating procedures,minimize the occurrence of deviations and violations in the trial,but it is difficult to avoid deviation from the experimental scheme during the implementation process.This paper introduced the definition and classification of program deviations.It is believed that the common causes are mostly from the subject factors,the researcher factors,and the trial organizer factors.The weight of the deviation scheme will have different effects on the research results.Taking the clinical research on traditional Chinese medicine(TCM)infertility in polycystic ovary syndrome as an example,the basic situation of the deviation program in the test process was analyzed,and the solution strategy was proposed to provide ideas for improving the quality of TCM clinical trial research.