新药临床开发过程中性别差异影响的考虑和研究策略

Considerations and research strategies on the assessment of gender difference in the clinical development of new drugs

性别差异是导致药物有效性、安全性出现个体差异的重要因素之一。随着临床医学进入精准医疗时代,更加强调个体化用药。为实现这一目标,在药物开发的起始阶段,就需要对包括性别差异在内的影响因素进行研究、分析和评价。必要时,制定差异化的给药方案。本文总结了造成药物响应出现性别差异的内在和外在因素、女性参加临床试验的情况以及在新药临床试验中如何进行性别差异的分析和判断,旨在为药物的上市、研究与评价、完善说明书、药物的个体化治疗提供支持。

Gender difference is one of the factors affecting individual＇s response to drugs. As clinical medicine entering the era of precise medication,more efforts are focused on individualized therapy. To fulfill this goal,we need to investigate,analyze and evaluate the influences of various factors including gender difference at the beginning of clinical development of new drugs,and construct individualized dosage regimen when necessary. In this paper,we summarized the internal and external factors causing gender difference of individual＇s response to drugs,the participation of women with childbearing potential in clinical trials,as well as the analysis and judgment of gender difference in clinical study of new drugs. The aim is to provide evidences for the marketing authorization,study and evaluation,refining labels,and individualized use of new drugs.