定性和混合方法研究在患者参与药物研发中的应用

The application of qualitative research and mixed methods research in patient involvement in drug development

患者参与药物研发是以患者为中心的药物研发的重要组成部分,其价值已得到国际上医药科技领先国家和地区的认可并在积极探索其实施。我国国家药品监督管理局药品审评中心自2021年11月以来,已发布6个相关指导原则或征求意见稿。患者通过全程、深度参与药物研发整个生命周期,及时提供意见和反馈信息,而这些信息的收集和分析需要科学的研究方法保证患者数据的质量和结果报告的严谨性、透明性。定性或混合方法研究正是适用于患者开放式反馈信息收集、分析和报告的科学研究方法。但是这2种方法在以定量为主导的药物研发领域尚不被广泛认识,因此本文将对这2种方法及其在患者参与药物研发中的应用做简要介绍,以期业内人士能应用科学方法提高患者参与药物研发的质量。

Patient engagement in drug development is a vital part of patient-centered drug development,and its value and implementation have been recognized and actively explored by leading countries or regions in the field of medicine all over the world.Since November 2021,the Center for Drug Evaluation has issued six guidelines or drafts for patient-centered drug development.Patients provide suggestions and feedback in time through deep participating in the drug development,while collecting and analyzing the information require scientific research methods to ensure the quality of patient data and the rigor and transparency of reports.Qualitative or mixed-methods research is a scientific research method suitable for patients open information collection,analysis,and reporting.However,these two methods may not be widely recognized in the field of drug development.Therefore,this paper briefly introduces these two methods and their application in patient involvement in drug development,aiming to improve the quality of related research.