As subjects in drug clinical trials and participants in medical practice,patients can best understand their own conditions and needs.With this in mind,the FDA proposed"patient-centered drug discovery"and issued a set of guidelines to incorporate patient experiences,perspectives,needs,and preferences into the drug development and evaluation process.Guideline(2),methods for identifying important patient information,mainly describes methods and precautions for collecting and extracting patient experience data.This paper will focus on the characteristics,common methods and precautions of qualitative,quantitative and mixed research methods in the collection of patient experience data,in order to provide help for the comprehensive collection of patient experience data.
关键词
以患者为中心药物研发/患者体验数据/定性研究/定量研究/混合研究
Key words
Patient-focused drug development/Patient experience data/Qualitative research methods/Quantitative research methods/Mixed research methods