药品真实世界研究场景下的数据合规要求及立法建议

Data Compliance Requirements and Legislative Suggestions in Real Word Research of Pharmaceutical Products

与受试者人群受限、入组标准及诊疗环境严格的传统临床试验相比,真实世界研究是反映临床实际诊疗过程的一类研究,其具有较强的外部代表性,可弱化传统临床试验的限制,数据来源较广,可反映真实世界中临床疗效的特点。真实世界研究的数据来源包括患者、医疗机构、医保部门、药品监管部门、第三方数据库、企业数据库等。这些来源多样的数据形式对开展药品真实世界研究的数据合规提出了新的挑战。本文拟从真实世界研究的法律渊源、涉及数据类型、使用场景及可能涉及数据合规的相关问题进行论述,并就药品真实世界研究场景下的重大数据合规问题提出可能的解决路径与措施。

Real world research is a type of study that reflects the actual clinical treatment process with strong external representation compared to traditional clinical trials with restricted subject populations,strict enrollment criteria and treatment environments.It can weaken the limitations of traditional clinical trials,providing a broader range of data sources,which can reflect the characteristics of clinical efficacy in the real world.The data sources for real world research include patients,medical institutions,health insurance departments,drug regulatory authorities,third-party databases and corporate databases.However,the diverse forms of data from these sources pose new challenges to data compliance in conducting real world research on pharmaceutical products.This paper aims to discuss the legal origins of real world research,the types of data involved,the use scenarios,and the possible data compliance issues.Additionally,it proposes possible solution paths and measures for major data compliance issues in the real world research scenarios of pharmaceutical products.