论文部分内容阅读
为进一步促进药物流行病学研究的规范化,满足当前研究实践的需要,国际药物流行病学学会于2015年6月发布了新版《规范药物流行病学研究指南(Guidelines for Good Pharmacoepidemiology Practice,GPP)》。新版GPP涵盖研究方案制定,责任、人员、设施、资源投入和合同各方,研究实施,信息发布,不良事件报告和文件归档等多个方面的内容。与旧版相比,新版GPP的应用范围更广,并可为研究过程中涉及到的研究方案注册、伦理诚信和不良事件报告等提供更加全面的指导。对新版GPP的主要内容及变化进行解读,可为我国开展规范化的药物流行病学研究提供有益的借鉴。
In order to further promote the standardization of epidemiological research and meet the needs of current research practice, the International Institute of Pharmaceutical Epidemiology released a new version of the Guidelines for Good Pharmacoepidemiology Practice (GPP) in June 2015 . The new version of GPP covers research programs, responsibilities, personnel, facilities, resources inputs and contracting parties, research implementation, information dissemination, adverse event reporting and document archiving. Compared with the old version, the new version of GPP is more widely used and can provide more comprehensive guidance on the registration of research programs, ethical integrity and adverse event reports involved in the research process. Interpretation of the main content and changes of the new version of GPP can provide useful reference for our country to carry out standardized pharmacoepidemiology research.