Patient Registry System and Its Application of Supporting Drugs and Medical Devices Regulation
WANG Xue1, YANG Yue1,2*
1. School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China; 2. School of Pharmaceutical Sciences, Tsinghua University, Beijing 100084, China
Abstract:OBJECTIVE To review the development process of the patient registries, summarize and analyze its key elements and explain the design steps of patient registration research and its application in regulatory decision-making, put forward reasonable suggestions for promoting the application of patient registries in Chinese regulatory decision-making. METHODS Based on domestic and foreign literature research method, from the two aspects of pre-marketing drug device clinical evaluation and post-marketing monitoring, this paper clarified the key issues that need to be considered in patient registries and application. RESULTS Patient registration can be used to support regulatory decision-making, for example, to evaluate the natural history of a disease; determine the clinical effect, cost-effectiveness, or relative effectiveness of a trial or treatment; measure or monitor the safety and effectiveness of specific products. CONCLUSION In some cases, the use of patient registration as an evidence development tool can fill the gap between clinical trial results and actual clinical practice, but its application in China still has shortcomings. Therefore, it is necessary to strengthen the construction of data collection and analysis infrastructure and improve the communication and review mechanism for patient registries studies is crucial.
王雪, 杨悦. 患者登记系统及其在药械监管中的应用研究[J]. 中国药学杂志, 2021, 56(9): 762-769.
WANG Xue, YANG Yue. Patient Registry System and Its Application of Supporting Drugs and Medical Devices Regulation. Chinese Pharmaceutical Journal, 2021, 56(9): 762-769.
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