FDA：《医疗器械临床研究中年龄、人种及种.docxVIP

Evaluation and Reporting of Age,Race, and Ethnicity Data inMedical Device Clinical Studies医疗器械临床试验关于年龄、人种和种族的评价和报告Draft Guidance for Industry andFood and Drug Administration Staff企业和食药管理人员指导草案U.S. Department of Health and Human Services 美国健康和人类服务部Food and Drug Administration 美国食品和药品监督管理局Center for Devices and Radiological Health 器械和放射健康中心Center for Biologics Evaluation and Research生物制剂评价和研究中心Ⅰ.Introduction引言The purpose of this guidance is to outline the FDA’s expectations and provide recommendations for the evaluation and reporting of age, race and ethnicity data in medical device clinical studies. The primary intent of these recommendations is to improve the quality, consistency and transparency of data regarding the performance of medical devices within specific age, race, and ethnic groups. Proper evaluation and reporting of this data can benefit patients, clinicians, researchers, regulators and others. Additionally, it is important that clinical trials include diverse populations that reflect the intended use population. In general, to achieve an unbiased estimate of treatment effect in the general population, sponsors should develop a strategy to enroll diverse populations including representative proportions of relevant age, race, and ethnicity subgroups, which are consistent with the intended use population of the device. This draft guidance includes recommendations and considerations to assist sponsors in developing such a strategy. 该指导文件的目的是概述FDA的期望，为评价和报告医疗器械临床试验关于年龄、人种和种族方面提供建议。这些建议的主要意图是的提高关于医疗器械在特定年龄、人种和种族的性能实验数据的质量、稳定性和透明性。合理的评价和报告数据有益于病人、临床医生、研究人员和监管部门等等。另外，包含不同人群的临床试验是很重要的，影响到医疗器械的特定适用目标人群。一般来讲，为了验证治疗效果在普通人群中没有偏差，临床试验申请者应该制定一个方案，入组人员应包含代表相关年龄、人种和亚种族的不同比例人群，要与器械的目标人群相一致。该指导草案包含了辅助申办者制定试验方案的建议和注意事项。When finalized, this guidance will extend the policy set forth in the FDA’s Evaluation of Sex- Specific Data in Medical Device Clinical Studies Guidance1 to additional demographic subgroups of age, race, and ethnicity. FDA intends to integrate the final cont