Study design recommendations in guidance documents for high-risk medical devices. A systematic review.d

This review is one of the tasks in the Horizon 2020 project Coordinating Research and Evidence for Medical Devices (CORE-MD), which started in April 2021 and will end in March 2024 (https://www.core-md.eu). Its mission is "Translating expert knowledge into advice for EU regulatory guidance and building expertise in regulatory science in the clinical community".

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The objectives of this systematic review are firstly to identify guidance on the design, conduct, analysis, and reporting of confirmatory pivotal clinical trials and other clinical investigations for high-risk medical devices, from regulators, international standardization organizations, medical professional associations, academic consortia, and HTA agencies; secondly, to compare their similarities and differences; and thirdly, to identify gaps for further research on trial methodology.

本评价报告为“协调医疗设备研究和证据”（Horizon 2020项目Coordinating Research and Evidence for Medical Devices，简称CORE-MD）中的一项任务，该项目自2021年4月启动，预计于2024年3月结束（https://www.core-md.eu）。其使命在于‘将专家知识转化为欧盟监管指南的建议，并在临床社区中构建监管科学的专业知识’。

本作品采用Creative Commons Attribution 4.0国际许可协议。欲查阅该许可协议副本，请访问http://creativecommons.org/licenses/by/4.0/或致信Creative Commons，地址：PO Box 1866, Mountain View, CA 94042, USA。

本次系统评价的目标首先是从监管机构、国际标准化组织、医学专业协会、学术联盟和健康技术评估机构中识别关于高风险医疗设备的设计、实施、分析和报告验证性关键临床试验及其他临床研究的指南；其次，比较这些指南的异同；最后，识别关于试验方法进一步研究的空白领域。