Office of Medical Devices Policy, Policy Planning Division for Pharmaceutical Industry Promotion and Medical Information Management, Health Policy Bureau, Ministry of Health, Labour, and Welfare, Chiyoda-ku, Tokyo 100-8916, Japan.
Office of Health Technology II: Cardiovascular Devices, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD 20993, USA.
Cardiovasc Revasc Med. 2023 Jul;52:67-74. doi: 10.1016/j.carrev.2023.02.015. Epub 2023 Feb 24.
As medical device development becomes increasingly global, the opportunities and potential advantages offered by international clinical trial and regulatory approval strategies are also growing. In particular, medical device clinical trials involving sites in both the United States and Japan and intended to support marketing in both countries may warrant particular consideration, given the similarities in their regulatory systems, patients and clinical practice patterns, and market sizes. Since 2003, the US-Japan Harmonization By Doing (HBD) initiative has been focused on identifying and addressing clinical and regulatory barriers to medical devices access in both countries via collaboration between governmental, academic, and industry stakeholders. Through the efforts of HBD participants, US-Japanese clinical trials have been conducted and the resulting data have supported regulatory approval for marketing in both countries. Based on these experiences, this paper outlines some of the key factors to consider when developing a global clinical trial involving US and Japanese participation. These considerations include the mechanisms for consultation with regulatory authorities on clinical trial strategies, the regulatory framework for clinical trial notification and approval, recruitment and conduct of clinical sites, and lessons learned from specific US-Japanese clinical trial experiences. The goal of this paper is to promote global access to promising medical technologies by assisting potential clinical trial sponsors in understanding when an international strategy may be appropriate and successful.
随着医疗器械开发变得越来越全球化，国际临床试验和监管审批策略所提供的机会和潜在优势也在不断增加。特别是，涉及美国和日本的临床试验站点，并旨在支持两国的市场推广的医疗器械临床试验，可能需要特别考虑，因为它们的监管体系、患者和临床实践模式以及市场规模相似。自 2003 年以来，美国-日本通过合作来实现协调（HBD）倡议一直致力于通过政府、学术和行业利益相关者之间的合作，确定和解决两国医疗器械准入的临床和监管障碍。通过 HBD 参与者的努力，已经进行了美日临床试验，并且由此产生的数据支持了在两国的市场推广的监管批准。基于这些经验，本文概述了在制定涉及美国和日本参与的全球临床试验时需要考虑的一些关键因素。这些考虑因素包括就临床试验策略与监管机构进行咨询的机制、临床试验通知和批准的监管框架、临床试验站点的招募和实施，以及从具体的美日临床试验经验中吸取的教训。本文的目标是通过帮助潜在的临床试验赞助商了解何时采用国际策略可能是合适和成功的，来促进有前途的医疗技术的全球准入。
