Harmonization by Doing Proposal for Global Clinical Trial Designs for Endovascular Devices for Treatment of Critical Limb Ischemia: The United States Food and Drug Administration Perspective　― Reply ―

We appreciate Drs. Cavanaugh, Buckley and Malone for their letter commenting on our report entitled “Design Strategies for Global Clinical Trials of Endovascular Devices for Critical Limb Ischemia (CLI): A Joint USA-Japanese Perspective”.¹ Because CLI patients’ backgrounds vary greatly and the medical devices are also diverse, we think that it is better to evaluate the effectiveness and safety of endovascular devices for treatment of CLI using randomized controlled trials initially. However, we also think that it is very important to conduct clinical trials efficiently, so if clinical evidence accumulates, single-arm studies will be more accepted for evaluating a device’s performance. For that purpose, we believe that the framework of HBD will enable these discussions with industry, regulators and academia in both Japan and the USA. We also hope that USA-Japan joint global clinical trials based on our basic concept will be carried out by many medical device companies in both countries in order to accelerate device development for CLI.

• Hiroyoshi Yokoi, MD
• Mami Ho, MD
• Shin Iwamoto, PhD
• (on behalf of the authors)
• Department of Cardiovascular Medicine,
• Fukuoka Sanno Hospital, Fukuoka (H.Y.);
• Office of Medical Devices III (M.H.),
• Office of Medical Devices II (S.I.),
• Pharmaceuticals and Medical Devices Agency, Tokyo, Japan

Reference

• 1.   Yokoi H, Ho M, Iwamoto S, Suzuki Y, Ansel GM, Azuma N, et al. Design strategies for global clinical trials of endovascular devices for critical limb ischemia (CLI): A joint USA-Japanese perspective. Circ J 2018; 82: 2233–2239.