Planning and Implementing Master Protocol Trials in Japan: Key Considerations of the Japanese Guideline.

Autor: Hirakawa A; Department of Clinical Biostatistics, Graduate School of Medical and Dental Sciences, Institute of Science Tokyo, Tokyo, Japan., Asakawa T; Biometrics Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan., Tokushige K; Advanced Quantitative Sciences, Development Japan, Novartis Pharma K.K., Tokyo, Japan., Ozaki R; Biometrics Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan., Yoshida M; Department of Biometrics & Data Management, Development Japan, Pfizer R&D Japan G.K., Tokyo, Japan., Okuma HS; Department of Medical Oncology, National Cancer Center Hospital, Tokyo, Japan., Saito S; Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan., Shimizu Y; Biostatistics Section, Department of Data Sciences, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan., Kitabayashi R; Department of Clinical Biostatistics, Graduate School of Medical and Dental Sciences, Institute of Science Tokyo, Tokyo, Japan., Hanazawa R; Department of Clinical Biostatistics, Graduate School of Medical and Dental Sciences, Institute of Science Tokyo, Tokyo, Japan., Sato H; Department of Clinical Biostatistics, Graduate School of Medical and Dental Sciences, Institute of Science Tokyo, Tokyo, Japan., Uemura Y; Biostatistics Section, Department of Data Sciences, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.
Jazyk: angličtina
Zdroj: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2024 Nov 22. Date of Electronic Publication: 2024 Nov 22.
DOI: 10.1002/cpt.3508
Abstrakt: The importance of master protocol trials, which encompass basket, umbrella, and platform trials, has been increasingly recognized worldwide for their efficiency in evaluating multiple drugs or diseases within a single trial. While the US Food and Drug Administration and European regulatory bodies have issued guidelines to facilitate such trials, Japan only recently introduced its own set of guidelines to address the unique challenges and opportunities within its regulatory and healthcare landscape. Our study elaborates on these newly issued Japanese guidelines, which were developed through a collaborative effort involving biostatisticians, physicians, clinical trialists, regulatory authorities, and industry representatives. We provide a comprehensive overview of the guidelines, emphasizing their structure, content, and key considerations for effective planning and implementation. By highlighting the specific adaptations and innovations required to conduct master protocol trials in Japan, we aim to contribute to the broader discourse on optimizing clinical trial frameworks and enhancing drug development efficiency.
(© 2024 The Author(s). Clinical Pharmacology & Therapeutics © 2024 American Society for Clinical Pharmacology and Therapeutics.)
Databáze: MEDLINE
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