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

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Tác giả: Takashi Asakawa, Ryoichi Hanazawa, Akihiro Hirakawa, Ryo Kitabayashi, Hitomi Sumiyoshi Okuma, Ryoto Ozaki, Sho Saito, Hiroyuki Sato, Yosuke Shimizu, Kota Tokushige, Yukari Uemura, Mizuki Yoshida

Ngôn ngữ: eng

Ký hiệu phân loại: 794.147 King

Thông tin xuất bản: United States : Clinical pharmacology and therapeutics , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 188328

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.
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