Overview
This event will be conducted online via Zoom.
Simultaneous Japanese/English interpretation available.
In recent years, various innovations have been applied in the development of medical technologies which have had significant impact. New technologies have helped boost productivity and reduce development time and costs.
Such trends have also been seen in the healthcare industry, and, together with the additional impact of the COVID-19 pandemic, we are witnessing growing use of new technologies and new methods in drug development.
DIA Japan has established workshops focused on the latest technologies supporting innovation in this environment under its recent hot-topic “Cutting Edge Series.” The Master Protocol was selected as the latest method to improve clinical trial efficiency as Part 2 of this “Cutting Edge Series.”
In this environment, addressing critical clinical issues while reducing costs remains challenging. In recent years, complex clinical studies (using basket, umbrella, and platform designs) have been conducted with mainly great results in Europe and the US; for example, I-SPY 2, EPAD, DIAN-TU, GBM AGILE, etc. The MASTER KEY Project, adopting a method of simultaneously conducting multiple clinical trials with accumulating rare cancer registry data, has been conducted in Japan. These studies have been useful in exploring and validating common disease characteristics.
This “Master Protocol Workshop” was designed to not only help prepare Master Protocols but to share knowledge and discuss issues essential to conducting basket, umbrella and other complex clinical trials. Through case studies, we will introduce and explain differences in regulations between Japan, the US and Europe; issues and considerations when conducting complex clinical trials; and how to evaluate the results of multiple clinical trials. We will also discuss the challenges and expectations for promoting complex clinical trials among industry, regulators, and other experts in Japan.
We sincerely await your participation.
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Program Committee
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Akihiro Hirakawa, PhD Professor,Clinical Biostatistics,Graduate School of Medical and Dental Sciences
Tokyo Medical and Dental University, Japan -
Morihiko Hayashi, DVM Clinical Development, Clinical Science & Strategy
Chugai Pharmaceutical Co., Ltd., Japan -
Toshinori Higashi, PhD Vice President, Regulatory Science
KAKEN PHARMACEUTICAL CO.,LTD., Japan -
Masakazu Hirata, MD, PhD Clinical Reviewer, Division of RS Consultation, Kansai Branch
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
Akiko Okamoto, DrSc Senior Director, Global Head of Clinical Biostatistics for Neuroscience
Janssen R&D, Johnson & Johnson, United States -
Hitomi Okuma, MD, PhD Head, International Research and Development Section
National Cancer Center Hospital, Japan -
Akiko Ikeda, RPh
KalVista Pharmaceuticals Japan K.K., Japan -
Atsushi Tsukamoto, PhD, MSc Head is Therapeutic Area Strategies
Daiichi Sankyo, United States
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