Summary Report of a Public Workshop: Case Studies of Multi‐Regional Clinical Trial Incorporating Concept of the ICH E17 Guideline-Reference-Cited by-同舟云学术

Summary Report of a Public Workshop: Case Studies of Multi‐Regional Clinical Trial Incorporating Concept of the ICH E17 Guideline

Published:2024-01-22 Issue: Volume: Page:
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Matsushima Nobuko¹²^ORCID,Otsubo Yasuto³,Aoi Yoko⁴,Nakamura Ryuta⁵,Kaneko Shuhei²⁶,Asakawa Takashi²⁷,Matsuoka Nobushige²⁸,Watabe Kei²⁹,Komiyama Osamu²⁸,Yamamoto Hideharu²⁷,Ando Yuki¹⁰

Affiliation:

1. Clinical Pharmacology & Pharmacometrics, Global R&D, Janssen Pharmaceutical K.K. Tokyo Japan

2. Data Science Expert Committee, Drug Evaluation Committee Japan Pharmaceutical Manufacturers Association Tokyo Japan

3. Office of New Drug II Pharmaceuticals and Medical Devices Agency Tokyo Japan

4. Office of New Drug V Pharmaceuticals and Medical Devices Agency Tokyo Japan

5. Office of New Drug I Pharmaceuticals and Medical Devices Agency Tokyo Japan

6. Biostatistics Pharma, Global Drug Development Division Analytics and Clinical Development Management Japan, Novartis Pharma K.K. Tokyo Japan

7. Biometrics Department Chugai Pharmaceutical Co., Ltd. Tokyo Japan

8. Biometrics & Data Management, Pfizer R&D Japan Tokyo Japan

9. Data Science, Drug Development Division Sumitomo Pharma Co., Ltd. Tokyo Japan

10. Biostatistics Group, Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency Tokyo Japan

Abstract

To further our understanding of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E17 guideline and promote effective implementation, a public workshop was held in Japan by regulatory agency and industry representatives. In this workshop, important concepts explained in the ICH E17 guideline, such as intrinsic/extrinsic ethnic factors that influence treatment effects (“effect modifiers”) and the holistic evaluation of consistency of treatment effect were actively discussed through case studies. The importance of holistic evaluation of consistency was recognized, and it was concluded that the evaluation and relevant discussion should be shared with regulatory authorities, sponsors, and broader stakeholders.

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.3163

Reference17 articles.

1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.ICH harmonised guideline: General principles for planning and design of multi‐regional clinical trials E17 (final version). (2017). Accessed 20 July 2023.

2. Pharmaceuticals and Medical Devices Agency.Review report: Verquvo tablets 2.5 mg Verquvo tablets 5 mg Verquvo tablets 10 mg. (2021). Accessed 20 July 2023.

3. Pharmaceuticals and Medical Devices Agency.Review report: Kerendia tablets 10 mg Kerendia tablets 20 mg. (2022). Accessed 11 December 2023.

4. Evaluation of data for multi‐regional trials: a three‐layer approach;Komiyama O.;Appl. Clin. Trials,2013

5. Improvement of Signs and Symptoms of Nonradiographic Axial Spondyloarthritis in Patients Treated With Secukinumab: Primary Results of a Randomized, Placebo‐Controlled Phase III Study