Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation

Kenichi Nakamura,Natsuko Okita,Tatsuya Maruyama,Nozomu Fuse,Shimon Tashiro,Koji Ikeda,Hiroi Kasai,Michihiko Wada,Tomomi Hata,Nobuko Ushirozawa,Jun Sakurai,Shinobu Shimizu,Yoichi Yamamoto,Hitoshi Ozawa,Koji Todaka,Hideki Hanaoka,Norihiro Sato,Haruko Yamamoto,Taro Shibata

doi:10.1007/s43441-021-00350-4

Abstract

BackgroundThe International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is undertaking a major revision of ICH E6 Good Clinical Practice (GCP) decided to involve external stakeholders in ICH-GCP renovation. Activities such as surveys and public conferences have taken place in the United States, European Union, and Japan. For stakeholder engagement in Japan, a designated research group conducted a survey of academic stakeholders.MethodsA total of 105 academic stakeholders from 18 institutions responded to the survey. The research group developed recommendations reflecting the survey results and the opinions from patients and the public.ResultsThe survey showed the top four principles needing renovation were (i) informed consent (Chapter 2.9, 12.4% of respondents believed it needed renovation), (ii) systems for quality assurance (Chapter 2.13, 9.5%), (iii) information on an investigational product (Chapter 2.4, 5.7%), and (iv) procedures on clinical trial information (Chapter 2.10, 5.7%). The top three sections identified as needing renovation were: (i) informed consent (Chapter 4.8, 27.6%), (ii) monitoring (Chapter 5.18, 22.9%), and (iii) composition, functions, and operations of the ethics committee (Chapter 3.2, 14.3%). Recommendations included clarification of ICH-GCP’s scope, proportionality in various aspects of clinical trials, diversity and liquidity of ethics committee members, modernization of informed consent procedures, variations in monitoring, and regulatory grade when using real-world data.ConclusionThe recommendations from Japanese investigators and patients have been submitted to the ICH E6 Expert Working Group, which will strengthen the robustness of the GCP renovation.

Highlights

The E6 Good Clinical Practice (GCP) guidelines issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are widely accepted as a global standard for ensuring the protection of human subjects and reliability in clinical trials of medicinal products [1]
The original ICH-GCP was enacted in 1996. It had not been fully amended for approximately 25 years, an integrated addendum on risk-based monitoring and electronic document management was incorporated as Revision 2 (R2) in 2016
As one of the founding members of ICH, the Japanese MHLW organized this special research group to conduct a survey on ICH-GCP with Japanese academic investigators, hold a public conference, and make recommendations reflecting the opinions from patients and the public

Summary

Introduction

The E6 Good Clinical Practice (GCP) guidelines issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are widely accepted as a global standard for ensuring the protection of human subjects and reliability in clinical trials of medicinal products [1]. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is undertaking a major revision of ICH E6 Good Clinical Practice (GCP) decided to involve external stakeholders in ICH-GCP renovation. Activities such as surveys and public conferences have taken place in the United States, European Union, and Japan. 6.11 Quality Control and Quality Assurance 7.6% 6.12 Ethics 0.0%

Methods

Results

Discussion

Conclusion