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

European Union Humans Informed Consent Japan Research Personnel Surveys and Questionnaires United States
Clinical trial regulation Good Clinical Practice International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Real-world data Remote monitoring

Journal

Therapeutic innovation & regulatory science
ISSN: 2168-4804
Titre abrégé: Ther Innov Regul Sci
Pays: Switzerland
ID NLM: 101597411

Informations de publication

Date de publication:
03 2022
Historique:
received: 15 09 2021
accepted: 27 10 2021
pubmed: 18 11 2021
medline: 22 3 2022
entrez: 17 11 2021
Statut: ppublish

Résumé

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. For stakeholder engagement in Japan, a designated research group conducted a survey of academic stakeholders. A 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. The 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. The 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.

Sections du résumé

BACKGROUND
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. For stakeholder engagement in Japan, a designated research group conducted a survey of academic stakeholders.
METHODS
A 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.
RESULTS
The 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.
CONCLUSION
The 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.

Identifiants

DOI: 10.1007/s43441-021-00350-4 PMID: 34787814 PMC: PMC8596855
pubmed: 34787814
doi: 10.1007/s43441-021-00350-4
pii: 10.1007/s43441-021-00350-4
pmc: PMC8596855
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

220-229

Informations de copyright

© 2021. The Author(s).

Références

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Integrated Addendum to ICHE6(r1): Guideline for Good Clinical Practice E6(R2). Step 4 version dated 9 November 2016.
Patented Medicine Prices Review Board. Annual Report 2017.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Reflection on “GCP　Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6. https://admin.ich.org/sites/default/files/2021-05/ICH_ReflectionPaper_GCPRenovation_2021_0519.pdf . Accessed 1 July 2021.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Final Concept Paper. ICH E6(R3): Guideline for Good Clinical Practice. https://database.ich.org/sites/default/files/E6-R3_FinalConceptPaper_2019_1117.pdf . Accessed 1 July 2021.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Final Business Plan. ICH E6(R3): Guideline for Good Clinical Practice. https://database.ich.org/sites/default/files/E6-R3_FinalBusinessPlan_2019_1117.pdf . Accessed 1 July 2021.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Summary of Stakeholder Engagement to Support the Development of ICH E6(R3). https://database.ich.org/sites/default/files/E6-R3_PublicEngagemenSummary_2020_0421.pdf . Accessed 1 July 2021.
Corneli A, Forrest A, Swezey T, Lin L, Tenaerts P. Stakeholders’ recommendations for revising Good Clinical Practice. Comtemp Clin Trials Commun. 2021;22:100776.
doi: 10.1016/j.conctc.2021.100776
Clinical Trials Transformation Initiative. Informing the Renovations to the ICH E6 GCP Guideline for Good Clinical Practice. Survey Findings. https://www.ctti-clinicaltrials.org/sites/www.ctti-clinicaltrials.org/files/survey_final.pdf . Accessed 1 July 2021.
U.S. Food & Drug Administration. Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice. Public Web Conference Report. https://www.ctti-clinicaltrials.org/sites/www.ctti-clinicaltrials.org/files/meeting_report_of_key_themes_and_comments_june_2020_-_final_09152020.pdf . Accessed 1 July 2021.
European Medicines Agency. ICH E6(R3) Good Clinical Practice Workshop with Patients’ and Consumers’ (PCWP) and Healthcare Professionals’ (HCPWP) Working Parties. https://www.ema.europa.eu/en/events/ich-e6r3-good-clinical-practice-workshop-patients-consumers-pcwp-healthcare-professionals-hcpwp . Accessed 1 July 2021.
Clinical Trials Transformation Initiative. Informing the Renovations to the ICH E6 GCP Guideline for Good Clinical Practice. In-Depth Interview Findings. https://www.ctti-clinicaltrials.org/sites/www.ctti-clinicaltrials.org/files/idi-report_final_17mar2020.pdf . Accessed 1 July 2021.
Nakamura K, Shibata T. Regulatory changes after the enforcement of the new Clinical Trials Act in Japan. Jpn J Clin Oncol. 2020;50:399–404.
doi: 10.1093/jjco/hyaa028
Fujiwara Y. Evolution of frameworks for expediting access to new drugs in Japan. Nat Rev Drug Discov. 2016;15:293–4.
doi: 10.1038/nrd.2016.68

Auteurs

Kenichi Nakamura (K)

Clinical Research Support Office, National Cancer Center Hospital, Tokyo, Japan. kennakam@ncc.go.jp.
Department of International Clinical Development, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. kennakam@ncc.go.jp.
ORCID: 0000-0003-3534-8296

Hitoshi Ozawa (H)

Clinical Research Support Office, National Cancer Center Hospital, Tokyo, Japan.

Taro Shibata (T)

Clinical Research Support Office, National Cancer Center Hospital, Tokyo, Japan.
Center for Research Administration and Support, National Cancer Center, Tokyo, Japan.

Nobuko Ushirozawa (N)

Clinical Research Support Office, National Cancer Center Hospital, Tokyo, Japan.
Center for Research Administration and Support, National Cancer Center, Tokyo, Japan.

Tomomi Hata (T)

Clinical Research Support Office, National Cancer Center Hospital, Tokyo, Japan.
Department of International Clinical Development, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.

Natsuko Okita (N)

Clinical Research Support Office, National Cancer Center Hospital, Tokyo, Japan.

Nozomu Fuse (N)

Clinical Research Support Office, National Cancer Center Hospital East, Chiba, Japan.

Norihiro Sato (N)

Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Hokkaido, Japan.

Koji Ikeda (K)

Clinical Research, Innovation and Education Center, Tohoku University Hospital, Miyagi, Japan.

Hideki Hanaoka (H)

Clinical Research Centre, Chiba University Hospital, Chiba, Japan.

Tatsuya Maruyama (T)

Clinical Research Support Center, The Tokyo University of Tokyo Hospital, Tokyo, Japan.

Michihiko Wada (M)

Clinical & Translational Research Center, Keio University Hospital, Tokyo, Japan.

Shinobu Shimizu (S)

Department of Advanced Medicine, Nagoya University Hospital, Aichi, Japan.

Hiroi Kasai (H)

Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.

Yoichi Yamamoto (Y)

Department of Medical Innovation, Academic Clinical Research Center, Osaka University Hospital, Osaka, Japan.

Jun Sakurai (J)

Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan.

Koji Todaka (K)

Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.

Shimon Tashiro (S)

Department of Sociology, Graduate School of Arts and Letters, Tohoku University, Miyagi, Japan.

Haruko Yamamoto (H)

Department of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.
Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan.

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