::::::::::::

GE2P2 Global Foundation on behalf of the Global Forum on Research Ethics and Integrity [GFREI] Working Group. (05 September 2023). GFREI Public Consultation Submission: ICH E6(R3) GCP  Principles, Annex 1 – Draft. (19 May 2023). URL: https://wordpress.com/page/ge2p2-center.net/22763 FDA Posted Version:

Curry, D.R., Adiabu, S., Andrade-Narvaez, F.J., Ang, L., Asif, F., Arawi, T., Aurich, Bierer, B.E., Collet, M.C., DeTora, L., Diniz, N.M., Gispen-de Wied, C.C., Kang, J.S., Klein, R., Kumar, N.,  Mahasha, P.W., Pavlov, C.S., Redman, B., Ross, G., Schatz, G.S., Sitorus, R.S., as the Global Forum on Research Ethics and Integrity [GFREI] Working Group/GE2P2 Global Foundation. (05 September 2023). GFREI Public Consultation Submission: ICH E6(R3) GCP  Principles, Annex 1 – Draft. (19 May 2023). URL: https://wordpress.com/page/ge2p2-center.net/22763 FDA Posted Version:

::::::::::

:::::::::::

GE2P2 Global Foundation on behalf of the Global Forum on Research Ethics and Integrity [GFREI] Working Group. (05 September 2023). GFREI Public Consultation Submission: WHO Guidance for Global Practices for Clinical Trials – Draft. (19 May 2023). URL: https://wordpress.com/page/ge2p2-center.net/22763 FDA Posted Version:

GFREI and GE2P2 Global Public Consultations Working Group Members
Sedem Adiabu, MPH, GE2P2 Global Foundation, USA [2,3,4]
Fernando J. Andrade-Narvaez, MD, PhD, Autonomous University of Yucatan, Mexico. [2,3]
Professor Lynn Ang, PhD, UCL Institute of Education (IOE), London, UK [2,3]
Farah Asif, MBBS, MSc Clinical Trials, Shaukat Khanum Memorial Cancer Hospital And Research Centre, Lahore, Pakistan
Thalia Arawi, PhD, American University of Beirut & Medical Center, Lebanon [1,2,3]
Dr. Beate Aurich, MRCPCH, Drug Safety Consulting S.A.S.U., France [1,2,3]
David R. Curry, MS, GE2P2 Global Foundation, USA [1,2,3,4]
Barbara E. Bierer, MD, Multi-Regional Clinical Trials Center, Brigham & Women’s Hospital Harvard (MRCT), USA [3]
Mary Catherine Collet, ALS advocate, USA [2,3]
Lisa DeTora, PhD, Hofstra University, USA [1,3]
Prof. Nilza Maria Diniz, State University of Londrina-UEL, Brazil [2,3]
Christine C. Gispen-de Wied, MD, independent regulatory consultant, Gispen4RegulatoryScience, the Netherlands [1,2,3]
Jane S. Kang, MD, MS, Columbia University Medical Center, USA [1,2,3]
Richard Klein, Fellow, GE2P2 Global Foundation, USA [2,3]
Dr. Nandini K. Kumar, Forum for Ethics Review Committees in India (FERCI), India [1,2,3]
Phetole W Mahasha, PhD, South African Medical Research Council, South Africa [1,2,3]
Prof. Chavdar S. Pavlov, First Moscow State Medical University named after I.M. Sechenov, Botkin Hospital, Russia [2,3]
Barbara Redman, PhD, MBE, Senior Fellow, GE2P2 Global Foundation, USA [1,2,3]
Gloria Ross, MBE, National Research Ethics Board of Liberia, Liberia [1.2.3]
Gerald S. Schatz, J.D, USA [1,2,3]
Rita S. Sitorus, MD, PhD, HREC, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Indonesia [1,3]
Yeyang Su, PhD, Hangzhou Institute of Medicine, Chinese Academy of Sciences., China [2,3]
[1] Contributed written comments/text edits to submission
[2] Participated in WG calls involving draft guidance assessment/discussion/debate
[3] Reviewed/endorsed final submission
[4] Member of GFREI-GE2P2 Global Secretariat responsible for aggregation/editing/final submission

Abstract:
The GE2P2 Global-GFREI Public Consultations Working Group convened weekly calls in July and August 2023 to review and debate various issues and possible solutions identified in the ICH E6(R3) draft. The Secretariat aggregated, integrated and refined a submission working draft reflecting these calls and specific written submissions by WG members. This working draft was then circulated to the full membership of the GE2P2 Global Foundation and Global Forum for Research Ethics and Integrity [GFREI] [100+ individuals in over 30 countries] for final comments and endorsement.
The submission leads with general comments concerning the draft guidance overall, followed by specific observations on line-level text with suggestions for edits/new language in most cases. We intend these comments as needed clarification and emphasis of existing regulations that ICH seeks to harmonize.
The submission comprised observations and recommendations around themes and best practice areas including but not limited to:

• Assent
• Post-Trial Access
• Research Priority Setting
• Compassionate Use/Expanded Access/Managed Access
• Benefits Sharing
• Continuing IRB/REC Trial Oversight
• Posting of Trial Documentation including ICFs
• Transparency on IRB/REC Experts/Non-Members
• Withdrawal from Trial – Information Gathering/Impartial Witnesses
• Re-consenting triggers – New Information
• Coercion/Undue Influence on Trial Participants
• Transfer of Trial Records upon Merger/Change in Control

Final Published Version
Full citation of final version of guidance [when issued].

Original Call for Public Consultation
Public Consultation: ICH E6(R3) [GCP] Principles, Annex 1 and Annex 2
ICH – The E6(R3) EWG is working on the revision of the E6(R2) Guideline “Good Clinical Practice” (GCP).
The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities.
This guideline builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies. This includes fostering a quality culture and proactively designing quality into clinical trials and drug development planning, identifying factors critical to trial quality, and 14 engaging stakeholders, as appropriate, using a proportionate risk-based approach.
Clinical trials vary widely in scale, complexity and cost. Careful evaluation of the priorities involved in each trial and the risks associated with the priorities will help ensure efficiency by focusing on activities critical to achieving the trial objectives.
…[This draft]:
:: Addresses application of GCP principles to the increasingly diverse trial types and data sources being employed
:: Support decision-making [regulatory and healthcare-related on drugs
:: Provide flexibility whenever appropriate to facilitate use of technological innovations in clinical trials
Draft presented for public consultation: . E6(R3) Draft Guideline [accessed 03 Nov 2023]