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GE2P2 Global Foundation on behalf of the Global Forum on Research Ethics and Integrity [GFREI] Working Group. (22 September 2023). GFREI Public Consultation Submission: WHO Guidance for Global Practices for Clinical Trials – Draft. (19 July 2023). URL: https://wordpress.com/page/ge2p2-center.net/22742

Curry, D.R., Adiabu, S.,  MPH, Doe Anderson, J., Andrade-Narvaez, F.J., Ang, L., Arawi, T., Aurich, B., DeTora, L., Diniz, N., Gispen-de Wied, C.C., Klein, R., Mahasha, P.W., Pavlov, C.S., Redman, B., Schatz, G.S., Sitorus, R.S., Suzuki, M. as the Global Forum on Research Ethics and Integrity [GFREI] Working Group/GE2P2 Global Foundation. (22 September 2023). GFREI Public Consultation Submission: WHO Guidance for Global Practices for Clinical Trials – Draft. (19 July 2023). URL: https://wordpress.com/page/ge2p2-center.net/22742

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GE2P2 Global Foundation on behalf of the Global Forum on Research Ethics and Integrity [GFREI] Working Group. (22 September 2023). GFREI Public Consultation Submission: WHO Guidance for Global Practices for Clinical Trials – Draft. (19 July 2023). URL: https://wordpress.com/page/ge2p2-center.net/2274
GFREI and GE2P2 Global Public Consultations Working Group Members
Sedem Adiabu, MPH, GE2P2 Global Foundation, USA [2,3,4]
Jestina Doe Anderson, GE2P2 Global Foundation, USA [3]
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]
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]
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]
Richard Klein, Fellow, GE2P2 Global Foundation, USA [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]
Gerald S. Schatz, J.D, USA [1,2,3]
Rita S. Sitorus, MD, PhD, HREC, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Indonesia [3]
Mika Suzuki, MPH, Osaka University, Japan [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 GFREI submission was developed in response to this call for public consultation [World Health Organization. Public consultation on WHO guidance for best practices for clinical trials. 19 July 2023. https://www.who.int/news-room/articles-detail/public-consultation-on-who-guidance-for-best-practices-for-clinical-trials%5D. The submission comprised observations and recommendations around themes and best practice areas including:

• Research Priority Setting
• “Proportionate” design and conduct of trials
• RWD-RWE
• Post-Trial Access
• Compassionate Use/Expanded Access/Managed Access
• Trial populations
• IRBs/RECs as “governance tool”
• Absence of any reference to “assent”
• Assessing the Election to Withdraw or Change Consent; Avoiding Coercion or Undue Influence
• Withdrawing Consent for Use of Trial Data/Samples Already Collected
• WHO Benchmarking Tools
• Novel digital technologies…artificial intelligence
• Human subjects research in conflict zones
• Regulatory capacity, coordination and reliance
• Ethical review and capacity-building
• Benefits Sharing

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

Original Call for Public Consultation
Public consultation on WHO guidance for best practices for clinical trials [accessed 31 October 2023]
WHO – 19 July 2023 54 pages
Call for consultation: Deadline 15 Sep 2023
Overview
In May 2022, the Seventy-fifth World Health Assembly adopted a resolution on Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination, in which one action requested of the Director-General was to develop WHO guidance on best practices for clinical trials. Please see action 2 under section “Requests the Director-General” at the end of WHA 75.8 resolution here. WHO is launching a public consultation on draft guidance developed in line with this request.
We aim to obtain input from all relevant stakeholders, spanning all diseases and health conditions during this consultation, so that these inputs can be taken into account in revision of this draft, following advice from the WHO Technical Advisory Group established to support this process.
Important stakeholder groups for this technical guidance include, (but are not restricted to): public sector researchers, private sector entities engaged in clinical trials, national health authorities or research councils involved in health research, clinical trial registries, research ethics bodies, national or transnational medicinal product regulatory authorities, decision-making bodies making use of evidence such as guidelines developers, and health technology assessment bodies, healthcare practitioners, patient engagement and community engagement entities, and professional associations in disciplines for whom clinical trials of health interventions are relevant. There may also be some relevance to medical journals…