Technical Advisory Group on Development of Guidance on Best Practices for Clinical Trials
The World Health Assembly Resolution 75.8 “Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination” was adopted by the 75th World Health Assembly in May 2022. The resolution requested that the WHO Secretariat review existing guidance and develop, following the standard WHO processes, new guidance as needed on best practices for clinical trials, including on strengthening the infrastructure needed for clinical trials, to be applied in normal times and with provisions for application during a public health emergency of international concern, considering relevant initiatives and guidelines as appropriate, as appropriate: (a) guidance on best practices to help to guide Member States’ implementation of scientifically and ethically sound clinical trials within their national and regional contexts (b) guidance on best practices for non-State actors in the design and conduct of clinical trials and in strengthening the global clinical trial ecosystem to meet the needs of major population groups that the intervention is intended to benefit, with a particular focus on under-represented populations This advisory group (AG) will advise the Secretariat on the work above.

Operations of the Technical Advisory Group on Development of Guidance on Best Practices for Clinical Trials

The Technical Advisory Group will meet virtually at least three times a year until the guidance is complete. They will assist in drafting and reviewing both draft and final versions of the guidance. The working language for the group is English.

Terms and conditions of appointment to the Technical Advisory Group

Members of WHO advisory groups must be free from conflicts of interest. Applicants must complete the WHO Declaration of Interests, and selection depends on confirming no conflicts or managing any identified conflicts, in addition to WHO’s evaluation of an applicant’s experience, expertise and motivation and other criteria. All AG members serve in an individual expert capacity and do not represent any government, commercial, academic, or other organizations. They are expected to fully comply with the Code of Conduct for WHO Experts (https://covid.comesa.int/about/ethics/declarations-of-interest).

 

Members

Akbar Fotouhi

Professor of Epidemiology, School of Public Health, Tehran University of Medical Sciences

Evelyn Gitau

Chief Scientific Officer at the Science for Africa Foundation (SFA)

Herman Goossens

Emeritus Professor of Microbiology, University of Antwerp, Belgium

Marian Knight

Maternal and Child Population Health Professor at the National Perinatal Epidemiology Unit at Nuffield Department of Population Health, University of Oxford

Roli Mathur

Bioethics expert, Head of ICMR Bioethics Unit and the Director of the WHO Collaborating Centre for Strengthening Ethics in Biomedical and Health Research

Ann Meeker-O’Connell

Clinical Trials Expert

Sharon Nachman

Chief of the Division of Pediatric Infectious Diseases at Stony Brook Children's Hospital, New York

John Norrie

Professor of Health and Social Science Methodology in the Centre for Public Health at Queen’s University Belfast, Northern Ireland

Thomas Nyirenda

Strategic Partnerships and Capacity Development Manager at the EDCTP (European and Developing Countries Clinical Trials Partnership) office, Cape Town, South Africa

C S Pramesh

Director of the Tata Memorial Hospital and Professor and Head of Thoracic Surgery at the Tata Memorial Centre, Mumbai, India

Fiona Russell

Director of the Child and Adolescent Health PhD Program at The University of Melbourne

Sofía P. Salas

Professor at the Center of Bioethics, Faculty of Medicine, Clínica Alemana- Universidad del Desarrollo in Santiago, Chile

Karla Soares-Weiser

Chief Executive Officer of Cochrane

Fergus Sweeney

Clinical trial expert – Retired

Huixia Yang

Director of the Department of Obstetrics and Gynecology at Peking University First Hospital

Nonhlanhla Yende-Zuma

Head of the Biostatistics department at the Centre for the AIDS Programme of Research in South Africa (CAPRISA)