Background
In May 2022, the World Health Assembly adopted Resolution WHA75.8, “Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination.” The Resolution requested WHO to review existing guidance and develop new global guidance on best practices for clinical trials, including strengthening infrastructure both in normal times and during public health emergencies.
The guidance aims to:
- Support Member States in implementing scientifically and ethically sound clinical trials within their national and regional contexts.
- Guide non-State actors in the design and conduct of trials and in strengthening the global clinical trial ecosystem, particularly for under-represented populations.
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.
The WHO Guidance for Best Practices for Clinical Trials is the key outcome of the Technical Advisory Group’s work, developed in response to the World Health Assembly Resolution WHA75.8 (2022) on strengthening clinical trials. Building on WHO’s previous work on research capacity, the guidance identifies and promotes best practices to enhance clinical research efficiency, minimize research waste, and sustain functional trial systems that can operate effectively in both routine and emergency settings. Drawing on global expertise, it provides a forward-looking framework to support high-quality, inclusive, and ethically sound clinical trials that strengthen research quality, coordination, and equity worldwide. A new Technical Advisory Group on Clinical Research Ecosystem Strengthening was formed to support WHO in strengthening global clinical research ecosystems and advancing implementation of the Guidance for Best Practices for Clinical Trials.
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://www.who.int/about/ethics/declarations-of-interest).
Members
Professor of Epidemiology, School of Public Health, Tehran University of Medical Sciences
Chief Scientific Officer at the Science for Africa Foundation (SFA)
Emeritus Professor of Microbiology, University of Antwerp, Belgium
Maternal and Child Population Health Professor at the National Perinatal Epidemiology Unit at Nuffield Department of Population Health, University of Oxford
Bioethics expert, Head of ICMR Bioethics Unit and the Director of the WHO Collaborating Centre for Strengthening Ethics in Biomedical and Health Research
Clinical Trials Expert
Chief of the Division of Pediatric Infectious Diseases at Stony Brook Children's Hospital, New York
Professor of Health and Social Science Methodology in the Centre for Public Health at Queen’s University Belfast, Northern Ireland
Strategic Partnerships and Capacity Development Manager at the EDCTP (European and Developing Countries Clinical Trials Partnership) office, Cape Town, South Africa
Director of the Tata Memorial Hospital and Professor and Head of Thoracic Surgery at the Tata Memorial Centre, Mumbai, India
Director of the Child and Adolescent Health PhD Program at The University of Melbourne
Professor at the Center of Bioethics, Faculty of Medicine, Clínica Alemana- Universidad del Desarrollo in Santiago, Chile
Chief Executive Officer of Cochrane
Clinical trial expert – Retired
Director of the Department of Obstetrics and Gynecology at Peking University First Hospital
Head of the Biostatistics department at the Centre for the AIDS Programme of Research in South Africa (CAPRISA)