Guidance for best practices for clinical trials
WHO, 25 September 2024
Overview [excerpted from WHO announcement and guidance executive summary]
The World Health Organization (WHO) today released guidance to improve the design, conduct and oversight of clinical trials in countries of all income levels. This guidance aims to support stronger country-led research and development (R&D) ecosystems to advance health science so that new, safe and effective health interventions can be made more accessible and affordable globally for people everywhere, faster.
The guidance was developed in response to World Health Assembly resolution WHA 75.8 in an extensive and inclusive process, involving nearly 3000 stakeholders from various sectors across 48 countries. The guidance covers trials for any health intervention, including, but not limited to pharmaceutical medicines; vaccines; diagnostics; nutritional measures; cognitive, behavioural and psychological interventions; preventive care; digital and public health approaches; and traditional or herbal measures.
This document aims to complement other guidance in order to support implementation of universal ethical and scientific standards in the context of clinical trials, with a focus on under-represented populations; it does not represent a legal standard and does not supersede any existing guidance. In particular, this guidance shares many common concepts and principles with guidance produced by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) (5), especially the ICH E8(R1) General Considerations for Clinical Studies guideline (6), (the draft ICH E6(R3) Good Clinical Practice guideline (7), and the ICH E9 statistical principles guideline (8) and its associated addendum (9). In addition, it shares attributes with two further recent guidance documents that were highlighted through WHO’s public consultation process in 2022: those of the Council for International Organizations of Medical Sciences (CIOMS) on clinical research in resource-limited settings (10) and the Good Clinical Trials Collaborative (GCTC) (11).
Both the CIOMS and GCTC guidance have served as sources, with adaptations as needed, for this document. Additional sources highlighted through the consultation include the World Medical Association’s (WMA) Declaration of Helsinki (12) on medical research involving human subjects, the WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks (13) and CIOMS’ International Ethical Guidelines on Health-related Research involving Humans (2016) (14).
Center for Informed Consent Integrity 