WHO issues draft Guidance on Best Practices for Clinical Trials

Recommendation

4-6 June 2024
Munich, Germany

Qualified Person Education Course Module A PLUS IMP Pre-Course Session
Understand the Implications of becoming a QP

The World Health Organization (WHO) published a draft guideline on best practices for clinical trials. The deadline for comments is 15 September 2023.

Background and Scope

The document is intended to provide guidance to WHO’s Member States and any staff members of non-State actor organizations whose work is related to clinical trials (CTs) in any way, including

• the planning
• conduct 
• analysis
• oversight
• interpretation
• funding

of all CTs in which randomization is used to assess the effects of any health intervention for any purpose in any setting. 

The WHO notes that the ICH efficacy guidelines are a central aspect of the guidance landscape. These include the draft ICH E6(R3) Good Clinical Practice (GCP) guideline and the ICH E8 guideline on General considerations for clinical studies. The proposed WHO document does not supersede any existing guidance. It is meant complementary and intended to support implementation of universal ethical and scientific standards in the context of CTs with a focus on under-represented populations (e.g. children). Moreover, the draft guidance updates and adapts WHO’s previous work on research capacity for the context of CTs. According to the organization, it aims to improve efficiency and minimize research waste, both in normal times and in time of emergency or pandemics. The topics of the document are described in three sections providing high-level guidance on the following:

• Section A includes recommendations for CT design and conduct in order to produce reliably-informative, high-quality evidence 
• Section B contains best practices for the strengthening of the CT ecosystem, including enabling actions
• Section C provides guidance on how CTs can better address evidence needs in under-represented subpopulations, in particular, pregnant and lactating women, infants and children.

These sections are followed by a presentation of recommendations for Member States, research funders and researchers.

More information is available in the announcement Public consultation on WHO guidance for best practices for clinical trials published on The WHO's website.