WHO proposes best practices for clinical trials
The World Health Organization (WHO) has issued a draft guidance spelling out some of the important scientific and ethical considerations for well-designed clinical trials. The document also suggests ways to strengthen the clinical trial ecosystem and touches on improving enrollment of under-represented populations.The guidance notes that “despite the widely recognized importance of clinical trials, in many areas of health the evidence base remains weak, with decision-making processes lacking results from well-designed and well-conducted clinical trials. The reasons may be that clinical trials were never done, or those that were done failed to produce scientifically-robust and clinically-relevant answers or the results were never published.”
The guidance was developed as part of a resolution of the 75th World Health Assembly (WHA). WHO’s Director-General invited public comment on how such an ecosystem should be defined during a public consultation in October‒November 2022.
WHO said the guidance includes the principles of the International Council for Harmonisation’s (ICH) E8 guidance on General Considerations for Clinical Studies and the E6(R3) Good Clinical Practice guidelines. The document also incorporates the Council for International Organizations of Medical Sciences (CIOMS) guidelines on clinical research in resource-limited settings and the guidance from the Good Clinical Trials Collaborative.
Steps to improve clinical trials
WHO said that good clinical trials “are designed to produce scientifically-sound answers to relevant questions.” The design of the trials should be randomized, have an adequate sample size to reduce the impact of random errors, and provide an unbiased assessment of outcomes.
Good clinical trials also respect the rights and well-being of participants. “Ethical clinical trials combine the search for answers to important questions with scientific validity and appropriate protection and respect for all involved, particularly participants.”
The guideline points out that one problematic area has been the “over interpretation of existing regulations and guidance for clinical trials.” This has led to “excessive bureaucracy” which has resulted in “unnecessarily onerous and disproportionate trials procedures.”
To remedy this problem, WHO suggests that “crucially, trial processes should be proportionate to their context and any associated risks, with efficient implementation. Enabling such an approach need not compromise the robustness of the data generated to answer relevant scientific questions; rather it can substantially enhance available evidence from high-quality clinical trials and hence population health worldwide.”
The guidance also addresses how to recruit under-represented subpopulations. It notes that “strenuous efforts need to be made to recruit diverse populations into clinical trials.”
To address this problem, the research community must find ways to include as broad and varied population as possible through “appropriate patient, public and community engagement while safeguarding participants’ rights and welfare, and to find practical ways to do this.”
For example, WHO has created such a framework to include these populations for people living with noncommunicable diseases, and mental health and neurological conditions.
WHO said the document is meant to “complement and support implementation of universal ethical and scientific standards in conducting clinical trials with a focus on under-represented populations” and does not supersede any existing guidance.
The agency requests feedback from public sector research agencies, private sector entities engaged in clinical trials, national health authorities, research ethics bodies, health technology assessment bodies, healthcare practitioners and patient/community engagement entities.
The deadline for public comment is 15 September.
WHO best practice guidance for clinical trials
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