WHO proposes best practices for clinical trials
Posted on the 17th August 2023
The World Health Organization (WHO) has released a preliminary guide outlining key scientific and ethical aspects for well-structured clinical trials.
The guide also proposes methods to enhance the clinical trial framework and improve the participation of underrepresented groups.
It also emphasizes that, while clinical trials are widely recognized as important, the evidence in many health areas remains inadequate due to the absence of well-designed and executed trials.
This deficiency could be attributed to the absence of trials, the failure of conducted trials to produce valid results, or the non-publication of outcomes.
This guide was developed following a decision by the 75th World Health Assembly (WHA). The WHO Director-General solicited public input on defining such a framework during a consultation in October‒November 2022.
The WHO incorporates principles from the International Council for Harmonisation's (ICH) E8 guidance on General Considerations for Clinical Studies and the E6(R3) Good Clinical Practice guidelines.
It also includes recommendations from the Council for International Organizations of Medical Sciences (CIOMS) for clinical research in resource-limited settings and guidance from the Good Clinical Trials Collaborative.
The revised WHO steps include:
- Ensuring well-designed trials that yield scientifically robust answers.
- Employing randomized designs, adequate sample sizes, and unbiased outcome assessments.
- Respecting participants' rights and well-being, combining ethics and scientific validity.
The guideline acknowledges an issue with excessive interpretation of regulations and guidelines, leading to unnecessary trial complexities. To address this, the WHO suggests proportionate trial processes aligned with context and risks, promoting efficient implementation without compromising data quality.
The guide tackles the inclusion of underrepresented populations, stressing the importance of diverse participation. Achieving this involves engaging patients, the public, and communities, while safeguarding rights and well-being.
For instance, the WHO established a framework for including populations with noncommunicable diseases, mental health, and neurological conditions.
The document intends to complement existing universal ethical and scientific standards, focusing on underrepresented groups, without replacing current guidance.
The WHO is now inviting feedback from public sector research agencies, private sector entities involved in trials, national health authorities, research ethics bodies, health technology assessment bodies, healthcare practitioners, and patient/community engagement groups.
The deadline for public input is September 15th.