08/01/2023
Photo by Brett Zeck on Unsplash
The World Health Organization (WHO) issued a draft guidance for best practices for clinical trials in July 2023. It outlines key scientific and ethical considerations for “good controlled” (also known as well-controlled) trials, guidance on strengthening the clinical trial ecosystem, and addressing underrepresented populations. The draft guidance stems from a resolution the Seventy-fifth World Health Assembly adopted on “Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination.” The resolution requested the development of WHO guidance on best practices for clinical trials (WHA 75.8, action 2 under Requests the Director-General). The draft guidance builds on the WHO’s previous work on research capacity.
The purpose of the draft guidance is to complement existing guidance on good clinical practice to further support universal ethical and scientific standards, with a focus on underrepresented populations. It does not replace existing regulatory requirements or guidance in the individual countries. The WHO is governed by the World Health Assembly (WHA) which includes the WHO’s 194 member states, including the United States.
The draft WHO guidance incorporates elements from ICH E8(R1) and ICH E6(R3) as well as FDA guidance documents, the Council for International Organizations of Medical Sciences (CIOMS) guidelines on clinical research in resource-limited settings from their “International Ethical Guidelines for Health-related Research Involving Humans” and the “Guidance for Good Randomized Clinical Trials” from the Good Clinical Trials Collaborative (references in guidance text).
Best practices include respecting the rights and well-being of the participants, collaboration and transparency, good quality management, and quality by design. The structure in each topic is of a key message and a description of why it is important to follow the recommendation.
The draft guidance stresses that the overinterpretation of regulations and guidance has led to overburdensome study procedures and documentation. Instead, a risk proportionate approach should be used to determine the study procedures that really matter and to ensure the study is operationally feasible. A quality approach focuses on the data that supports safety and efficacy endpoints.
The draft guidance recommends clinical trial personnel training follow a framework for clinical research competency and mentions the “UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases framework.” The framework has four competency domains that encompass the general areas for clinical research skills 1) Scientific thinking, 2) Ethics, quality and risk management, 3) Study and site management, and 4) Research operations. Training in the competencies would depend upon the role.
The public consultation period is open now through September 15, 2023 HERE.
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- The Clinical Pathways Team
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