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WHO’s Clinical Trial Guidance: Same Intent as FDA, With a Twist
(Friday, July 27, 2023) The ICH E6 guidance document and FDA’s clinical trial guidance contain requirements for good clinical trials, but they do not address practical issues related to the conduct of clinical trials particularly in resource-limited and multi-national settings. All locations where trials are being conducted or planned to be conducted are not the same in terms of the available clinical trial ecosystem, patient populations, and clinical relevance. The diversity of the clinical trial ecosystem is not addressed in ICH E6 or related guidance documents. The World Health Organization (WHO) has released a draft guidance that tries to fill those gaps. There are three aspects of clinical trial conduct. First, the scientific and ethical principles for the conduct of clinical trials which are the focus of the ICH E6 guidance document. Second, the clinical trial ecosystem which consists of the infrastructure and resources, and the regulatory review processes that affect the outcome of clinical trials. The clinical trial ecosystem varies between countries and regions. Countries try to address the clinical ecosystem issues by creating country-specific clinical trial guidance that derives heavily from the ICH E6 guidance with some adjustments made for local considerations. The third aspect is equitable representation of all patient populations in clinical trial data. Considerations for clinical trials in resource-limited settings, common in many parts of the world, have not been addressed in any of the existing guidance documents. The WHO guidance discusses these important but often not discussed issues and recommends that the regulators, IRBs, and other oversight bodies consider these during their review of clinical trial design and conduct. The guidance makes recommendations for developing adequate clinical trial ecosystem, accessing diverse patient groups, and generation of data relevant to these diverse clinical populations. The guidance makes five recommendations for establishing best practices for the conduct of clinical trials. First, there should be an adequate clinical trial infrastructure. Efficient high-quality clinical trials require adequate infrastructure, both in terms of physical infrastructure and trial personnel. It is important to use and optimize pre-existing resources and facilities, including those associated with routine health care practice, to facilitate future research. It is not necessary to create new facilities or find new personnel; using/training existing resources is more efficient. Second, trials should be tailored to the context of the location and populations they intend to address. The design and implementation of clinical trials should recognize and be shaped by the characteristics of the settings in which they take place, including the health needs and preferences of communities, their ability to access health care, and their understanding of clinical trials. Relevant and accessible clinical trials are more likely to recruit a sufficient number of trial participants. Third, use existing clinical practices for clinical trial conduct. Clinical trial planning should include making optimal use of pre-existing resources and facilities, including using any expertise, skills, professional standards, and quality oversight mechanisms associated with routine health care practice. For trials conducted in multi-regional setting where clinical practice may vary between different locations participating in the same trial, the variability in standards of care at different sites should be accounted for statistically in the final analysis. Fourth, clinical trials should be subject to sufficient scrutiny to support completion of an informative, ethical, and efficient study and to avoid, correct, or mitigate problems. Effective and efficient governance helps to maintain the scientific and ethical integrity of a trial and to provide advice on appropriate courses of action. This aspect is described in ICH E6 and related guidance documents. And fifth, managing quality effectively and efficiently should be prioritized. The design and conduct of a high-quality trial require competent decision-making and coordinated execution. Good governance and good trial-quality management can help to achieve these features. These project management issues have also been described in ICH E6 and related guidance documents. The WHO guidance is an excellent resource for planners and policymakers as it contextualizes the clinical trial conduct. It connects the existing guidance on clinical trial conduct with practical issues prevalent in the global clinical trial ecosystem to suggest ways to create equitable benefits from clinical trials. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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