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WHO in midst of forming group focused on developing guidance on best practices in clinical trials.
The new year will see the emergence of yet another committee seeking to influence clinical trials. The World Health Organization is in the process of creating the snappily-titled “Technical Advisory Group on Development of Guidance on Best Practices for Clinical Trials,” and is currently sifting through applications for its membership.
This new group will have a very wide brief—in line with WHO’s global reach across 194 member countries and six regions. Top of its list of future duties is to develop guidance to help official implementation of “scientifically and ethically sound” clinical trials at national and regional levels. But the mandate extends further than government bodies. The group will also provide advice for non-state actors—WHO code for stakeholders, ranging from scientists and physicians to the medicines industry and non-profit organizations. This should cover “the design and conduct of clinical trials.”
Beyond those specific elements, the group should also help “strengthen the global clinical trial ecosystem.” What this means, for WHO, is “to meet the needs of major population groups that the intervention is intended to benefit, with a particular focus on under-represented populations”—and this point is further emphasized in the duties. The group should “ensure that the focus on under-represented populations, and that needs-driven research is adequately captured in the guidance developed.” And the group’s views will also be taken into account in WHO plans for strengthening the sustainability of infrastructure for clinical trials.
Part of the job will be assistance in liaising with clinical trials stakeholders worldwide—explicitly, clinical researchers, national regulatory authorities, research ethics committees, patients, and affected communities. A catch-all clause adds the task of assisting WHO “in identifying existing guidance and ongoing initiatives of relevance and ensuring that WHO’s work is complementary to ongoing initiatives.” That should provide some interesting moments in “liaising” with the major clinical trials regulatory activities already well underway in the US, EU, UK, and Japan—to say nothing of China! “The ability to work constructively with people from different cultural backgrounds and orientations” figures as one of the desired qualities of applicants.
There is also a COVID-19-related aspect to the work. The group will not only ensure that guidance adequately captures needs for high-quality trials and strengthening of capacity “in normal times;” it will advise on the development of procedures in place in every member state for rapid implementation of clinical trial protocols in times of health emergencies. Cue further intense liaison moments with other “ongoing initiatives.”
In its current conception, the advisory group is time limited. It will have about a dozen members, and meet virtually “at least three times each year until completion of the guidance.” No one gets paid—except travel expenses. It will be “multidisciplinary,” with members drawn from among scientists, healthcare professionals, healthcare regulators—or from an extensive list of other experts. These areas include clinical trial design, network coordination, infrastructure, and research capacity strengthening,regulatory authority clinical trial approval and product authorization, ethics in research and emergency public health response, patient and community engagement, and “needs of under-represented populations, such as women, particularly pregnant and lactating women, and children.” All members are to serve in their individual expert capacity and not represent any government, commercial entity, or “any other bodies, entities, institutions, or organizations.”
The process springs from a resolution adopted by WHO at its assembly in May 2022—a resolution that spoke of “strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination.” This mandated the WHO secretariat to review existing guidance and develop new guidance on best practices for clinical trials—and was strongly inspired by the preoccupation over recent years with pandemics. Hence, the resolution’s call for infrastructure that can function well “during a public health emergency of international concern.”
If you wanted to apply for the committee, I’m afraid this blog is too late for you. Applications just closed on Jan. 9; the invitation to apply was published only in December, and got lost among other bigger events. If it is any consolation to disappointed would-be candidates, this column will endeavor to provide information on the process and the outcome, so you can then contact the members of the group yourselves when it gets started.