More Coordination Sought for Exploding COVID-19 R&D Efforts
With hundreds of clinical trials for potential coronavirus therapies in the works concerns have mounted about the emergence of conflicting data, useless results, and wasted efforts from multiple overlapping efforts.
With hundreds of clinical trials for potential coronavirus therapies in the works-and even more in development-concerns have mounted about the emergence of conflicting data, useless results, and wasted efforts from multiple overlapping efforts. In response, the National Institutes of Health (NIH)
Widespread research activity is available from these and other organizations:
NIH Director Francis Collins emphasizes the importance of bringing “unassailable objectivity” to swiftly identify the most promising compounds from multiple stakeholders. Those priority therapies should gain fast and efficient regulatory oversight and vetting, moreover, through the involvement of FDA and the European Medicines Agency (EMA) in the partnership.
This initiative builds on earlier efforts, such as the
ACTIV priorities
The new NIH-based partnership appears poised to advance collaborative research more extensively, with industry and government partners providing infrastructure, subject matter expertise, and funding to identify top priority candidates for advanced testing. FNIH will manage an ACTIV steering committee to develop an inventory of potential candidates, launch master protocols with a single control arm, and set criteria for ranking potential candidates for first wave and subsequent evaluation. Another sub-group will set standards for preclinical evaluation methods through a central repository to assess models, extend high-throughput screening facilities, and compare approaches for identifying informative assays. And a third group will tap NIH’s extensive clinical trial network infrastructure to build capacity for expediting trials and to study different populations and disease stages.
To advance vaccine development, another ACTIV group will form a collaborative framework to map epitopes and develop assays, establish protocols for sampling and immunological analyses, collect clinical data on immunological responses and endpoints, and engage with regulators on surrogate endpoints for clinical evaluation.
ACTIV’s initial goal is to select six to eight compounds for clinical trials that assess different mechanisms of action, Collins explained in a
Establishing “really organized clinical trial capacity” is critical to be able to slot promising compounds into networks utilizing master protocols, Collins emphasized. Even if current studies of existing therapies such as remdesivir show benefit, he predicts a strong need for combination therapies going forward.
FDA is deeply engaged in all these working groups to ensure that the group’s clinical studies will meet regulatory standards. And it’s all moving “at rocket pace,” Collins observed, with the goal of identifying two to three promising therapies by July or August for further testing in the fall. A main benefit of this initiative, he noted, is that “all stakeholders are together around the table.” Biopharma companies are “not just pushing their own candidates,” he noted, and are offering clinical trial capacity “to get this done.”
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