Below please find link(s) to new coronavirus-related content published today in Annals of Internal Medicine. All coronavirus-related content published in Annals of Internal Medicine is free to the public. A complete collection is available at https://annals.org/aim/pages/coronavirus-content.
1. ACTIV Therapeutics-Clinical Working Group describe development and launch of nine master protocols for evaluating therapeutic agents for COVID-19
Free full text: https://www.acpjournals.org/doi/10.7326/M21-1269
Members of the ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines) workgroup, a partnership of experts representing government, industry, and academia, describe how nine master protocols for evaluating therapeutic agents for COVID-19 were designed, developed, and launched, and lessons learned that may be useful in meeting the challenges of a future pandemic. Their commentary is published in Annals of Internal Medicine.
The Therapeutics-Clinical Working Group (TX-Clinical WG) within ACTIV, which is coordinated by the Foundation for the NIH, was created to develop a systematic review process for identification and prioritization of therapeutic candidates and to create master protocols for efficient, flexible, rigorous assessment of safety and efficacy of selected candidates. This is important because a master protocol uses a single trial infrastructure, trial design, and protocol to evaluate 1 or more drugs in 1 or more diseases for efficient and accelerated drug development. The protocols clearly define research objectives for candidates being studied and all candidates are evaluated against a control rather than each other. The protocols call for randomization, shared controls, adequate power to detect moderately sized treatment effects with respect to primary end points, early stopping rules if a trial proves futile, design adaptations, graduation rules, and end point alignment. Currently, the protocols are being used to evaluate existing and new drugs to treat patients in four clinical population categories: critically ill/ventilated; hospitalized/moderately ill; outpatient; and prevention.
The authors detail several trials currently underway using the master protocols and the lessons learned so far. Their hope is that this initiative will help to lessen the mortality and morbidity of COVID-19 and that the process developed may inform responses to future pandemics.
Media contacts: A PDF for this article is not yet available. Please click the link to read full text. To speak with the corresponding author, Stacey Adam, PhD, please contact Katherine Thompson at kthompson@fnih.org.
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Free full text: https://www.acpjournals.org/doi/10.7326/M21-0997