1. Lessons Learned from National Heart, Lung, and Blood Institute Covid-19 Clinical Trials.
- Author
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Thomas SM, Harrington RA, Yancy CW, Nugent D, Erzurum S, Bernard GR, Cushman M, Hochman JS, Ridker PM, Ortel TL, Collins SP, Callaway CW, Nolen TL, Womack KN, Brown SM, Gelijns A, Geraci M, Ginde AA, Key NS, Krishnan JA, LaVange L, Wisniewski SR, Berdan L, Punturieri A, Goff DC, and Patterson AP
- Subjects
- Humans, United States epidemiology, SARS-CoV-2, COVID-19 Drug Treatment, COVID-19 epidemiology, Clinical Trials as Topic, National Heart, Lung, and Blood Institute (U.S.)
- Abstract
AbstractIn response to the Covid-19 pandemic, the National Heart, Lung, and Blood Institute launched five multisite clinical trials testing candidate host tissue-directed medical interventions to hasten recovery, improve function, and reduce morbidity and mortality. Speed, flexibility, and collaboration were essential. This article from the Steering and Executive committees describes the Collaborating Network of Networks for Evaluating Covid-19 and Therapeutic Strategies (CONNECTS) research program that enrolled 6690 participants and evaluated 18 intervention strategies using 10 molecular agents across the care continuum (outpatient, inpatient, and post discharge), and reports lessons learned from this initiative. Successes include rapid trial execution through collaboration and adaptive platform designs. Challenges that impeded efficiency included time required to execute subcontracts, constraints on clinical research workforce, and limited research infrastructure in nonacademic settings.
- Published
- 2024
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