Engaging communities in therapeutics clinical research during pandemics: Experiences and lessons from the ACTIV COVID-19 therapeutics research initiative
Year: 2024
Type: article
Abstract: This manuscript addresses a critical topic: navigating complexities of conducting clinical trials during a pandemic. Central to this discussion is engaging communities to ensure diverse participation. The manuscript elucidates deliberate strategies employed to recruit minority communities with poor social drivers of health for participation in COVID-19 trials. The paper adopts a descriptive approach, eschewing analysis of data-driven efficacy of these efforts, and instead provides a comprehensive account of strategies utilized. The Accelerate COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership launched early in the COVID-19 pandemic to develop clinical trials to advance SARS-CoV-2 treatments. In this paper, ACTIV investigators share challenges in conducting research during an evolving pandemic and approaches selected to engage communities when traditional strategies were infeasible. Lessons from this experience include importance of community representatives' involvement early in study design and implementation and integration of well-developed public outreach and communication strategies with trial launch. Centralization and coordination of outreach will allow for efficient use of resources and the sharing of best practices. Insights gleaned from the ACTIV program, as outlined in this paper, shed light on effective strategies for involving communities in treatment trials amidst rapidly evolving public health emergencies. This underscores critical importance of community engagement initiatives well in advance of the pandemic.
DOI: 10.1017/cts.2024.561
Authors: David A. Wohl, Stacey J. Adam, Kevin W. Gibbs, Ari L. Moskowitz, Thomas L. Ortel, Upinder Singh, Nikolaus Jilg, Teresa H. Evering, William A. Fischer, Babafemi O. Taiwo, Eric S. Daar, Christopher J. Lindsell, Susanna Naggie, Russell L. Rothman, Sarah E. Dunsmore, M. Patricia McAdams, Julia Vail, Dushyantha Jayaweera
Institutions: University of North Carolina at Chapel Hill, Foundation for the National Institutes of Health, Wake Forest University Health Sciences, Wake Forest University, Montefiore Medical Center, Duke University, Stanford University, Brigham and Women's Hospital, Harvard University, Massachusetts General Hospital, Weill Cornell Medicine, Northwestern University, University of California, Los Angeles, UCLA Medical Center, Los Angeles Medical Center, Vanderbilt University, National Institutes of Health, National Center for Advancing Translational Sciences, National Institutes of Health Clinical Center, University of Miami
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,925
Award: G1050281965
OpenAlex ID: W4403437171