Inclusionary Trials: A Review of Lessons Not Learned

Abstract

The COVID-19 pandemic revealed weaknesses in the public health infrastructure of the United States, including persistent barriers to engaging marginalized communities toward inclusion in clinical research, including trials. Inclusive participation in clinical trials is crucial for promoting vaccine confidence, public trust, and addressing disparate health outcomes. A long-standing body of literature describes the value of community-based participatory research in increasing marginalized community participation in research. Community-based participatory research emphasizes shared leadership with community members in all phases of the research process, including in the planning and implementation, interpretation, and dissemination. Shared leadership between academic and industry with marginalized communities can assist with inclusive participation in vaccine trials and increase public trust in the development of the vaccines and other therapies used during public emergencies. Nevertheless, epidemiologic and clinical research do not yet have a strong culture of community partnership in the scientific process, which takes time to build and therefore may be difficult to develop and rapidly scale to respond to the pandemic. We outline practices that contribute to a lack of inclusive participation and suggest steps that trialists and other researchers can take to increase marginalized communities' participation in research. Practices include planning for community engagement during the planning and recruitment phases, having regular dialogues with communities about their priorities, supporting them throughout a study, and navigating complex structural determinants of health. Additionally, we discuss how research institutions can support inclusive practices by reexamining their policies to increase participation in clinical trials and instilling institutional trustworthiness.

Keywords: clinical trials; community-based; inclusion; inclusive participation; minority recruitment; vaccine trials.