Problem Statement

The COVID-19 pandemic highlighted longstanding problems with the U.S. clinical trials enterprise and underscored the critical need to partner with community-based practices–particularly those that have had limited opportunities to participate in, contribute to, and benefit from clinical research. Community-based practices are well-positioned to generate actionable evidence that can advance drug development and improve patient care. However, coordinated efforts are needed to address infrastructure needs, provide support and guidance, and establish good governance for community-based sites. Such approaches are essential for overcoming barriers to partnership, fostering knowledge and resource sharing, and building trust–for the benefit of patients and their communities nationwide.

Objectives

The goal of this action collaborative, an ad hoc activity associated with the National Academies Forum on Drug Discovery, Development, and Translation, is to better understand the opportunities and challenges for community-based practices to engage in the clinical trials enterprise. The collaborative provides an opportunity to help build trust and meaningful relationships among community-based practices, patient groups, providers, researchers, regulators, and others who are working in drug research and development.

The listening sessions are an opportunity for people working in community-based practices to share perspectives on:

• the benefits and drawbacks of engaging the clinical trials enterprise;
• the strengths of their communities;
• practical barriers for practicing clinicians and community sites (e.g., community health providers, pharmacies, community non-profits, faith-based organizations, public health representatives, and community advocates) to engage in clinical trials and/or research;
• approaches and resources needed to build effective partnerships, infrastructure, and workforce;
• ways that industry, government, other stakeholders could better support community practices engaging in clinical research.

The collaborative is an ad hoc activity associated with the Forum on Drug Discovery, Development, and Translation (the Forum) at the National Academies of Sciences, Engineering, and Medicine (the National Academies). The work of the collaborative does not necessarily represent the views of any one organization, the Forum, or the National Academies and is not subjected to the review procedures of, nor is it a report or product of, the National Academies.