Accelerating evidence generation: Addressing critical challenges and charting a path forward

• Published in: Journal of clinical and translational science 2024, Vol.8 (1), p.e184, Article e184
• Main Authors: Rim, Jeeyon G, Jackman, Jennifer G, Hornik, Christoph P, Rutter, Joni L, Warraich, Haider, Wittes, Janet, Fleisher, Lee, Anderson, Brian S, Krofah, Ester, Kinter, Elizabeth, Locke, Trevan, Kehoe, Lindsay, Abbasi, Ali, Marston, Hilary, Meeker-O'Connell, Ann, Weber, Wendy, Wang, Tracy, Hernandez, Adrian F, Landray, Martin, Palmer, Scott M
• Format: Article
• Language: English
• Subjects: Advocacy; Clinical trials; Collaboration; Costs; COVID-19; Design; Drug development; FDA approval; Grass roots movement; Health care; Health care expenditures; Health care policy; Healthcare delivery; Incentives; Infrastructure; Medicaid; Medical research; Medicare; Monetary incentives; patient advocacy; Patients; Pharmaceutical industry; population health; Public health; R&D; Regulatory approval; Research & development; Special Communication; Think tanks; Value-based care
• ISSN: 2059-8661; 2059-8661
• DOI: 10.1017/cts.2024.621

Efficient evidence generation to assess the clinical and economic impact of medical therapies is critical amid rising healthcare costs and aging populations. However, drug development and clinical trials remain far too expensive and inefficient for all stakeholders. On October 25-26, 2023, the Duke Clinical Research Institute brought together leaders from academia, industry, government agencies, patient advocacy, and nonprofit organizations to explore how different entities and influencers in drug development and healthcare can realign incentive structures to efficiently accelerate evidence generation that addresses the highest public health needs. Prominent themes surfaced, including competing research priorities and incentives, inadequate representation of patient population in clinical trials, opportunities to better leverage existing technology and infrastructure in trial design, and a need for heightened transparency and accountability in research practices. The group determined that together these elements contribute to an inefficient and costly clinical research enterprise, amplifying disparities in population health and sustaining gaps in evidence that impede advancements in equitable healthcare delivery and outcomes. The goal of addressing the identified challenges is to ultimately make clinical trials faster, more inclusive, and more efficient across diverse communities and settings.