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
Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Duke University Medical Center, Durham, NC, USA.
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
J Clin Transl Sci. 2024 Oct 31;8(1):e184. doi: 10.1017/cts.2024.621. eCollection 2024.
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.
在医疗成本不断上升和人口老龄化的背景下，生成有效的证据以评估医学疗法的临床和经济影响至关重要。然而，对于所有利益相关者而言，药物研发和临床试验仍然成本过高且效率低下。2023年10月25日至26日，杜克临床研究所召集了来自学术界、行业、政府机构、患者权益倡导组织和非营利组织的领导人，探讨药物研发和医疗保健领域的不同实体及影响因素如何调整激励结构，以有效加速生成满足最高公共卫生需求的证据。会上浮现出一些突出主题，包括相互竞争的研究重点和激励措施、临床试验中患者群体代表性不足、在试验设计中更好利用现有技术和基础设施的机会，以及研究实践中提高透明度和问责制的必要性。该小组认定，这些因素共同导致临床研究企业效率低下且成本高昂，加剧了人群健康方面的差异，并使证据缺口持续存在，阻碍了公平医疗服务和结果的改善。应对已确定挑战的目标是最终使临床试验在不同社区和环境中更快、更具包容性且更高效。
