Department of Biostatistics, University of Washington, Seattle, Washington, USA.
Wittes LLC, Washington, DC, USA.
JACC Heart Fail. 2024 Aug;12(8):1317-1327. doi: 10.1016/j.jchf.2024.02.016. Epub 2024 Mar 25.
Clinical trials are vital for assessing therapeutic interventions. The associated data monitoring committees (DMCs) safeguard patient interests and enhance trial integrity, thus promoting timely, reliable evaluations of those interventions. We face an urgent need to recruit and train new DMC members. The HFC (Heart Failure Collaboratory), a multidisciplinary public-private consortium of academics, trialists, patients, industry representatives, and government agencies, is working to improve the clinical trial ecosystem. The HFC aims to improve clinical trial efficiency and quality by standardizing concepts, and to help meet the demand for experienced individuals on DMCs by creating a standardized approach to training new members. This paper discusses the HFC's training workshop, and an apprenticeship model for new DMC members. It describes opportunities and challenges DMCs face, along with common myths and best practices learned through previous experiences, with an emphasis on data confidentiality and need for quality independent statistical reporting groups.
临床试验对于评估治疗干预措施至关重要。相关的数据监测委员会(DMC)保障了患者的利益,增强了试验的完整性,从而促进了对这些干预措施的及时、可靠评估。我们迫切需要招募和培训新的 DMC 成员。HFC(心力衰竭合作组织)是一个由学术界人士、试验人员、患者、行业代表和政府机构组成的多学科公私合作伙伴关系,旨在改善临床试验生态系统。HFC 旨在通过标准化概念来提高临床试验的效率和质量,并通过创建标准化的新成员培训方法来帮助满足对 DMC 有经验的个人的需求。本文讨论了 HFC 的培训研讨会和新 DMC 成员的学徒模式。它描述了 DMC 面临的机会和挑战,以及通过以往经验了解到的常见误解和最佳实践,重点是数据保密性和对高质量独立统计报告小组的需求。