Abstract：
To better understand the nature of Non-Core procedures and derive new insight into protocol simplification and optimization, Tufts CSDD collaborated with the FDA and sponsor companies to assess alignment on the rationale for collecting, and relevance of, Non-Core protocol data. Twelve sponsor companies classified and rated 700 distinct procedures from 19 pivotal trials supporting new drug and biologics approvals. FDA reviewers classified and rated 80 distinct procedures for three of the 19 pivotal trials. The results of this assessment indicate areas of alignment and misalignment. Sponsors and FDA reviewers agreed on the classification for more than half of endpoints. However, FDA reviewers classified a much higher percentage of procedures as Non-Core (26% vs. 18%) with the largest proportion (50%) of these procedures perceived as Core by sponsor companies. Sponsors indicated that one-out-of-six Non-Core procedures were administered due to perceived regulatory requirement and expectation. The results of this study characterize the challenge in aligning the different-and potentially conflicting-imperatives of sponsors and regulators and speak to the importance of more effective FDA-sponsor communication to help simplify protocol designs.
摘要：
为了更好地理解非核心程序的性质，并获得对协议简化和优化的新见解，塔夫茨CSDD与FDA和赞助公司合作，评估收集理由的一致性，和相关性，非核心协议数据。12家赞助商对来自19项支持新药和生物制剂批准的关键试验的700种不同程序进行了分类和评级。FDA审稿人对19项关键试验中的3项进行了80种不同的程序分类和评级。该评估的结果表明对齐和未对齐的区域。赞助商和FDA审稿人对超过一半的终点的分类达成了一致。然而,FDA审核员将更高比例的程序归类为非核心(26%与18%)，赞助商公司认为这些程序中比例最大(50%)。赞助商表示，由于感知到的监管要求和期望，六分之一的非核心程序被管理。这项研究的结果描述了在调整赞助商和监管机构的不同和潜在冲突的必要性方面面临的挑战，并谈到了更有效的FDA-赞助商沟通以帮助简化方案设计的重要性。
