Interim analyses are prevalent in clinical trials. Although methodology is well established, there are aspects of how to operationalize and interpret interim analyses which remain unclear to many stakeholders. In this paper, a team of statisticians from the pharmaceutical industry, academia, and regulatory agencies provide a multi-stakeholder perspective on the key concepts behind interim analyses and considerations on terminology. We illustrate our proposals using a hypothetical clinical trial.

翻译：中期分析在临床试验中普遍存在。尽管相关方法学已较为成熟，但如何具体实施和解释中期分析，对许多利益相关方而言仍存在不明确之处。本文汇集了来自制药行业、学术界和监管机构的统计学家团队，从中期分析的核心概念和术语考量出发，提供了多方利益相关者的综合视角。我们通过一项假设性临床试验案例来具体阐述相关建议。