Clinical trials with interim analyses: Standardizing Terminology to increase clarity

2024/10/02 by Elina Asikanius, Asikanius, Elina, Benjamin Hofner +13 · 1 citation
Medicine · #Applications (stat.AP) #Biomedical Ethics and Regulation #Ethics in Clinical Research #FOS: Computer and information sciences #Health and Medical Research Impacts

paper · pdf · doi:10.48550/arxiv.2410.01478

openalex publication_date 2024/10/02 · openalex created_date 2024/10/29 · openalex updated_date 2026/07/28

Abstract

Interim analyses for group-sequential decision making are prevalent in clinical trials. Methodology is well established and has been routinely implemented over the last decades. Still, confusions and uncertainties on aspects of how to operationalize and interpret interim analyses exist for 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, with the aim to introduce standard terminology to mitigate misunderstandings and facilitate clearer discussions.

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