Clinical trials with interim analyses: standardizing terminology to increase clarity

Asikanius E, Hofner B, Hampson LV, Wassmer G, Jennison C, Mielke T, Kunz CU, Rufibach K (2025)

Publication Type: Journal article

Publication year: 2025

Journal

Trials BioMed Central

Book Volume: 26

Article Number: 247

Journal Issue: 1

DOI: 10.1186/s13063-025-08942-3

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.

Authors with CRIS profile

Benjamin Hofner

Involved external institutions

Finnish Medicines Agency Fimea

Finland (FI) Paul Ehrlich Institute / Paul-Ehrlich-Institut – Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel (PEI)

Germany (DE) RPACT GbR

Germany (DE) University of Bath

United Kingdom (GB) Janssen-Cilag GmbH

Germany (DE) Boehringer Ingelheim Pharma GmbH & Co. KG

Germany (DE)

How to cite

APA:

Asikanius, E., Hofner, B., Hampson, L.V., Wassmer, G., Jennison, C., Mielke, T.,... Rufibach, K. (2025). Clinical trials with interim analyses: standardizing terminology to increase clarity. Trials, 26(1). https://doi.org/10.1186/s13063-025-08942-3

MLA:

Asikanius, Elina, et al. "Clinical trials with interim analyses: standardizing terminology to increase clarity." Trials 26.1 (2025).

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