Clinical trials with interim analyses: standardizing terminology to increase clarity
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
- Gernot Wassmer (ORCID: https://orcid.org/0000-0001-9397-1794)
- Tobias Mielke (ORCID: https://orcid.org/0000-0001-9479-5673)
- Christopher Jennison (ORCID: https://orcid.org/0000-0002-9812-1104)
- Cornelia Ursula Kunz (ORCID: https://orcid.org/0000-0002-8900-9401)
- Lisa V. Hampson (ORCID: https://orcid.org/0000-0003-3074-9170)
- Kaspar Rufibach (ORCID: https://orcid.org/0000-0002-2634-1167)
- Benjamin Hofner (ORCID: https://orcid.org/0000-0003-2810-3186)
- Elina Asikanius
Institutions
- Children's Oncology Group (CH)
- Boehringer Ingelheim (Germany) (DE)
- Friedrich-Alexander-Universität Erlangen-Nürnberg (DE)
- Merck Serono S.A. (Switzerland) (CH)
- Swiss Data Science Center (CH)
- Boehringer Ingelheim (Egypt) (EG)
- Janssen (Germany) (DE)
- Boehringer Ingelheim (South Korea) (KR)
- Finnish Medicines Agency Fimea (FI)
- University of Bath (GB)
- Paul Ehrlich Institut (DE)
Publication Details
- Journal
- Trials
- Published
- 2025-07-14
- DOI
- https://doi.org/10.1186/s13063-025-08942-3
- Citations
- 1
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 2.63