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Clinical trials with interim analyses: standardizing terminology to increase clarity
Elina Asikanius1, Benjamin Hofner2,3, Lisa V Hampson4
1Finnish Medicines Agency, Turku, Finland.
Trials
|July 14, 2025
Summary
Interim analyses in clinical trials are common but often misunderstood. This paper clarifies key concepts and standardizes terminology to reduce confusion among researchers, regulators, and industry professionals.
Area of Science:
- Clinical Trials Methodology
- Biostatistics
- Regulatory Science
Background:
- Interim analyses are frequently used in clinical trials for group-sequential decision-making.
- Established methodologies exist, but practical application and interpretation lead to stakeholder confusion.
Purpose of the Study:
- To provide a multi-stakeholder perspective on interim analysis concepts.
- To introduce standard terminology for interim analyses.
- To mitigate misunderstandings and improve discussions regarding interim analyses.
Main Methods:
- A collaborative approach involving statisticians from industry, academia, and regulatory agencies.
- Focus on key concepts and operationalization of interim analyses.
- Development of standardized terminology.
Main Results:
- Identified key areas of confusion in the operationalization and interpretation of interim analyses.
- Proposed standardized terminology to address these ambiguities.
- Facilitated a common understanding across diverse stakeholder groups.
Conclusions:
- Standardized terminology is crucial for clear communication in clinical trial interim analyses.
- A multi-stakeholder consensus on concepts and language improves trial conduct and decision-making.
- This work aims to foster more efficient and transparent clinical trial processes.
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