Evidence map›Paper›PMID 40660264›Full record

ArticleTrials2025

Clinical trials with interim analyses: standardizing terminology to increase clarity.

Elina Asikanius, Benjamin Hofner, Lisa V Hampson, Gernot Wassmer, Christopher Jennison, Tobias Mielke, Cornelia Ursula Kunz, Kaspar Rufibach

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Elina Asikanius *Finnish Medicines Agency, Turku, Finland.
Benjamin Hofner *Section Data Science and Methods, Paul-Ehrlich-Institut, Langen, Germany.
Lisa V HampsonAdvanced Methodology & Data Science, Basel, Switzerland.
Gernot WassmerRPACT GbR, Am Rodenkathen 11, 23611, Sereetz, Germany.
Christopher JennisonDepartment of Mathematical Sciences, University of Bath, Bath, UK.
Tobias MielkeStatistics and Decision Sciences, Janssen-Cilag GmbH, Neuss, Germany.
Cornelia Ursula Kunz *Methodology Group, Global Biostatistics and Data Sciences, Boehringer-Ingelheim, Biberach, Germany.
Kaspar Rufibach *Methods, Collaboration, and Outreach Group, Product Development Data Sciences (MCO), Basel, Switzerland. kaspar.rufibach@merckgroup.com.ORCID http://orcid.org/0000-0002-2634-1167

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Clinical Trials as TopicEndpoint DeterminationResearch DesignTerminology as TopicData Interpretation, StatisticalHumans

Identifiers

PMID40660264
PMCPMC12261654

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.