Evidence map›Paper›PMID 40047791›Full record

ArticleStatistics in medicine2025

Statistical Inference for a Two-Stage Adaptive Seamless Design Using Different Binary Endpoints.

Ryota Ishii, Kenichi Takahashi, Kazushi Maruo, Masahiko Gosho

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Statistics in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–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 synthesis or guideline pooled it.

  1. Pooled it
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

4 authors.

Ryota IshiiDepartment of Biostatistics, Institute of Medicine, University of Tsukuba, Ibaraki, Japan.ORCID 0000-0003-1725-4579
Kenichi TakahashiJapan Development, MSD K. K., Tokyo, Japan.ORCID 0000-0003-3602-9430
Kazushi MaruoDepartment of Biostatistics, Institute of Medicine, University of Tsukuba, Ibaraki, Japan.ORCID 0000-0002-3093-0386
Masahiko GoshoDepartment of Biostatistics, Institute of Medicine, University of Tsukuba, Ibaraki, Japan.ORCID 0000-0002-5973-9163

Funding

Japan Society for the Promotion of Science 22K19682Japan Society for the Promotion of Science 24K02662
6 · The paper itself

Abstract

Adaptive seamless design, which integrates phases II and III into a single trial comprising two stages, is garnering increasing interest in the efficient drug development. The first stage involves selecting promising treatment group(s), followed by comparing the efficacy between the selected and control groups in the second stage. This study focused on a two-stage adaptive seamless design where treatment selection is based on a short-term binary endpoint, while the comparison is based on a long-term binary endpoint. Recently, exact and mid-

Indexed as

Clinical Trials, Phase II as TopicClinical Trials, Phase III as TopicEndpoint DeterminationResearch DesignBiasComputer SimulationConfidence IntervalsData Interpretation, StatisticalDrug DevelopmentHumansLikelihood FunctionsModels, Statisticalbias adjustmentconfidence intervalseamless phase II/III designshort‐term endpoint

Identifiers

PMID40047791
PMCPMC11884423

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.