Evidence map›Paper›PMID 41929638›Full record

ArticleJournal of the Royal Statistical Society. Series B, Statistical methodology2026

Harmonized Estimation of Subgroup-Specific Treatment Effects in Randomized Trials: The Use of External Control Data.

Daniel Schwartz, Riddhiman Saha, Steffen Ventz, Lorenzo Trippa

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of the Royal Statistical Society. Series B, Statistical methodology, 2026. 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

4 authors.

Daniel SchwartzDepartment of Biostatistics, Harvard T.H. Chan School of Public Health, United States.
Riddhiman SahaDepartment of Biostatistics, Harvard T.H. Chan School of Public Health, United States.
Steffen VentzDivision of Biostatistics, School of Public Health, University of Minnesota, United States.
Lorenzo TrippaDepartment of Biostatistics, Harvard T.H. Chan School of Public Health, United States.

Funding

Women's CancerP30CA077598 · NCI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI Timothy C. Hallstrom · 1998 to 2026
$100.4M
Training Grant in Quantitative Sciences for Cancer ResearchT32CA009337 · NCI · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI QUACKENBUSH, JOHN, TRIPPA, LORENZO · 1986 to 2025
$12.3M
Statistical Methods and Validation Analyses for the Integration of External Data in Clinical TrialsR01LM013352 · NLM · DANA-FARBER CANCER INST · PI TRIPPA, LORENZO · 2021 to 2024
$1.5M
NCI NIH HHS P30 CA077598NCI NIH HHS T32 CA009337NLM NIH HHS R01 LM013352
6 · The paper itself

Abstract

Subgroup analyses of randomized controlled trials (RCTs) constitute an important component of the drug development process in precision medicine. In particular, subgroup analyses of early-stage trials often influence the design and eligibility criteria of subsequent confirmatory trials and ultimately influence which subpopulations will receive the treatment after regulatory approval. However, subgroup analyses are often complicated by small sample sizes, which leads to substantial uncertainty about subgroup-specific treatment effects. We explore the use of external control (EC) data to augment RCT subgroup analyses. We define and discuss

Indexed as

historical controlmodel misspecificationreal world datashrinkage estimationsubgroup analysis

Identifiers

PMID41929638
PMCPMC13042083

What OpenQuestion holds

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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.