Evidence map›Paper›PMID 40881384›Full record

ArticleJournal of nonparametric statistics2025

Avoiding the Surrogate Paradox: An Empirical Framework for Assessing Assumptions.

Emily Hsiao, Lu Tian, Layla Parast

Abstract read
In one paragraph

Article in Journal of nonparametric statistics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. 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

3 authors.

Emily HsiaoDepartment of Statistics and Data Sciences, University of Texas at Austin, 105 E 24th St D9800, Austin, TX 78705.
Lu TianDepartment of Biomedical Data Science, Stanford University, 1265 Welch Road, Stanford, CA 94305.
Layla ParastDepartment of Statistics and Data Sciences, University of Texas at Austin, 105 E 24th St D9800, Austin, TX 78705.

Funding

Robust Statistical Methods to Identify and Use Surrogate Markers in DiabetesR01DK118354 · NIDDK · UNIVERSITY OF TEXAS AT AUSTIN · PI PARAST, LAYLA · 2018 to 2025
$2.0M
NIDDK NIH HHS R01 DK118354
6 · The paper itself

Abstract

The use of surrogate markers to replace a primary outcome in clinical trials has the potential to allow earlier decisions about the effectiveness of a treatment when a direct measurement of the primary outcome is difficult to obtain. However, the surrogate paradox, which occurs when a treatment has a positive effect on the surrogate marker but a negative effect on the primary outcome, may lead researchers to make incorrect conclusions about the treatment benefit. In this paper, we propose a formal nonparametric framework to empirically examine and test assumptions that ensure avoidance of the surrogate paradox. For each assumption, we propose a nonparametric hypothesis test, formally derive the properties of the test, and analyze its performance in finite samples in a variety of simulation settings. We apply our proposed testing framework to data from the the Diabetes Prevention Program clinical trial.

Indexed as

hypothesis testingmonotonicitystochastic dominancesurrogate markertreatment effect

Identifiers

PMID40881384
PMCPMC12382359

What OpenQuestion holds

Textmetadata
LicenceTDM
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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.