Evidence map›Paper›PMID 34474500›Full record

ArticleStatistics in medicine2021

Quantifying the feasibility of shortening clinical trial duration using surrogate markers.

Xuan Wang, Tianxi Cai, Lu Tian, Florence Bourgeois, Layla Parast

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Statistics in medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

5 authors.

Xuan WangDepartment of Biostatistics, Harvard University, Boston, Massachusetts, USA.ORCID 0000-0002-0011-5663
Tianxi CaiDepartment of Biostatistics, Harvard University, Boston, Massachusetts, USA.
Lu TianDepartment of Biomedical Data Science, Stanford University, Stanford, California, USA.ORCID 0000-0002-5893-0169
Florence BourgeoisHarvard-MIT Center for Regulatory Science, Boston, Massachusetts, USA.
Layla ParastStatistics Group, RAND Corporation, Santa Monica, California, USA.ORCID 0000-0002-7288-1009

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 potential benefit of using a surrogate marker in place of a long-term primary outcome is very attractive in terms of the impact on study length and cost. Many available methods for quantifying the effectiveness of a surrogate endpoint either rely on strict parametric modeling assumptions or require that the primary outcome and surrogate marker are fully observed that is, not subject to censoring. Moreover, available methods for quantifying surrogacy typically provide a proportion of treatment effect explained (PTE) measure and do not directly address the important questions of whether and how the trial can be ended earlier using the surrogate marker. In this article, we specifically address these important questions by proposing a PTE measure to quantify the feasibility of ending trials early based on endpoint information collected at an earlier landmark point

Indexed as

Clinical Trials as TopicBiomarkersComputer SimulationFeasibility StudiesHumansBiomarkerscensored datanonparametric estimationproportion of treatment effect explained by the surrogatesurrogate marker

Identifiers

PMID34474500
PMCPMC8595715

What OpenQuestion holds

Textmetadata
LicenceTDM
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.