Evidence map›Paper›PMID 24905465›Full record

ArticleJournal of biopharmaceutical statistics2015

Impact of Copula Directional Specification on Multi-Trial Evaluation of Surrogate End Points.

Lindsay A Renfro, Hongwei Shang, Daniel J Sargent

Abstract readEvaluation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of biopharmaceutical statistics, 2015. 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. Bivariate copula regression models for semi-competing risks.Statistical methods in medical research · 2023
    Article
  2. Review
  3. Survival analyses in lung cancer.Journal of thoracic disease · 2016
    Article
  4. Multitrial Evaluation of Progression-Free Survival as a Surrogate End Point for Overall Survival in First-Line Extensive-Stage Small-Cell Lung Cancer.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2015
    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.

Lindsay A Renfroa Division of Biomedical Statistics and Informatics , Mayo Clinic , Rochester , Minnesota , USA.
Hongwei Shang
Daniel J Sargent

Funding

Methodology for development, validation, and use of novel endpoints in oncologyR01CA174779 · NCI · MAYO CLINIC ROCHESTER · PI MANDREKAR, SUMITHRA JAY · 2014 to 2017
$1.2M
NCI NIH HHS R01 CA174779
6 · The paper itself

Abstract

Evaluation of surrogate end points using patient-level data from multiple trials is the gold standard, where multi-trial copula models are used to quantify both patient-level and trial-level surrogacy. While limited consideration has been given in the literature to copula choice (e.g., Clayton), no prior consideration has been given to direction of implementation (via survival vs. distribution functions). We demonstrate that even with the "correct" copula family, directional misspecification leads to biased estimates of patient-level and trial-level surrogacy. We illustrate with a simulation study and a reanalysis of disease-free survival as a surrogate for overall survival in early stage colon cancer.

Indexed as

BiomarkersClinical Trials as TopicColorectal NeoplasmsDisease-Free SurvivalEndpoint DeterminationHumansBiomarkersClinical trialsCopulaMeta-analysisSurrogate end pointsSurvival copula

Identifiers

PMID24905465
PMCPMC4270950

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.