Evidence map›Paper›PMID 25061255›Full record

ArticleComputational statistics & data analysis2014

Center-Within-Trial Versus Trial-Level Evaluation of Surrogate Endpoints.

Lindsay A Renfro, Qian Shi, Yuan Xue, Junlong Li, Hongwei Shang, Daniel J Sargent

Abstract read
In one paragraph

Article in Computational statistics & data analysis, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 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

3 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  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

6 authors.

Lindsay A RenfroDivision of Biomedical Statistics and Informatics, Mayo Clinic, 200 First Street SW, Rochester, MN 55905.
Qian ShiDivision of Biomedical Statistics and Informatics, Mayo Clinic.
Yuan XueDepartment of Statistics, University of Virginia.
Junlong LiDepartment of Biostatistics, Harvard School of Public Health.
Hongwei ShangHP Labs.
Daniel J SargentDivision of Biomedical Statistics and Informatics, Mayo Clinic.

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 candidate surrogate endpoints using individual patient data from multiple clinical trials is considered the gold standard approach to validate surrogates at both patient and trial levels. However, this approach assumes the availability of patient-level data from a relatively large collection of similar trials, which may not be possible to achieve for a given disease application. One common solution to the problem of too few similar trials involves performing trial-level surrogacy analyses on trial sub-units (e.g., centers within trials), thereby artificially increasing the trial-level sample size for feasibility of the multi-trial analysis. To date, the practical impact of treating trial sub-units (centers) identically to trials in multi-trial surrogacy analyses remains unexplored, and conditions under which this ad hoc solution may in fact be reasonable have not been identified. We perform a simulation study to identify such conditions, and demonstrate practical implications using a multi-trial dataset of patients with early stage colon cancer.

Indexed as

clinical trialsmeta-analysissurrogate endpointssurvival analysis

Identifiers

PMID25061255
PMCPMC4104720

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.