Evidence map›Paper›PMID 39222723›Full record

ArticleJournal of clinical epidemiology2024

Surrogate endpoint metaregression: useful statistics for regulators and trialists.

Stuart G Baker, Marissa N D Lassere, Wang Pok Lo

Abstract read
In one paragraph

Article in Journal of clinical epidemiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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.

Stuart G BakerDivision of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA. Electronic address: sb16i@nih.gov.
Marissa N D LassereSchool of Population Health, UNSW, St George Hospital, Sydney, Australia.
Wang Pok LoCentre for Population Health Sciences, Usher Institute, University of Edinburgh, Edinburgh, UK.

Funding

Intramural NIH HHS Z99 CA999999
6 · The paper itself

Abstract

objectivesThe main purpose of using a surrogate endpoint is to estimate the treatment effect on the true endpoint sooner than with a true endpoint. Based on a metaregression of historical randomized trials with surrogate and true endpoints, we discuss statistics for applying and evaluating surrogate endpoints.

methodsWe computed statistics from 2 types of linear metaregressions for trial-level data: simple random effects and novel random effects with correlations among estimated treatment effects in trials with more than 2 arms. A key statistic is the estimated intercept of the metaregression line. An intercept that is small or not statistically significant increases confidence when extrapolating to a new treatment because of consistency with a single causal pathway and invariance to labeling of treatments as controls. For a regulator applying the metaregression to a new treatment, a useful statistic is the 95% prediction interval. For a clinical trialist planning a trial of a new treatment, useful statistics are the surrogate threshold effect proportion, the sample size multiplier adjusted for dropouts, and the novel true endpoint advantage.

resultsWe illustrate these statistics with surrogate endpoint metaregressions involving antihypertension treatment, breast cancer screening, and colorectal cancer treatment.

conclusionRegulators and trialists should consider using these statistics when applying and evaluating surrogate endpoints.

Indexed as

BiomarkersRandomized Controlled Trials as TopicAntihypertensive AgentsBreast NeoplasmsColorectal NeoplasmsData Interpretation, StatisticalEndpoint DeterminationFemaleHumansMeta-Analysis as TopicRegression AnalysisAntihypertensive AgentsBiomarkersAntihypertension treatmentCancer screeningCancer treatmentClinical trialsMeta-analysisSurrogate endpoints

Identifiers

PMID39222723
PMCPMC11609000

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.