Evidence map›Paper›PMID 24872363›Full record

ArticleClinical trials (London, England)2014

The utility of Bayesian predictive probabilities for interim monitoring of clinical trials.

Benjamin R Saville, Jason T Connor, Gregory D Ayers, JoAnn Alvarez

Abstract read
In one paragraph

Article in Clinical trials (London, England), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 3 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

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

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  16. Benchmarking non-inferiority design and analysis through the Z-score.European journal of clinical pharmacology · 2025
    Article
  17. Futility Monitoring in Clinical Trials.Statistics in medicine · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors.

Benjamin R SavilleDepartment of Biostatistics, School of Medicine, Vanderbilt University, Nashville, TN, USA b.saville@vanderbilt.edu.
Jason T ConnorBerry Consultants, Austin, TX, USA College of Medicine, University of Central Florida, Orlando, FL, USA.
Gregory D AyersDepartment of Biostatistics, School of Medicine, Vanderbilt University, Nashville, TN, USA.
JoAnn AlvarezDepartment of Biostatistics, School of Medicine, Vanderbilt University, Nashville, TN, USA.

Funding

Tumor Immunology and Microenvironment Research ProgramP30CA068485 · NCI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI MATTHEW J TYSKA · 1995 to 2026
$172.8M
Understanding and Controlling p120 Dysfunction in CRCP50CA095103 · NCI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI COFFEY, ROBERT J. · 2002 to 2017
$33.6M
NCI NIH HHS P30 CA068485NCI NIH HHS P50 CA095103
6 · The paper itself

Abstract

backgroundBayesian predictive probabilities can be used for interim monitoring of clinical trials to estimate the probability of observing a statistically significant treatment effect if the trial were to continue to its predefined maximum sample size. PURPOSE: We explore settings in which Bayesian predictive probabilities are advantageous for interim monitoring compared to Bayesian posterior probabilities, p-values, conditional power, or group sequential methods.

resultsFor interim analyses that address prediction hypotheses, such as futility monitoring and efficacy monitoring with lagged outcomes, only predictive probabilities properly account for the amount of data remaining to be observed in a clinical trial and have the flexibility to incorporate additional information via auxiliary variables. LIMITATIONS: Computational burdens limit the feasibility of predictive probabilities in many clinical trial settings. The specification of prior distributions brings additional challenges for regulatory approval.

conclusionsThe use of Bayesian predictive probabilities enables the choice of logical interim stopping rules that closely align with the clinical decision-making process.

Identifiers

PMID24872363
PMCPMC4247348

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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.