Evidence map›Paper›PMID 40497544›Full record

ArticleStatistics in medicine2025

Futility Monitoring in Clinical Trials.

Ana M Ortega-Villa, Megan C Grieco, Kevin Rubenstein, Jing Wang, Michael A Proschan

Abstract read
In one paragraph

Article in Statistics in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Ana M Ortega-VillaOffice of Biostatistics Research, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA.ORCID https://orcid.org/0000-0002-5589-9557
Megan C GriecoOffice of Biostatistics Research, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA.ORCID https://orcid.org/0009-0005-6642-1603
Kevin RubensteinClinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA.ORCID https://orcid.org/0000-0003-3516-5932
Jing WangClinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA.
Michael A ProschanOffice of Biostatistics Research, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA.ORCID https://orcid.org/0000-0002-9161-3739

Funding

WORK ORDER 126643 B539 EXPAND IC SUITE75N91019D00024 · NIAID · LEIDOS BIOMEDICAL RESEARCH, INC. · PI PENDLETON, RICHARD · 2019 to 2025
$3932.6M
NCI NIH HHS 75N91019D00024
6 · The paper itself

Abstract

At the beginning of a phase III clinical trial, there is great optimism. After all, the phase II trial results were encouraging. Then, early data from the phase III trial trend in the wrong way, but there is still an opportunity for the trend to reverse and become statistically significant by the end. At what point does optimism become denial of reality? How do we decide when a clinical trial is futile? What does futility even mean? This tutorial reviews different concepts and tools for evaluating futility, including conditional and predictive power, reverse conditional power, predicted interval plots, revised unconditional power, and beta spending functions.

Indexed as

Clinical Trials as TopicClinical Trials, Phase III as TopicMedical FutilityClinical Trials, Phase II as TopicData Interpretation, StatisticalHumansModels, Statisticalbeta spending functionsconditional powerfutility monitoringpredicted interval plotspredictive powerstochastic curtailment

Identifiers

PMID40497544
PMCPMC12153251

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.