Evidence map›Paper›PMID 39348660›Full record

ArticleJCO precision oncology2024

Evidenced-Based Prior for Estimating the Treatment Effect of Phase III Randomized Trials in Oncology.

Alexander D Sherry, Pavlos Msaouel, Gabrielle S Kupferman, Timothy A Lin, Joseph Abi Jaoude, Ramez Kouzy, Zachary R McCaw, Ethan B Ludmir, Erik van Zwet

Abstract read
In one paragraph

Article in JCO precision oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
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  5. Article
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  10. Global & regional health technology assessment
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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

9 authors.

Alexander D SherryDepartment of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0001-5115-1691
Pavlos MsaouelDepartment of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0001-6505-8308
Gabrielle S KupfermanDepartment of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0003-2088-4395
Timothy A LinDepartment of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0003-4183-9120
Joseph Abi JaoudeDepartment of Radiation Oncology, Stanford University, Stanford, CA.
Ramez KouzyDepartment of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-1521-0495
Zachary R McCawInsitro, South San Francisco, CA.ORCID 0000-0002-2006-9828
Ethan B LudmirDepartment of Gastrointestinal Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-5472-5344
Erik van ZwetDepartment of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.ORCID 0000-0001-5537-3179

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DIANE BODURKA · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

purposeThe primary results of phase III oncology trials may be challenging to interpret, given that results are generally based on

methodsWe curated 415 phase III randomized trials enrolling 338,600 patients published between 2004 and 2020. A phase III prior probability distribution for the treatment effect was developed on the basis of a three-component zero-mean mixture distribution of the observed z-scores. Using this prior, we computed the probability of clinically meaningful benefit (hazard ratio [HR] <0.8). The distribution of signal-to-noise ratios and power of phase III oncology trials were compared with that of 23,551 randomized trials from the Cochrane Database.

resultsThe signal-to-noise ratios of phase III oncology trials tended to be much larger than randomized trials from the Cochrane Database. Still, the median power of phase III oncology trials was only 49% (IQR, 14%-95%), and the power was <80% in 65% of trials. Using the phase III oncology-specific prior, only 53% of trials claiming superiority (114 of 216) had a ≥90% probability of clinically meaningful benefits. Conversely, the probability that the experimental arm was superior to the control arm (HR <1) exceeded 90% in 17% of trials interpreted as having no benefit (34 of 199).

conclusionBy enabling computation of contextual probabilities for the treatment effect from summary statistics, our robust, highly practical tool, now posted on a user-friendly webpage, can aid the wider oncology community in the interpretation of phase III trials.

Indexed as

Clinical Trials, Phase III as TopicRandomized Controlled Trials as TopicEvidence-Based MedicineHumansMedical OncologyNeoplasmsSignal-To-Noise RatioTreatment Outcome

Identifiers

PMID39348660
PMCPMC11444522

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.