Evidence map›Paper›PMID 40600894›Full record

SynthesisJournal of the National Cancer Institute2025

Expected vs observed effect sizes for survival endpoints in phase 3 oncology trials.

Sophia J Lamp, Gina L Mazza

Abstract readSystematic Review
In one paragraph

Synthesis in Journal of the National Cancer Institute, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. AI-based augmentation of oncology clinical trials.Nature reviews. Clinical oncology · 2026
    Review
  2. Review
  3. Review
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

2 authors.

Sophia J LampDepartment of Psychology, Arizona State University, Tempe, AZ, United States.ORCID 0000-0001-7853-3569
Gina L MazzaDepartment of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ, United States.ORCID 0000-0002-5305-6193

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Felicity Enders · 1985 to 2026
$151.3M
NCI NIH HHS P30 CA015083
6 · The paper itself

Abstract

More than half of randomized phase 3 oncology trials fail to meet their primary endpoints, often despite favorable results from phase 1 and phase 2 trials. One potential reason for this high failure rate is effect size selection practices for powering these trials. In a systematic review of phase 3 oncology trials published in 10 top medical journals in 2023, we identified a pattern of effect size overestimation for survival endpoints, where the expected hazard ratios (average HR = 0.66) were stronger than those observed in the primary analyses (average HR = 0.72; 2-sided signed-rank test P = .0035). Across 111 trials, 82 of 143 (57.3%) observed hazard ratios for primary survival endpoints were weaker than expected; among 5 journals with 2023 impact factors between 9.9 and 56.7 (vs 58.7-98.4 for the top 5 journals), this ratio was 70.2% (59/84). These results suggest that phase 3 oncology trials are likely underpowered, contributing to the high failure rates in oncology research.

Indexed as

Clinical Trials, Phase III as TopicEndpoint DeterminationMedical OncologyNeoplasmsRandomized Controlled Trials as TopicHumansResearch Design

Identifiers

PMID40600894
PMCPMC12415963

What OpenQuestion holds

Textmetadata
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.