Evidence map›Paper›PMID 27669414›Full record

ArticleBiometrics2017

Testing violations of the exponential assumption in cancer clinical trials with survival endpoints.

Gang Han, Michael J Schell, Heping Zhang, Daniel Zelterman, Lajos Pusztai, Kerin Adelson, Christos Hatzis

Abstract read
In one paragraph

Article in Biometrics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Trends in the Price per Median and Mean Life-Year Gained Among Newly Approved Cancer Therapies 1995 to 2017.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2019
    Article
  5. 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

7 authors.

Gang HanDepartment of Epidemiology and Biostatistics, School of Public Health, Texas A&M University, 212 Adriance Lab Road, College Station, Texas 77843, U.S.A.
Michael J SchellThe Biostatistics and Bioinformatics Department, H. Lee Moffitt Cancer Center & Research Institute, 12902 Magnolia Drive, Tampa, Florida, 33612, U.S.A.
Heping ZhangDepartment of Biostatistics, Yale University School of Public Health, 60 College Street, New Haven, Connecticut, 06520, U.S.A.
Daniel ZeltermanDepartment of Biostatistics, Yale University School of Public Health, 60 College Street, New Haven, Connecticut, 06520, U.S.A.
Lajos PusztaiYale Comprehensive Cancer Center, Yale School of Medicine, 333 Cedar Street, New Haven, Connecticut, 06520, U.S.A.
Kerin AdelsonYale Comprehensive Cancer Center, Yale School of Medicine, 333 Cedar Street, New Haven, Connecticut, 06520, U.S.A.
Christos HatzisYale Comprehensive Cancer Center, Yale School of Medicine, 333 Cedar Street, New Haven, Connecticut, 06520, U.S.A.

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI KENNETH Lynn WRIGHT · 1998 to 2026
$93.5M
Yale Pathology Tissue Services Shared ResourceP30CA016359 · NCI · YALE UNIVERSITY · PI DAVID L RIMM · 1985 to 2026
$85.0M
Yale SPORE in Lung Cancer (YSILC): The Biology and Personalized Treatment of Lung CancerP50CA196530 · NCI · YALE UNIVERSITY · PI Shuangge Ma · 2015 to 2026
$31.1M
NCI NIH HHS P30 CA016359NCI NIH HHS P30 CA076292NCI NIH HHS P50 CA196530
6 · The paper itself

Abstract

Personalized cancer therapy requires clinical trials with smaller sample sizes compared to trials involving unselected populations that have not been divided into biomarker subgroups. The use of exponential survival modeling for survival endpoints has the potential of gaining 35% efficiency or saving 28% required sample size (Miller, 1983), making personalized therapy trials more feasible. However, the use of exponential survival has not been fully accepted in cancer research practice due to uncertainty about whether or not the exponential assumption holds. We propose a test for identifying violations of the exponential assumption using a reduced piecewise exponential approach. Compared with an alternative goodness-of-fit test, which suffers from inflation of type I error rate under various censoring mechanisms, the proposed test maintains the correct type I error rate. We conduct power analysis using simulated data based on different types of cancer survival distribution in the SEER registry database, and demonstrate the implementation of this approach in existing cancer clinical trials.

Indexed as

NeoplasmsBiomarkersHumansRegistriesSample SizeSurvival AnalysisUncertaintyBiomarkersCensoringChange-point modelingFailure rateSurvival analysisUniformly most powerful unbiased test

Identifiers

PMID27669414
PMCPMC6093291

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.