ArticleStatistical methods in medical research2021
Unified exact design with early stopping rules for single arm clinical trials with multiple endpoints.
Wei Wei, Denise Esserman, Michael Kane, Daniel Zelterman
Abstract read
In one paragraphArticle in Statistical methods in medical research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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0citing papers in PubMed
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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 registryThe 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 literatureWho cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
4 · The recordCorrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
5 · Who and what moneyAuthors and funding
4 authors.
Michael KaneDepartment of Biostatistics, Yale School of Public Health, New Haven, CT, USA.
Daniel ZeltermanDepartment of Biostatistics, Yale School of Public Health, New Haven, CT, USA.
Funding
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9MYale Pathology Tissue Services Shared ResourceP30CA016359 · NCI · YALE UNIVERSITY · PI DAVID L RIMM · 1985 to 2026
$85.0MYale SPORE in Skin CancerP50CA121974 · NCI · YALE UNIVERSITY · PI DAVID F STERN · 2006 to 2026
$43.9MYale SPORE in Lung Cancer (YSILC): The Biology and Personalized Treatment of Lung CancerP50CA196530 · NCI · YALE UNIVERSITY · PI Shuangge Ma · 2015 to 2026
$31.1MViKTriY-PC Consortium Phase II SupplementUM1CA186689 · NCI · YALE UNIVERSITY · PI Patricia M. LoRusso · 2014 to 2026
$22.2MYale Head and Neck Cancer SPORE: Overcoming Treatment Resistance in Head and Neck CancerP50DE030707 · NIDCR · YALE UNIVERSITY · PI TOWNSEND, JEFFREY PETER · 2020 to 2024
$11.8MTargeting DNA Repair for Cancer Therapy.R35CA197574 · NCI · YALE UNIVERSITY · PI PETER M GLAZER · 2017 to 2026
$8.6MOncometabolites, DNA Repair, and CancerR01ES005775 · NIEHS · YALE UNIVERSITY · PI PETER M GLAZER · 1998 to 2026
$8.0MMeeting Community Needs Across the Prevention SpectrumU48DP005023 · DP · YALE UNIVERSITY · PI DUFFANY, KATHLEEN O'CONNOR · 2014 to 2018
$3.9MUncovering the Biology of Resistance to Tyrosine Kinase Inhibitors in EGFR Mutant Lung Cancer Patient-Derived Models.U01CA235747 · NCI · YALE UNIVERSITY · PI NGUYEN, DON X, POLITI, KATERINA ABIGAIL · 2019 to 2023
$3.9MIndividualized monitoring of treatment response and resistance in patients with metastatic melanomaR01CA223481 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI MURTAZA, MUHAMMED · 2018 to 2022
$2.0MCell-Penetrating Anti-DNA Antibody for Radiosensitization and Cancer TherapyR01CA168733 · NCI · YALE UNIVERSITY · PI GLAZER, PETER M · 2013 to 2017
$1.7MNCATS NIH HHS UL1 TR001863NCCDPHP CDC HHS U48 DP005023NCI NIH HHS P30 CA016359NCI NIH HHS P50 CA121974NCI NIH HHS P50 CA196530NCI NIH HHS R01 CA168733NCI NIH HHS R01 CA177719NCI NIH HHS R01 CA223481NCI NIH HHS R35 CA197574NCI NIH HHS U01 CA235747NCI NIH HHS UM1 CA186689NIAID NIH HHS R41 AI120546NIDCR NIH HHS P50 DE030707NIEHS NIH HHS R01 ES005775
6 · The paper itselfAbstract
Adaptive designs are gaining popularity in early phase clinical trials because they enable investigators to change the course of a study in response to accumulating data. We propose a novel design to simultaneously monitor several endpoints. These include efficacy, futility, toxicity and other outcomes in early phase, single-arm studies. We construct a recursive relationship to compute the exact probabilities of stopping for any combination of endpoints without the need for simulation, given pre-specified decision rules. The proposed design is flexible in the number and timing of interim analyses. A R Shiny app with user-friendly web interface has been created to facilitate the implementation of the proposed design.
Indexed as
Clinical Trials as TopicMedical FutilityResearch DesignComputer SimulationProbabilitybiomarker endpointsconditional powerearly phaseGo/no go decisionsmultiple endpoints
Identifiers
PMID34159859
PMCPMC8959087
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