KMDATA: a curated database of reconstructed individual patient-level data from 153 oncology clinical trials.


Journal

Database : the journal of biological databases and curation
ISSN: 1758-0463
Titre abrégé: Database (Oxford)
Pays: England
ID NLM: 101517697

Informations de publication

Date de publication:
26 06 2021
Historique:
received: 09 03 2021
revised: 24 05 2021
accepted: 27 05 2021
pubmed: 26 6 2021
medline: 29 10 2021
entrez: 25 6 2021
Statut: ppublish

Résumé

We created a database of reconstructed patient-level data from published clinical trials that includes multiple time-to-event outcomes such as overall survival and progression-free survival. Outcomes were extracted from Kaplan-Meier (KM) curves reported in 153 oncology Phase III clinical trial publications identified through a PubMed search of clinical trials in breast, lung, prostate and colorectal cancer, published between 2014 and 2016. For each trial that met our search criteria, we curated study-level information and digitized all reported KM curves with the software Digitizelt. We then used the digitized KM survival curves to estimate (possibly censored) patient-level time-to-event outcomes. Collections of time-to-event datasets from completed trials can be used to support the choice of appropriate trial designs for future clinical studies. Patient-level data allow investigators to tailor clinical trial designs to diseases and classes of treatments. Patient-level data also allow investigators to estimate the operating characteristics (e.g. power and type I error rate) of candidate statistical designs and methods. Database URL: https://10.6084/m9.figshare.14642247.v1.

Identifiants

pubmed: 34169314
pii: 6309184
doi: 10.1093/database/baab037
pmc: PMC8234134
pii:
doi:

Banques de données

figshare
['10.6084/m9.figshare.14642247.v1']

Types de publication

Journal Article Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : NLM NIH HHS
ID : R01 LM013352
Pays : United States
Organisme : NIH HHS
ID : 1R01LM013352-01A1
Pays : United States

Informations de copyright

© The Author(s) 2021. Published by Oxford University Press.

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Auteurs

Geoffrey Fell (G)

Department of Data Science, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02115, USA.

Robert A Redd (RA)

Department of Data Science, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02115, USA.

Alyssa M Vanderbeek (AM)

Clinical Trials and Statistics Unit, Institute of Cancer Research, 123 Old Brompton Road, Sutton, London SW73RP, UK.

Rifaquat Rahman (R)

Department of Radiation Oncology, Harvard Medical School, 25 Shattuck St, Boston, MA 02115, USA.
Department of Radiation Oncology, Dana-Farber/Brigham and Women's Cancer Center, 450 Brookline Ave, Boston, MA 02215, USA.

Bill Louv (B)

Project Data Sphere, 1204 Village Market Place, Suite 288, Morrisville, NC 27560, USA.

Jon McDunn (J)

Project Data Sphere, 1204 Village Market Place, Suite 288, Morrisville, NC 27560, USA.

Andrea Arfè (A)

Department of Data Science, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02115, USA.
Department of Radiation Oncology, Harvard Medical School, 25 Shattuck St, Boston, MA 02115, USA.

Brian M Alexander (BM)

Department of Radiation Oncology, Harvard Medical School, 25 Shattuck St, Boston, MA 02115, USA.
Department of Radiation Oncology, Dana-Farber/Brigham and Women's Cancer Center, 450 Brookline Ave, Boston, MA 02215, USA.

Steffen Ventz (S)

Department of Data Science, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02115, USA.
Department of Biostatistics, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, USA.

Lorenzo Trippa (L)

Department of Data Science, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02115, USA.
Department of Biostatistics, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, USA.

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Classifications MeSH