Evidence map›Paper›PMID 34169314›Full record

ArticleDatabase : the journal of biological databases and curation2021

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

Geoffrey Fell, Robert A Redd, Alyssa M Vanderbeek, Rifaquat Rahman, Bill Louv, Jon McDunn, Andrea Arfè, Brian M Alexander, Steffen Ventz, Lorenzo Trippa

Abstract read
In one paragraph

Article in Database : the journal of biological databases and curation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

10 authors.

Geoffrey FellDepartment of Data Science, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02115, USA.ORCID 0000-0001-6436-6691
Robert A ReddDepartment of Data Science, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02115, USA.
Alyssa M VanderbeekClinical Trials and Statistics Unit, Institute of Cancer Research, 123 Old Brompton Road, Sutton, London SW73RP, UK.
Rifaquat RahmanDepartment of Radiation Oncology, Harvard Medical School, 25 Shattuck St, Boston, MA 02115, USA.ORCID 0000-0002-9443-1797
Bill LouvProject Data Sphere, 1204 Village Market Place, Suite 288, Morrisville, NC 27560, USA.
Jon McDunnProject Data Sphere, 1204 Village Market Place, Suite 288, Morrisville, NC 27560, USA.
Andrea ArfèDepartment of Data Science, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02115, USA.
Brian M AlexanderDepartment of Radiation Oncology, Harvard Medical School, 25 Shattuck St, Boston, MA 02115, USA.
Steffen VentzDepartment of Data Science, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02115, USA.ORCID 0000-0003-2229-9560
Lorenzo TrippaDepartment of Data Science, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02115, USA.

Funding

Statistical Methods and Validation Analyses for the Integration of External Data in Clinical TrialsR01LM013352 · NLM · DANA-FARBER CANCER INST · PI TRIPPA, LORENZO · 2021 to 2024
$1.5M
NIH HHS 1R01LM013352-01A1NLM NIH HHS R01 LM013352
6 · The paper itself

Abstract

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.

Indexed as

NeoplasmsDatabases, FactualHumansKaplan-Meier EstimateMaleMedical Oncology

Identifiers

PMID34169314
PMCPMC8234134

What OpenQuestion holds

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Registered trials

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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.