1. KMDATA: a curated database of reconstructed individual patient-level data from 153 oncology clinical trials
- Author
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Jon McDunn, Bill Louv, Lorenzo Trippa, Brian M. Alexander, Geoffrey Fell, Robert A. Redd, Rifaquat Rahman, Andrea Arfè, Alyssa M Vanderbeek, and Steffen Ventz
- Subjects
Male ,Oncology ,medicine.medical_specialty ,Databases, Factual ,MEDLINE ,Kaplan-Meier Estimate ,Medical Oncology ,computer.software_genre ,General Biochemistry, Genetics and Molecular Biology ,03 medical and health sciences ,0302 clinical medicine ,Neoplasms ,Internal medicine ,medicine ,Overall survival ,Humans ,030212 general & internal medicine ,Survival analysis ,Database ,Extramural ,business.industry ,Clinical trial ,Patient level data ,030220 oncology & carcinogenesis ,AcademicSubjects/SCI00960 ,Original Article ,General Agricultural and Biological Sciences ,business ,computer ,Information Systems ,Type I and type II errors - 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
- Published
- 2021