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Statistical Considerations in Setting Quality Specification Limits Using Quality Data Read chapter Read first chapter

2019 | OriginalPaper | Chapter

Project Data Sphere and the Applications of Historical Patient Level Clinical Trial Data in Oncology Drug Development

Authors : Greg Hather, Ray Liu

Published in: Pharmaceutical Statistics

Publisher: Springer International Publishing

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Abstract

As scientific data sharing initiatives become more popular, an increasing amount of oncology clinical trial data is becoming available to the public. This historical data has the potential to help improve the design and analysis of future studies of new oncology compounds. Project Data Sphere is one such public database of oncology studies, with patient level data from over 76,000 patients. Here, we review the contents of this database and describe several examples of how the data has been used or could potentially be used in drug development. Applications include population selection, historical comparisons, and identification of stratification factors.

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Metadata
Title
Project Data Sphere and the Applications of Historical Patient Level Clinical Trial Data in Oncology Drug Development
Authors
Greg Hather
Ray Liu
Copyright Year
2019
Book
Pharmaceutical Statistics

Print ISBN: 978-3-319-67385-1

Electronic ISBN: 978-3-319-67386-8

Copyright Year: 2019

DOI
https://doi.org/10.1007/978-3-319-67386-8_19

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