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

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Pharmaceutical Statistics (MBSW 2016)

Part of the book series: Springer Proceedings in Mathematics & Statistics ((PROMS,volume 218))

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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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Authors and Affiliations

  1. Takeda Pharmaceuticals Inc., Cambridge, MA, USA

    Greg Hather & Ray Liu

Authors
  1. Greg Hather
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  2. Ray Liu
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Correspondence to Greg Hather .

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Editors and Affiliations

  1. Statistical Innovation and Consultation group, Takeda Pharmaceuticals, Cambridge, MA, USA

    Ray Liu

  2. Division of Biometrics VI, CDER, U.S. Food and Drug Administration , Silver Spring, MD, USA

    Yi Tsong

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Hather, G., Liu, R. (2019). Project Data Sphere and the Applications of Historical Patient Level Clinical Trial Data in Oncology Drug Development. In: Liu, R., Tsong, Y. (eds) Pharmaceutical Statistics. MBSW 2016. Springer Proceedings in Mathematics & Statistics, vol 218. Springer, Cham. https://doi.org/10.1007/978-3-319-67386-8_19

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