Model-based predictions of expected anti-tumor response and survival in phase III studies based on phase II data of an investigational agent.

@article{Claret2006ModelbasedPO,
  title={Model-based predictions of expected anti-tumor response and survival in phase III studies based on phase II data of an investigational agent.},
  author={Laurent Claret and Pascal Girard and Joyce O'Shaughnessy and Paulo Marcelo Gehm Hoff and Eric Van Cutsem and Joanne L. Blum and K Zuideveld and Karin Jorga and Jan Fagerberg and Rene Bruno},
  journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology},
  year={2006},
  volume={24 18_suppl},
  pages={6025}
}
6025 Background: Decision making during early oncology drug development remains very empirical. A drug-disease simulation model to predict expected clinical response and survival in phase III studies from observed longitudinal tumor size in phase II trials offers a science-based alternative. METHODS We developed the following: 1) longitudinal exposure-response models of drug effect (and resistance) on tumor growth dynamics based on phase II data on capecitabine (X) in metastatic breast (MBC… CONTINUE READING

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