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Statistical Challenges with the Advances in Cancer Therapies

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Frontiers of Biostatistical Methods and Applications in Clinical Oncology

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Abstract

Statistical challenges in designing, analyzing and interpreting the data are being encountered with the recent development of new classes of drugs to treat cancer. The existing paradigm of drug development from Phase I to Phase III clinical trials is not optimal. New and innovative trial designs and statistical methods are needed to evaluate the new classes of drugs. In this chapter we present the regulatory considerations in the evaluation of drug products, the drug development paradigm in the last century and the current time, and the statistical challenges that need to be addressed.

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Author information

Authors and Affiliations

  1. Office of Biostatistics, Center of Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, 20993, USA

    Rajeshwari Sridhara

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  1. Rajeshwari Sridhara
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Correspondence to Rajeshwari Sridhara .

Editor information

Editors and Affiliations

  1. Graduate School of Medicine, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan

    Shigeyuki Matsui

  2. Cancer Research and Biostatistics, Seattle, Washington, USA

    John Crowley

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Sridhara, R. (2017). Statistical Challenges with the Advances in Cancer Therapies. In: Matsui, S., Crowley, J. (eds) Frontiers of Biostatistical Methods and Applications in Clinical Oncology. Springer, Singapore. https://doi.org/10.1007/978-981-10-0126-0_2

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