Statistical Challenges with the Advances in Cancer Therapies

Rajeshwari Sridhara ()
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Rajeshwari Sridhara: US Food and Drug Administration, Office of Biostatistics, Center of Drug Evaluation and Research

A chapter in Frontiers of Biostatistical Methods and Applications in Clinical Oncology, 2017, pp 11-20 from Springer

Abstract: 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 considerationsRegulatory consideration 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.

Keywords: Regulations; Cancer drug development paradigm; Immunotherapies (search for similar items in EconPapers)
Date: 2017
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-981-10-0126-0_2

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DOI: 10.1007/978-981-10-0126-0_2

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