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Drug Development, Trial Design, and Endpoints in Oncology: Adapting to Rapidly Changing Science
Author(s) -
Blumenthal GM,
Goldberg KB,
Pazdur R
Publication year - 2017
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.623
Subject(s) - drug development , food and drug administration , clinical trial , medicine , drug approval , transformative learning , drug , regulatory science , oncology , cancer drugs , clinical oncology , intensive care medicine , cancer , pharmacology , psychology , pathology , pedagogy
As a result of enhanced understanding of genetic and immunologic underpinnings of cancer, there has been progress in development of targeted and immunotherapies in oncology. The traditional linear sequential model of drug development has evolved. Early clinical trials of breakthrough therapies often include expansion cohorts, termed "seamless drug development." The US Food and Drug Administration (FDA) uses expedited programs, such as breakthrough designation and accelerated approval ensuring that transformative therapies are available to patients earlier in the cycle of evidence generation.