Drug Development, Trial Design, and Endpoints in Oncology:

Clin. Pharmacol. Ther. · May 2017

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Drug Development, Trial Design, and Endpoints in Oncology: Adapting to Rapidly Changing Science.

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.

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- G M Blumenthal, K B Goldberg, and R Pazdur.
- Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
- Clin. Pharmacol. Ther. 2017 May 1; 101 (5): 572-574.
AbstractAs 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.Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

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