Seamless Oncology-Drug Development

2016138 citationsJournal Article

Authors

Tatiana M. Prowell · Center for Drug Evaluation and Research

Marc R. Theoret · Center for Drug Evaluation and Research

Richard Pazdur · Food and Drug Administration

Abstract

Interview with Dr. Alice Shaw on a new model for accelerating the development of promising oncology drugs. (10:06)Download Increasingly, firms developing cancer drugs are forgoing standard phased development for a seamless approach of adding cohorts to a first-in-human trial to study doses and activity in various cancers. Key regulatory interactions and protections may therefore be missing.

Topics & Keywords

Science, Research, and Medicine Health Systems, Economic Evaluations, Quality of Life Biomedical Ethics and Regulation

UN Sustainable Development Goals

Partnerships for the goalsIndustry, innovation and infrastructure

Publication Details

Published in: New England Journal of Medicine

Volume 374, Issue 21, pp. 2001-2003

DOI: 10.1056/nejmp1603747

Field-Weighted Citation Impact: 31.94