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December 21, 2011

Accelerating Identification and Regulatory Approval of Investigational Cancer Drugs

Author Affiliations

Author Affiliations: University of California at San Francisco (Dr Esserman); and Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland (Dr Woodcock).

JAMA. 2011;306(23):2608-2609. doi:10.1001/jama.2011.1837

The development of new drugs is becoming increasingly expensive—and oncology drugs, in particular, have a high clinical failure rate.1,2 The current return on capital investment in drug development by US public companies was recently reported as less than 0.3%.3 The low probability of success, coupled with rapidly accelerating expenses, means that drug development is increasingly the purview of only 2 organization types: a few large companies and myriad small, venture capital–funded start-up firms. At an estimated cost of $1.0 billion to $1.8 billion for developing a successful new drug,4 funding for such risky ventures, particularly for oncology drugs, may diminish.