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).
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.
Esserman LJ, Woodcock J. Accelerating Identification and Regulatory Approval of Investigational Cancer Drugs. JAMA. 2011;306(23):2608–2609. doi:10.1001/jama.2011.1837