JAMA
306
:
2608-2609
2011
.

Accelerating identification and regulatory approval of investigational cancer drugs.

Esserman LJ, Woodcock J

[Excerpt]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 pub- lic 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 pur- view of only 2 organization types: a few large companies and myriad small, venture capital–funded start-up firms. At an es- timated cost of $1.0 billion to $1.8 billion for developing a suc- cessful new drug,4 funding for such risky ventures, particu- larly for oncology drugs, may diminish.

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