PDF: JAMA publishes Commentary about accelerating approval of new cancer treatments

The December 21, 2011 issue of the Journal of the American Medical Association includes a Commentary entitled “Accelerating Identification and Regulatory Approval of Investigational Cancer Drugs” authored by Dr. Laura Esserman, MD (and Principal Investigator of the I-SPY 2 Trial) and Janet Woodcock, Director of the Center for Drug Evaluation and Research of the FDA.

The Commentary starts by stating the problem with getting new drugs to market today – “The development of new drugs is becoming increasingly expensive—and oncology drugs, in particular, have a high clinical failure rate. The current return on capital investment in drug development by US public companies was recently reported as less than 0.3%. 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, funding for such risky ventures, particularly for oncology drugs, may diminish.”

The methodology behind the I-SPY 2 Trial is cited in this Commentary as one important example of how to dramatically speed up the process.