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.
A research consortium including academic, pharmaceutical, and other stakeholders conducts a screening trial using a surrogate end point to identify a promising drug and biomarker. Replication of the surrogate end point during a confirmatory trial allows accelerated Food and Drug Administration (FDA) approval for the drug, and approval of the biomarker, while the trial continues through the clinical end point required for full FDA approval.
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