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.
Some tools below are only available to our subscribers or users with an online account.
Download citation file:
Web of Science® Times Cited: 15
Customize your page view by dragging & repositioning the boxes below.
More Listings atJAMACareerCenter.com >
Enter your username and email address. We'll send you a link to reset your password.
Enter your username and email address. We'll send instructions on how to reset your password to the email address we have on record.
Athens and Shibboleth are access management services that provide single sign-on to protected resources. They replace the multiple user names and passwords necessary to access subscription-based content with a single user name and password that can be entered once per session. It operates independently of a user's location or IP address. If your institution uses Athens or Shibboleth authentication, please contact your site administrator to receive your user name and password.