Between 2009 and 2012, most newly approved therapeutics had at least 1 postapproval trial evaluating safety or efficacy. However, only 12% of the trials studied first FDA-approved indications, and more than 60% focused on unapproved or supplemental indications. Most were nonrandomized and uncontrolled, and more than one-third focused on a surrogate marker of efficacy rather than a clinical end point. (Cancer Therapy Advisor)