Patient-Reported Outcomes in Cancer Drug Development/US Regulatory Review

JAMA Oncology 

 Patient-Reported Outcomes in Cancer Drug Development and US Regulatory ReviewPerspectives From Industry, the Food and Drug

 Data reported directly by patients about how they feel and function are rarely included in oncology drug labeling in the United States, in contrast to Europe and to nononcology labeling in the United States, where this practice is more common. Multiple barriers exist, including challenges unique to oncology trials, and industry’s concerns regarding cost, logistical complexities.....