US FDA Commissioner Pushes Real-World Evidence To Guide Use Of Alzheimer’s, Obesity Drugs

The “biggest area” where FDA Commissioner Rob Califf believes real-world evidence will “make a difference” is in the post-market phase, “where there are all kinds of issues that often involve other parts of the ecosystem.” He pointed to drug developers’ new focus on Alzheimer’s disease and obesity: “we’ve got these enormous markets” and significant patient need. “Do we really know exactly who should get the treatment?”

During a Friends of Cancer Research meeting on 11 September, Califf pointed specifically to Accelerated Approval as an example of where RWE can be useful: Until recently, Accelerated Approvals were mostly in cancer and