Drs. Mark McClellan and Gregory Daniel of the Duke-Margolis Center for Health Policy describe ways to increase evidence development for off-label drugs in oncology. They outline two pathways by which evidence development has been explored, through the ASCO TAPUR study and the MED-C study. The ASCO TAPUR study includes patients who had exhausted all options and had advanced cancer. The MED-C study includes newly diagnosed patients who received standardized molecular testing covered by Medicare, and were then passed on to the appropriate clinical trial.
McClellan and Daniel note that the usefulness of the data collected from these studies depends on how we address target population, test payment, and data sharing, among others. Moving forward, they call for the development of pilot programs during initiative development and stakeholders who can appropriately interpret results and translate them into design proposals.
Read more in “Improving evidence developed from poplation-level experience with targeted agents.” Clinical Pharmacology and Therapeutics