The FDA has launched its first two real-time clinical trials in partnership with Houston-based University of Texas MD Anderson Cancer Center, Philadelphia-based University of Pennsylvania, AstraZeneca, Amgen and Paradigm Health.
The real-time clinical trial model allows the FDA to review safety signals as the trial is being conducted “in a way that enhances safety monitoring and radically increases efficiency,” according to an April 28 news release from the FDA.
The announcement comes at a time when clinical trials have increasingly become a core component of oncology care delivery, forcing health systems that opt to participate to face the challenge of not only identifying eligible patients but also enrolling and supporting them throughout the trial journey.
AstraZeneca is conducting a phase 2 multi-site trial for treatment-naïve mantle cell lymphoma with MD Anderson and the University of Pennsylvania. Amgen will conduct a phase 1b trial for patients with limited-stage small cell lung carcinoma pending final site selection.
The FDA also released a request for information on a proposed real-time clinical trial pilot program. Comments will be accepted until May 29, with final pilot selections expected to be completed in August.
Leaders from New York City-based Memorial Sloan Kettering Cancer Center, Boston-based Massachusetts General Hospital and Stanford (Calif.) University recently called for increased efficiency and innovation of drug discovery and development in the U.S.
At the Becker's Perioperative Summit, taking place September 14–15 in Chicago, perioperative leaders and healthcare executives will focus on improving operating room efficiency, enhancing patient safety, optimizing staffing and driving innovation across surgical services. Apply for complimentary registration now.
