TEAMSS Team Finds That Use of and Support for ‘Expanded Access’ is Widespread

The Transforming Expanded Access to Maximize Support and Study (TEAMSS) team recently published an article in the Journal of Clinical and Translational Science (JCTS) entitled, “National landscape assessment of academic medical center support for expanded access to investigational products.”

Expanded Access (EA) provides a pathway for the clinical use of investigational products (drugs, biologics, and medical devices) for patients who are without satisfactory therapeutic options and for whom a clinical trial is not available.

The team found that use of and support for EA is widespread at Academic Medical Centers, with support focused on single-patient requests. Gaps in support are common for activities after initial submission, such as FDA reporting and data collection.

MICHR’s Misty Gravelin was the lead author, along with Laurie Rigan, George Mashour, and Kevin Weatherwax. TEAMSS, funded by an NIH grant and led by MICHR, includes the University of Rochester Medical Center, Duke University School of Medicine, and University of Texas Southwestern Medical Center.

Read the full published article here.