Patients fighting life-threatening illnesses who have run out of conventional options will get a chance to try some of the most cutting-edge treatments available, through a national effort that just received nearly $4.8 million in funding from the federal government.
Duke investigators have partnered with other CTSA institutions, the University of Michigan, the University of Texas Southwestern Medical Center, and the University of Rochester, on the Transforming Expanded Access to Maximize Support and Study (TEAMSS) project, which will build an infrastructure to help more hospitals offer experimental options to their patients and gather data on the impact.
“The goal is to get a potentially lifesaving therapy to a patient in need,” said Amanda Parrish, PhD, Director of Duke Office of Regulatory Affairs and Quality (ORAQ). “Duke was tapped to be a part of this project because of our existing processes for expanded access to investigational products.”
For the past year, ORAQ has been supporting Duke physicians interested in using non-FDA approved therapies in scenarios where such a treatment is appropriate. Parrish and her team provide the regulatory expertise and oversight to take administrative burden off of the physicians and ensure that rigorous ethical standards are met.
"The goal is to get a potentially lifesaving therapy to a patient in need."
-Amanda Parrish, PhD
Now they’re bringing that experience to this national effort.
“As regulatory professionals, we’re very familiar with this process. We do it every day,” said Erika Segear Johnson, PhD, Associate Director of Regulatory Affairs at ORAQ. “We can reach the ultimate target of making investigational products available to patients by building this infrastructure. We also have a chance to create a consistent dataset on the safety of these products.”
With the University of Michigan coordinating, the four partners in the new national consortium will act as hubs and reach out to hospitals in their area to help clinicians understand how they can bring patients forward for potential Expanded Access treatment after they’ve exhausted other options.
They also plan to work with industry partners and university spinoff companies to identify products that could be used outside of clinical trials and commercial production.
This project is funded by the National Center for Advancing Translational Sciences (NCATS), which is part of the National Institutes of Health (NIH). Duke, the University of Michigan, and the University of Rochester are part of NIH's national CTSA consortium.
Portions of this report were adapted from a University of Michigan press release. View the full release here.