Expanded Access Programs give patients the opportunity to try new therapies and treatments

Expanded Access Programs give patients the opportunity to try new therapies and treatments

Community Health System is bringing new treatments and therapies to patients through Expanded Access Programs.

When a patient has reached a point in the healing journey where their course of treatment is no longer effective, they may be eligible for what's known as a compassionate use opportunity or expanded access.

"So perhaps a patient with breast cancer has exhausted all other clinical options. In that scenario we may not have a clinical trial they're fully eligible for, or that fits their specific situation," said Cynthia Ho, Executive Director, Office of Research, Community Health System. "That's where we can either work with the pharmaceutical or device company to provide them an opportunity that's outside of that scope."

Another key benefit to Expanded Access Programs is that they can bring newly approved medications to patients faster, preventing a delay in treatment.

"Sometimes a drug has already been approved by the FDA [Food and Drug Administration] but mass production isn't quite there yet," said Ho. "An Expanded Access Program can fulfill that gap so that if a patient is in need, we don't delay medical care just because the regulatory portions haven't been established."

Protections for patients

While the FDA provides authority externally for Expanded Access use, Community's own Institutional Review Board is responsible for making sure patients are well informed and protected throughout the process.

"The Institutional Review Board's sole priority is to protect our patients from any sort of unethical conduct related to research or investigational products," said Ho.

This means following a protocol and plan in collaboration with the pharmaceutical or device company, making sure the patient has as much information as possible, and allowing the patient to change their mind at any time.

"It's important to know that everything is completely voluntary," said Ho. "A patient does not have to move forward with anything, and they can change their mind even after one dose."

Expanded Access offers more treatment closer to home

Having Expanded Access Programs available at Community means patients with life-threatening conditions don't have to travel to the Bay Area, Sacramento or Los Angeles. They can receive greater access to care locally, keeping them close to family and loved ones.

"Our patients are going through more than enough to begin with," said Ho. "Let's remove one more barrier."

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