Before New Orleans-based Ochsner Health System’s effort to bring phase 1 and phase 2 clinical trials to patients in Louisiana, Mississippi, and the Florida Panhandle, people in these areas had no local options for access to these types of innovative therapies.
“[Early-stage clinical trials] aren’t experiments on guinea pigs,” says Marc Matrana, MD, medical director of Ochsner’s precision cancer therapies program. . He insists that early-stage clinical trials are the standard of care and offer patients another opportunity of hope against the disease. Thus, it’s important for oncologists to enroll their patients in clinical trials and for patients to inquire more about them.
To provide patients with local access to early-stage clinical trials, in early 2017, Ochsner partnered with Phoenix-based Translational Genomics Research Institute, a nonprofit that uses diagnostics and targeted therapeutics to improve disease outcomes.
Matrana’s team won an Association of Community Cancer Centers (ACCC) Innovator Award for their work bringing early-stage clinical trials to cancer patients.
What attracted Matrana to the Translational Genomic Research Institute was the experience of Daniel Von Hoff, MD, the nonprofit’s physician-in-chief and director of translational research. “Dr. Daniel Von Hoff has more phase 1 clinical trial experience than anyone,” he adds.
That experience allowed Ochsner to ramp up relatively quickly with the support of the research institute’s infrastructure, which includes both the staff and insight into using precision medicine to better select therapies for Ochsner’s patients.
Matrana’s team also values the research institute’s network of contacts in the clinical trials, knowledge of the science behind clinical trials, and relationships with drug companies.
Since the start of the program in April 2017, Ochsner has been involved in 50 early-stage clinical trials with partners such as:
- Nektar Therapeutics in San Francisco, which uses a novel immune approach to treat bladder cancers and other malignancies without chemotherapy.
- Woburn, Massachusetts-based Mitra Biotech, whose CANscript platform provides tumor sensitivity testing. Allowing providers to grow patient tumors in a lab and test multiple therapies in advance; this helps providers determine the appropriate therapy for a patient before treatment
- Strata Oncology in Ann Arbor, Michigan, which provides free-of-charge next-generation gene sequencing to stage 3 and Istage 4 solid tumor and lymphoma patients at Ochsner
Ochsner takes advantage of a Louisiana law that requires payers to cover the cost of patient care during clinical trials. As a result, patients have greater access to clinical trials than in other states, he says.
For providers in states that don’t require coverage for patients in clinical trials, Matrana recommends having an open dialog with payers and the pharmaceutical industry. Often, when a payer can’t cover something for a patient, the pharmaceutical company is willing to help increase access to the treatment, he adds.
Still, there are a lot of things providers need to learn regarding early-phase clinical trials, according to Matrana. He highlights the following expertise:
- Regulatory burdens, such as the paperwork involved when working with the FDA and clinical trial sponsors.
- Practical considerations, including the temperature at which drugs must be stored.
- The expertise to contract with research organizations.
- Legal and accounting teams engaged on contracts and budgets.
- Engagement with in-house clinical providers.
Ochsner has 30 team members involved in its clinical trials efforts. Creating operating mechanisms—such as a weekly organizational meeting among the entire team—helps keep all the team members aware of each patient’s health status. That enables Ochsner to recognize and address any issues early during the patient experience, says Matrana.
It’s important to increase ethnic diversity in clinical trials. That’s because cancer manifests differently in patients of different ethnic backgrounds.
Southeast Louisiana, especially New Orleans, is one of the most ethnically and racially diverse regions in the country, says Matrana. Sixty-six percent of New Orleans’ population is non-white, according to the U.S. Census.
“Our research patients represent our population at large and include a very large number of ethnic minorities and racially diverse patients,” he adds.
Aine Cryts is a writer based in Boston.