“This is one of the things that excites me most about clinical trials,” says Stephanie Farrell, MBA, RN, CCRC, CPHQ, Director of Research Administration. “Clinicians and patients can get early access to drugs that aren’t yet FDA-approved, and for conditions for which there aren’t yet any treatments, in a safe and carefully monitored setting.”
Notably, in June 2020 — early in the pandemic — Eisenhower was involved in the first industry-sponsored clinical trial treating patients with mild to moderate COVID-19 using an infusion of monoclonal antibodies to determine if this could prevent disease progression and hospitalization. At the same time, Eisenhower partnered with the National Institute of Allergy and Infectious Diseases on a second trial, also using monoclonal antibodies to treat mild to moderate COVID-19 in high-risk patients who were immunocompromised, older, overweight, or who had heart conditions.
As the data came in over the next few months, it revealed that this treatment was delivering the hoped-for results — a bright spot at a very dark time.
“We applied for emergency use authorization from the FDA to use monoclonal antibodies outside the clinical trial setting,” Farrell relates. “We just needed the physical space and equipment to assess and infuse patients.” It had to be a negative pressure room ? also called an isolation room ? to ensure the safety of non-COVID-19 patients in the hospital.
“I talked to Marty (Martin Massiello, President and Chief Executive Officer of Eisenhower Health) about this at 6 a.m. one day in December,” Farrell says. “By 10 p.m. that night the clinic had been designed, built and equipped, and we treated our first patient the next morning.”
In subsequent weeks, Kenneth Lichtenstein, MD, Board Certified in Internal Medicine and Infectious Disease, and his team treated more than 1,200 patients in this outpatient infusion center. “We were able to hit the ground running because Dr. Lichtenstein had experience with the Covid clinical trials we’d done in the months prior,” Farrell notes.
On the inpatient side, Eisenhower was involved in a COVID-19 convalescent plasma study in partnership with the Mayo Clinic. This involved taking antibody-rich plasma from patients who had recovered from COVID-19 and using it in severely ill ICU patients to help boost their immune response. This study was led by Anil Perumbeti, MD, Board Certified in Critical Care Medicine and Pulmonary Disease, who was treating COVID-19 patients in the hospital.
“It was a harrowing time,” Farrell says. “We were seeing unprecedented numbers of people needing care while we coped with extreme staffing shortages. But we were able to obtain FDA approval for expanded access to offer convalescent plasma to Covid inpatients outside the clinical trial.”
In addition to these important COVID-19 clinical trials, Eisenhower Health has opened numerous other studies in the past two years. In fact, as of September 2022, the organization has nearly 100 active research studies and clinical trials underway.
In interventional cardiology, for example, Chanaka Wickramasinghe, MD, is evaluating a pulmonary artery sensor for use in patients with class 3 heart failure to help detect when patients are having an exacerbation before major clinical symptoms appear. And Andrew Frutkin, MD, is investigating the treatment of moderate aortic stenosis with transcatheter aortic valve replacement (TAVR).
“Many times, we’re testing devices, drugs or procedures already FDA-approved for more severe conditions, as these two interventions are,” Farrell says. “The new studies seek to determine if those with less-severe disease will also benefit.”
In infectious disease, Ann Stapleton, MD, a highly experienced, federally funded researcher specializing in HIV and urinary tract infections (UTIs), joined Eisenhower Health in 2017. In addition to expanding clinical trials in these areas, she is program director of Eisenhower’s Infectious Disease fellowship program, providing knowledge transfer and training to the next generation of clinical experts.
Additionally, new clinical trials have opened in Neurology (looking at new treatments for challenging neurological disorders), orthopedics (studying new systems for total ankle replacement and total knee replacement), and nterventional pulmonology (including a study collecting clinical information about robotic-assisted bronchoscopy in order to advance care and outcomes).
In oncology, Eisenhower continues to provide more opportunities for valley residents to participate in groundbreaking clinical trials through an affiliation with UC San Diego Health Cancer Network, where more than 200 studies are underway at any one time. These include major multicenter trials run by national cooperative groups as well trials initiated by UC San Diego Health investigators that aren’t available anyplace else in the world. Importantly, eligible patients can participate in these trials without leaving the desert.
Most of the cancer clinical trials are studying the effectiveness of novel targeted therapies and immunotherapies for treating various cancers including lung, breast, endometrial and multiple myeloma. These newer treatments often cause fewer side effects than chemotherapy.
“We are doing more and more clinical trials at Eisenhower, led by ultra-engaged physician-investigators who are committed to advancing science and discovering new treatments to help deliver better outcomes for patients,” Farrell says. “That’s what every investigator — and patient — is doing when they participate in research and clinical trials.”