At Verana Health, we’re continuously looking for ways to connect patients to clinical trials, but one of our employees recently found herself on the patient care side and decided to enroll in a clinical trial on her own.
Verana Health Site Engagement Manager, Gabe Goldfeder, sat down for a Q&A with Sonya Li, who is Verana Health’s Director of Strategic Partnerships, to learn more about her experience participating in a clinical trial.
Gabe: Can you briefly describe your role at Verana Health?
Sonya: I lead Strategic Partnerships that can grow and improve Verana Health’s business, with a focus on clinical trials. This includes data partners, technology platforms, provider networks, and trials organizations.
Gabe: Prior to joining Verana Health, what was the extent of your knowledge about clinical trials?
Sonya: I have a life sciences background, so I was generally familiar with the clinical development for pharmaceuticals and medical devices before joining Verana Health.
Gabe: What happened in your personal life that led you to consider enrolling in a trial (“the injury”)?
Sonya: I sustained a knee injury while qualifying for the Olympic ski team this winter. Joking aside, I took a tumble while skiing with friends in March 2023 and tore my ACL and meniscus.
Gabe: Can you provide an overview of the trial and the possible treatments you may receive?
Sonya: The study (BEAR III) is an interventional, open-label, prospective cohort study for a Bridge-Enhanced ACL Restoration (BEAR) implant. The implant was cleared by the FDA in 2020, and long-term studies like mine are ongoing. The goal of BEAR III is to assess age as a risk factor for BEAR restoration, and to evaluate the outcomes such as knee laxity, function, arthritis, and repair failure over 10 years of follow-up.
Gabe: Why did you decide to enter the trial, as opposed to receiving the standard of care treatment? Did your work at Verana Health influence your decision?
Sonya: I chose a trial for several reasons:
- Clinical trials are intended to test novel interventions that may potentially become the future’s standard of care. Joining a trial gives me early access to medicines and devices at the frontier of medicine.
- A trial can provide access to treatments not covered by insurance. In my case, the BEAR implant was not covered by my health plan because of its current evidence base, leading to high out-of-pocket costs. By enrolling, I hope to help generate the evidence needed for insurers to cover the implant more broadly in the future.
- The care received in clinical trials can be more thorough than routine practice. For instance, trial enrollment allowed me to get on the orthopedic surgeon’s operating schedule promptly. I had a whole team of fantastic clinical research coordinators (CRC) that coordinated visits, answered questions, and followed up. Over 10 years, I will also receive additional testing and imaging that will allow me to see the growth and restoration of my ACL.
My decision to enroll was very much influenced by working at Verana Health, where I have been introduced to many clinical research teams and investigators. My role at Verana Health also helped me appreciate the importance and value of clinical trials to patients.
Gabe: Has your experience with the trial, thus far, changed how you approach your job?
Sonya: Definitely. A few areas come to mind:
- Technology interoperability and workflow integration are critical. I have a new appreciation for the care coordination needed to get a trial candidate through informed consent, screening, surgery date, and follow-up. I worked with my orthopedic surgeon, 2 research coordinators, 2 schedulers, 2 radiologists, lab work department, 2 physical therapists, and multiple nurses. Building technology to improve clinical trials should contemplate the many stakeholders and existing processes/procedures that are painstakingly coordinated to ensure all details / requirements are met.
- Barriers to clinical trial access remain high. I was fortunate in that my background empowered me to research options and consider BEAR III. There were no trial sites in California, which led me to fly to New Jersey for treatment (shout out to Dr. Sean McMillan and CRC Donna Hoopes). For the everyday patient, the industry must bolster knowledge of ongoing trials, include geographically diverse trial sites, and consider “decentralized” visits (e.g., physical therapy, telehealth, electronic patient-reported outcomes) to reduce the barrier to entry.
- Patient experience has room for improvement. Tools that centralize information for patients can be tremendously helpful. I have a massive folder with all my referrals, appointments, patient questionnaires, medications, rehab instructions– this information can be consolidated into a single, friendly patient resource. However, a successful product will require collecting information from pharmacies, EHRs, scheduling, sponsors, and different providers.