The broad landscape of public health, and the specific domain of clinical trials, resonate with once-in-a-lifetime force in year 2 of COVID-19. Here, four PCOM alumni describe how their work and their workplaces are drawing on and pivoting from a pre-pandemic baseline to prepare themselves and those they serve for what may be next.
“In public health, the population is our patient,” says Lauren B. Ball, DO ’95, MPH, FAOCOPM, assistant professor, PCOM Georgia, and course director for the Preventive and Community-Based
Medicine course required for all Doctor of Osteopathic Medicine (DO) candidates. In that role, Dr. Ball’s mission is to “make public health concepts relevant
to students in whatever specialty of medicine they plan to pursue.”
From that perspective, the COVID-19 pandemic was an extraordinary teaching opportunity. “The concepts were playing out in real life, affecting the students and their families. We saw different approaches to the pandemic in different parts of the country, and still other approaches internationally. Disease control efforts involve elements of individual and social responsibility, which at times can conflict with personal freedoms.”
Dr. Ball describes public health as a balancing act, with science overlain by politics and economics, noting that “the public health response to an outbreak or pandemic continually evolves as we gather more information and allocate funding.”
Dr. Ball has herself been part of such responses. At the Centers for Disease Control and Prevention (CDC), she was in the Epidemic Intelligence Service, and her work as a staff member was supported by the beginning of the funding of public health preparedness. “Under the umbrella category of bioterrorism, we worked to bolster the essential activities that public health departments do every day: surveillance, lab testing, finding cases, tracing contacts, and recommending non-pharmaceutical interventions such as social distancing, quarantine and isolation.”
At the Florida Department of Health, Dr. Ball was involved in the mass vaccination response to the H1N1 influenza pandemic in 2009. Later, as the deputy state epidemiologist for the Maine Center for Disease Control, she worked on a response to a novel variant of swine influenza.
“I remind students,” Dr. Ball says, “that they are required to work with the public health department, as mandated by law, in managing cases of communicable disease. The health department is a resource for clinicians, providing important information in the form of health alerts and guidance documents that support communicating with patients about prevention measures that will impact personal health as well as the health of the community.
“Public health also deals with chronic disease,” she adds, “and it’s up to clinicians to help communicate with their patients about lifestyle changes that would impact their health.” Chronic disease and infectious disease can intersect; the morbidity and mortality related to COVID demonstrated the “disproportionate impact on those segments of the population that suffer from certain chronic diseases. The burden of disease was not spread equally, which also illustrated the impact of the social determinants of health, including access to care.”
Vaccine hesitancy has been widely discussed during the COVID pandemic. “Who better to give someone science-based information than their personal clinician?” Dr. Ball asks. She introduced her students to apps and websites that help clinicians frame such conversations, pointing out that evidence-based practices exist not only in medicine, but also in public and community health.
“Yes, we are in unprecedented times,” says Dr. Ball, “but we constantly learn from
our past responses about what worked and what didn’t. What we will learn from COVID
will help us plan for future events to be able to implement successful, timely interventions.”
In February 2020, the 15-year-old clinical trial research company IACT Health had 69 concurrently enrolling research trials in over 30 different medical therapeutic areas—oncology, nephrology, cardiology and more—but very little vaccine work or medical device work, and virtually no prescreening activities, like community health fairs.
“On March 13, 2020,” recalls Jeffrey Kingsley, DO ’01, MBA, CPI, FACRP, founder and CEO, “we got our first email saying, ‘Stop immediately. This trial is on hold until further notice.’ Within four weeks, 60 percent of our business had been suspended.”
The company invested in lab equipment and hired a new “swab squad” to do free COVID testing in their redesigned parking lot. In the process, they pivoted into new research areas and subsequently built out a new division around vaccine research and medical device research. They invested in doing more gastroenterology research to leverage the success of the COVID work.
Today, the company has over 120 concurrently enrolling trials and manages about 400 concurrent trials. But “our passionate cause,” says Dr. Kingsley, “is revolutionizing research. How do we get more physicians involved, more patients? How do we make research happen faster?”
COVID has dramatically accelerated industry interest in direct to patient clinical trials, also called decentralized or virtual clinical trials. Dr. Kingsley—despite having built a brick and mortar business—has long believed they are the future of research. “Why should I make you come to my building to be able to participate? The vast majority of patients who enter trials are within a five-mile radius of an office.”
As a result of the pandemic, “All of a sudden, we see home health nursing being able to facilitate getting patient bloodwork. All of a sudden, couriers can deliver a drug to a patient’s home and bring the labs back to us, we process the labs, and the courier does the shipping for us.”
In two vaccine projects currently enrolling throughout the United States, “patients will never have to meet me in person,” says Dr. Kingsley, “but I can jump on a call with them, or a telemedicine visit—for example, to help them understand the informed consent process. This dramatically enhances our ability to enroll those projects, and now patients in remote areas can participate, whereas they wouldn’t have had the opportunity otherwise.”
Patient availability isn’t the only challenge in clinical trial research. “Today there are too few experienced principal investigators (PIs),” says Dr. Kingsley. “The churn rate of physicians in clinical research is 51 percent—almost the same as waitstaff in a restaurant. Most sites are very small, poorly run businesses, with doctors still trying to do this as a hobby.
“The solution is to design a system that allows physicians to thrive doing research long-term as part of their career trajectory. Doing direct to patient work effectively means you need fewer PIs, because now one PI can serve an entire state. And so direct to patient enables us to more effectively access the greatest, most experienced PIs.”
“‘Necessity is the mother of invention’ is not quite true,” Dr. Kingsley observes. “Pain is the mother of invention. COVID was painful enough that it made the industry adopt direct to patient methods. And ultimately that’s the silver lining.”
Jacky So, MS/Biomed ’16, works at a company that didn’t exist before the pandemic. Mrs. So is director of technical program managers at Primary.Health in San Francisco, a cloud-based data platform startup focused on software solutions for testing and vaccination programs. Begun by a group of volunteers initially seeking to increase COVID-19 testing and tracing efforts in Northern California, the company has grown from eight people to over one hundred.
Mrs. So describes the platform as “lab agnostic, requisitioning physician agnostic, test agnostic—we enable any size group, organization, business, school, community, research lab, you name it, to use our platform. Our platform is modular and flexible, which allows us to adapt and customize the end-to-end process to their needs.” Primary.Health is committed to inclusivity and social determinants of health, both through their platform’s design and functionality and through their focus on providing services to areas of greatest need, including communities of color.
“How do we collect data not merely for the sake of collecting it,” asks Mrs. So, “but to actually bridge gaps in health equity resources?” For Mrs. So, it’s about providing seats at the table, in multiple ways.
Primary.Health thinks about the experience for both the administrator providing services and the end participant. For example, administrators might want updated insurance information if it exists, so they can enable a feature that allows collecting such information at the point of service. But Primary.Health “doesn’t prioritize insurance as a gatekeeping mechanism to deny somebody access to services they need. People move. People have lost their jobs during the pandemic, and their insurance is tied to their jobs. By allowing insurance to be secondary to what we do, we are able to prioritize the right things and serve as a conduit for groups to reach their populations of interest.
“Our research partners are doing multiyear longitudinal studies of communities that might not have great Wi-Fi or access to internet.
“Many research tools were built decades ago; everything’s just text. And if that text is English-only, it’s already excluded people before a study ever started. It also excludes people on the patient end, who might have to call a helpline, resulting in a backlog of calls—it’s a broken system, but it just keeps being done that way. And so that’s where we enter.”
The company can visualize data of interest and generate highly customized reports—maybe one way for a study, a different way for a lab, for a board of directors, to meet federal reporting requirements. “We support multiple languages and translations, and every group, every study, has custom needs,” says Mrs. So.
During the winter holiday season, Mrs. So saw a support ticket for an airline passenger trying to fly home to Hong Kong. The airline wanted a lab report PDF, which the lab needed to generate ad hoc but wasn’t permitted to send by email. Mrs. So “coded something up and got the signoff from the lab”—transitioning the manual lab report generation into an automated custom report on the patient’s secured results page that even included specific terms the airline wanted. “I learned later that everyone else was stuck at the airport because their lab reports did not show the specific items we were able to include, but we helped that person get home. Thanks to this collaboration during peak travel and varying country restrictions, the auto-generated lab reports during this time have been self-sustaining to help others as well.”
As the U.S. emerges from the pandemic, Primary.Health “can package what we’ve done to support other research efforts and countries,” says Mrs. So. “If we look around the world, it’s going to take all of us to move the future of data, science and equity forward.”
Digest, the magazine for alumni and friends of Philadelphia College of Osteopathic Medicine, is published by the Office of Marketing and Communications. The magazine reports on osteopathic and other professional trends of interest to alumni of the College’s Doctor of Osteopathic Medicine (DO) and graduate programs at PCOM, PCOM Georgia and PCOM South Georgia.
© 2024 Philadelphia College of Osteopathic Medicine