Clinical Trials and PIs | Reimagining Public Health Post-COVID

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DIGEST MAGAZINE

    Reimagining Public Health 
    Pivoting from Pandemic Response to Future Prevention


    July 6, 2021

    by Janice Fisher

    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 黑料传送门 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.

    Graphic art of physician wrestling with burnout during the COVID-19 pandemic鈥淚n public health, the population is our patient,鈥 says Lauren B. Ball, DO 鈥95, MPH, FAOCOPM, assistant professor, 黑料传送门 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鈥檚 mission is to 鈥渕ake public health concepts relevant to students in whatever specialty of medicine they plan to pursue.鈥

    From that perspective, the COVID-19 pandemic was an extraordinary teaching opportunity. 鈥淭he 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.鈥

    A balancing act

    Dr. Ball describes public health as a balancing act, with science overlain by politics and economics, noting that 鈥渢he public health response to an outbreak or pandemic continually evolves as we gather more information and allocate funding.鈥

    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. 鈥淯nder 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.鈥

    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.

    Public health concepts for DO students

    鈥淚 remind students,鈥 Dr. Ball says, 鈥渢hat 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.

    鈥淧ublic health also deals with chronic disease,鈥 she adds, 鈥渁nd it鈥檚 up to clinicians to help communicate with their patients about lifestyle changes that would impact their health.鈥 Chronic disease and infectious disease can intersect; the morbidity and mortality related to COVID demonstrated the 鈥渄isproportionate 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.鈥

    Vaccine hesitancy has been widely discussed during the COVID pandemic. 鈥淲ho better to give someone science-based information than their personal clinician?鈥 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.


    Graphic art of physician taking notes during the COVID-19 pandemic鈥淵es, we are in unprecedented times,鈥 says Dr. Ball, 鈥渂ut we constantly learn from our past responses about what worked and what didn鈥檛. What we will learn from COVID will help us plan for future events to be able to implement successful, timely interventions.鈥

    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鈥攐ncology, nephrology, cardiology and more鈥攂ut very little vaccine work or medical device work, and virtually no prescreening activities, like community health fairs.

    鈥淥n March 13, 2020,鈥 recalls Jeffrey Kingsley, DO 鈥01, MBA, CPI, FACRP, founder and CEO, 鈥渨e got our first email saying, 鈥楽top immediately. This trial is on hold until further notice.鈥 Within four weeks, 60 percent of our business had been suspended.鈥

    The company invested in lab equipment and hired a new 鈥渟wab squad鈥 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 鈥渙ur passionate cause,鈥 says Dr. Kingsley, 鈥渋s revolutionizing research. How do we get more physicians involved, more patients? How do we make research happen faster?鈥

    The future of research: Direct to patient

    COVID has dramatically accelerated industry interest in direct to patient clinical trials, also called decentralized or virtual clinical trials. Dr. Kingsley鈥攄espite having built a brick and mortar business鈥攈as long believed they are the future of research. 鈥淲hy 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.鈥

    As a result of the pandemic, 鈥淎ll 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鈥檚 home and bring the labs back to us, we process the labs, and the courier does the shipping for us.鈥

    In two vaccine projects currently enrolling throughout the United States, 鈥減atients will never have to meet me in person,鈥 says Dr. Kingsley, 鈥渂ut I can jump on a call with them, or a telemedicine visit鈥攆or 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鈥檛 have had the opportunity otherwise.鈥

    Solving the program of too few PIs

    Patient availability isn鈥檛 the only challenge in clinical trial research. 鈥淭oday there are too few experienced principal investigators (PIs),鈥 says Dr. Kingsley. 鈥淭he churn rate of physicians in clinical research is 51 percent鈥攁lmost 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.

    鈥淭he 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.鈥

    鈥溾楴ecessity is the mother of invention鈥 is not quite true,鈥 Dr. Kingsley observes. 鈥淧ain is the mother of invention. COVID was painful enough that it made the industry adopt direct to patient methods. And ultimately that鈥檚 the silver lining.鈥


    Jacky So, MS/Biomed 鈥16, works at a company that didn鈥檛 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 鈥渓ab agnostic, requisitioning physician agnostic, test agnostic鈥攚e 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.鈥 Primary.Health is committed to inclusivity and social determinants of health, both through their platform鈥檚 design and functionality and through their focus on providing services to areas of greatest need, including communities of color.

    Seats at the table

    鈥淗ow do we collect data not merely for the sake of collecting it,鈥 asks Mrs. So, 鈥渂ut to actually bridge gaps in health equity resources?鈥 For Mrs. So, it鈥檚 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 鈥渄oesn鈥檛 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.

    鈥淥ur research partners are doing multiyear longitudinal studies of communities that might not have great Wi-Fi or access to internet.

    鈥淢any research tools were built decades ago; everything鈥檚 just text. And if that text is English-only, it鈥檚 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鈥攊t鈥檚 a broken system, but it just keeps being done that way. And so that鈥檚 where we enter.鈥

    Customizing and moving forward

    The company can visualize data of interest and generate highly customized reports鈥攎aybe one way for a study, a different way for a lab, for a board of directors, to meet federal reporting requirements. 鈥淲e support multiple languages and translations, and every group, every study, has custom needs,鈥 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鈥檛 permitted to send by email. Mrs. So 鈥渃oded something up and got the signoff from the lab鈥濃攖ransitioning the manual lab report generation into an automated custom report on the patient鈥檚 secured results page that even included specific terms the airline wanted. 鈥淚 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.鈥

    As the U.S. emerges from the pandemic, Primary.Health 鈥渃an package what we鈥檝e done to support other research efforts and countries,鈥 says Mrs. So. 鈥淚f we look around the world, it鈥檚 going to take all of us to move the future of data, science and equity forward.鈥

    About Digest Magazine

    Digest, the magazine for alumni and friends of 黑料传送门, 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鈥檚 Doctor of Osteopathic Medicine (DO) and graduate programs at 黑料传送门, 黑料传送门 Georgia and 黑料传送门 South Georgia.

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