In December 2019, the rumblings of a virus meandering its way through Wuhan province in China slowly made their way to Western airways. Little attention was paid to its steady spread until it had permeated the globe and halted life as we know it in a few short months. Suddenly, healthcare systems faced immense challenges that required massive overhauls of care delivery. Manufacturing grinded to a halt, affecting supply chains of vital medical equipment and medication. We also witnessed concerning and remarkably consistent reductions in hospital admissions for heart attacks, strokes, and heart failure across the globe; the New York Times asked, “Where have all the heart attacks gone?”
The COVID-19 pandemic has also shaken up clinical research. Typical clinical trial development programs that would often take years of planning were initiated in a matter of days, as researchers rushed to offer a glimmer of hope. Sponsors and investigators of ongoing large clinical trials were quickly forced to adapt protocols to ensure that study treatment was reaching patients in timely ways and that data could be collected in ways that were safe and informative.
Multiple studies have shown associations between preexisting cardiovascular disease and more severe COVID-19. In addition, the pandemic’s effects reach far beyond those who contract the virus changing patterns of diet and exercise, and impacting mental health. There are lingering questions about the long-term cardiopulmonary effects of COVID-19 that will need to be answered.
Recently, important initiatives to collect robust COVID-19 data on cardiovascular patients have been formed. For example, American Heart Association Get With the Guidelines registry is systematically collecting data on patients hospitalized with COVID-19, of which many have high risk cardiovascular disease. NCDR Chest Pain-MI and CathPCI registries will also capture COVID-19 related elements. Similar collection efforts are desperately needed across ongoing cardiovascular clinical trials, which enroll high-risk patients by design. Systematic data collection on COVID-19-like illness in these populations will have implications for trial analysis and interpretation, long-term monitoring, and regulatory considerations.
During the early part of the pandemic, the Heart Failure Collaboratory (HFC), a unique organization fostering academic-industry-FDA partnership, sought to answer this call by creating a tool to effectively capture COVID-19 data across ongoing, planned, and recently completed cardiovascular clinical trials. The multi-stakeholder organization has created a data collection form (HFC COVID-19 CRF) designed to be paired with existing trial data collection. Pertinent elements include COVID-19-like symptom assessment, testing, and medication changes. In addition, the tool collects information on the effects of the pandemic on trial participants regardless of COVID-19 status, including incident use of telemedicine services, deferred/delayed cardiovascular care, and changes in social behavior. In many instances, the HFC COVID-19 CRF could be sent directly to patients, offloading burden on clinical sites and directly engaging clinical trial participants in ways that could be useful for the design of future trials.
HFC is partnering with trial sponsors to help better understand the burden of COVID-19 in their individual trial populations. In addition, pooling of de-identified data across trials will provide insight into the effects of the pandemic across the broader cardiovascular community. Where possible, serological information will be included to understand the true burden of disease and potential legacy effects on health among those exposed and recovered. The HFC COVID-19 CRF is designed to extend well beyond heart failure, and has received interest from other cardiovascular domains, including trials sponsored by the National Institutes of Health.
Data collection efforts such as the one championed by the HFC epitomize the very notion of academic-industry-regulatory partnership. In a world siloed by physical distancing, we are stronger, better informed, and more well guided when we work together.
Ankeet Bhatt is a Cardiology Fellow at Brigham and Women’s Hospital