The emergence of COVID-19 has forced clinical researchers to endure major setbacks related to existing academic and industry-sponsored clinical trials. Recognizing these constraints, the ACC convened a focused Heart House Roundtable on May 29 to better understand the pandemic’s implications for ongoing and future cardiovascular research.

"Because of the global COVID-19 pandemic, we are facing unprecedented times in clinical research,” said James L. Januzzi, Jr., MD, FACC, who co-chaired the Roundtable along with Harlan M. Krumholz, MD, SM, FACC. “Unforeseen obstacles are now present in all types of clinical investigation, from observational research to clinical trials. This meeting reflects the ACC’s commitment to facilitating generation of actionable knowledge to improve heart health even in these challenging times."

Patient enrollment, regulatory constraints and interpretation of outcomes data, are just a few of the challenges posed by COVID-19 on the research community – challenges that are not likely to go away soon. In a newly published piece in the Journal of the American College of Cardiology, Emilia Bagiella, PhD; Deepak L. Bhatt, MD, MPH, FACC; and Mario F. L. Gaudino, MD, PhD, FACC, note the consequences of the COVID-19 “disruption of trial activity are unprecedented and likely to affect the evidence generated in the next few to several years.”

Javed Butler, MD, MPH, MBA, FACC, speaking at the Roundtable, highlighted the vastness of the entire spectrum of clinical research from people and processes to phases and types, as well as the many goals and objectives tied to each clinical trial from patient safety to trial integrity – not to mention the incorporation of COVID-19 data as well.

“There isn’t a one-size-fits-all solution,” said Bray Patrick-Lake, MFS. “There needs to be a lot of openness to trying new things going forward.”

According to Ty J. Gluckman, MD, FACC, one solution might lie with virtual care now that telemedicine has rapidly emerged as a key component of safely continuing to provide care for patients. Other Roundtable participants agreed, noting remote data capture and remote consent, as well as the ability to remotely monitor patient populations that might be less able to participate in traditional clinical trials, all have potential.

“The environment we’re in right now is making us think differently,” said Monica Shah, MD, MS, MHS, FACC, “and some of the things we’re doing actually work.”

Roundtable participants also emphasized the need to look at entire trial designs. “Every part of the protocol needs to be scrutinized in a prospective way,” said Bram Zuckerman, MD, FACC, who stressed the importance of looking carefully at statistical analysis plans and stratification analyses, especially in terms of COVID-19 data.

Jagat Narula, MD, PhD, MACC, echoed these sentiments. “As we look at the data that comes in … we need to look at the quality of the study. We need to open our minds beyond the timeline and get in to how well the study was done,” he said. Narula also suggested that journals like JACC provide practical guidance to authors.

These recommendations are timely given the retractions published in both The New England Journal of Medicine and The Lancet regarding data used in two studies of drug therapy and COVID-19.

Looking to the future, Krumholz and Januzzi said the goal coming out of the Roundtable is to really address the uncertainty and provide guidance on what this means for research, for the patients, for the organization and for training.

“Coming out of today’s roundtable, I hope we can prioritize next steps around what guidance is needed to support the cardiovascular community as clinicians navigate how to conduct research during the pandemic and identify key clinical questions to support future observational and experimental clinical trials designs post the COVID-19 pandemic,” said ACC President Athena Poppas, MD, FACC.

The Heart House Roundtable is part of a larger, comprehensive COVID-19 science and education effort by the College. Future Roundtables in this series will address topics like telehealth, which is quickly emerging on the scene but additional guidance is needed. In addition, the ACC’s Summer COVID-19 Education Series is designed to provide free, virtual education and discussion on critical topics for cardiovascular professionals around the world who are on the COVID-19 front lines.

Focused Heart House Patient Forums, the first of which was held May 28, are also important elements of the College’s effort. The goal: to ensure patient needs and concerns inform any future guidance and action. According to Erica Spatz, MD, MPH, FACC, one of the things heard a lot in the first Patient Forum was concern about the trade-offs people have to make when it comes to managing their cardiovascular disease and symptoms and the very real fears of COVID-19 risk. “There are no easy answers and there’s no right way – every case is different,” she said. “It’s important to recognize these are difficult times and have compassion for one another since everyone is trying to do their best.”

Clinical Topics: COVID-19 Hub

Keywords: Coronavirus, COVID-19, severe acute respiratory syndrome coronavirus 2, Telemedicine

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