How Are Regulatory Agencies Supporting Research During COVID-19?

The COVID-19 pandemic may disrupt cardiovascular drug and device deployment, according to a report published Nov. 16 in the Journal of the American College of Cardiology. The report discusses the central role of regulatory authorities in supporting research adaptations to the realities of the pandemic.

Muthiah Vaduganathan, MD, MPH, and participants from ACC's "Cardiovascular Clinical Research in the COVID-19 Era Roundtable," which convened clinical trialists, public and private sponsors, payers and patients virtually in May 2020, sought to examine how the COVID-19 pandemic has affected regulatory strategy and the pipeline of cardiovascular drugs and devices.

The report shows that since the beginning of 2020, the U.S. Food and Drug Administration (FDA) has approved or tentatively approved nearly 500 cardiovascular therapies. The authors point out that "[the] pace of these approvals have been relatively steady even during the initial phases of COVID-19." However, a lot of the work for those approvals was already advanced when the COVID-19 pandemic hit. "New applications are anticipated to be slow, resulting in a potential reduction in future cardiovascular therapeutics in the pipeline," write the authors.

The report examines how the FDA is ensuring access to existing therapies, regulatory flexibility in supporting a sustainable therapeutic pipeline, and other regulatory considerations including, informed consent, data collection, endpoint ascertainment and more.

"Clinical trialists and sponsors should actively work with regulatory authorities to mitigate the impact of COVID-19 on the current and future development of cardiovascular therapies," write the authors. "Development of innovative strategies to conduct trials and interpret affected data during this pandemic may yield lasting improvements to the cardiovascular clinical trial enterprise."

Keywords: COVID-19, Pandemics, Cardiovascular Agents, United States Food and Drug Administration, severe acute respiratory syndrome coronavirus 2, Writing, Data Collection, Cardiology, Informed Consent


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