How COVID-19 Is Impacting Ongoing Clinical Trials

By now, it is abundantly clear coronavirus disease 2019 (COVID-19) has impacted the day-to-day lives of citizens from virtually every corner of the world, but many clinicians and researchers are beginning to worry about the long-term impact of the outbreak.

While many have used this as an opportunity to apply things we have learned during the outbreak, including the usability and effectiveness of telehealth, some are more concerned with the negative implications of COVID-19.

In addition to the impact on mental health and burnout in medicine, the COVID-19 pandemic has also left some concerned over the state of ongoing clinical trials. With years and sometimes decades of research and work going into many pivotal trials, the wide-reaching impact of the disease has raised a plethora of questions of how it may alter the procedures or outcomes of the research.

While major regulatory commissions such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have been commended for their communication and recommendations for organizations during this time, with COVID-19’s severity an issue for many requiring treatment for cardiovascular conditions or forms of cancer the heightened level of concern remains.

During a recent interview discussing GALACTIC-HF, an international phase 3 trial examining the use of omecamtiv mecarbil, HCPLive® asked John Teerlink, MD, professor of medicine at University of California San Francisco and Executive Committee Chair of GALACTIC-HF, about the impact of the outbreak on ongoing trials.