Drs. Kalil, Gomez co-author guest editorial in JAMA

In a guest editorial for the prestigious Journal of the American Medical Association (JAMA), UNMC’s Andre Kalil, MD, and Carlos Gomez, MD, validate the importance of clinical trials in a pandemic.

Dr. Kalil, professor in the UNMC Division of Infectious Diseases in the Department of Internal Medicine, has been at the forefront of clinical research related to COVID-19 since the start of the pandemic.

He helped make UNMC an active participant in the National Institutes of Health’s Adaptive COVID-19 Treatment Trial (ACTT) network, formed in February 2020.

Drs. Kalil and Gomez, an associate professor of infectious diseases, joined with co-author Angela Huttner, MD, of the Division of Infectious Diseases at the Geneva University Hospitals and Faculty of Medicine in Geneva, Switzerland. Their editorial, which was published earlier this month, is titled, “Translating Clinical Trial Results to Clinical Practice During a Pandemic.”

The authors were invited to weigh in on a related publication of results from an international clinical study into whether therapeutics abatacept, cenicriviroc or infliximab provided benefit when added to standard care for COVID-19 pneumonia.

The authors called the study a well-executed, well-resourced trial that enhances the evidence around COVID-19 therapeutics but also highlights interpretations and potential misinterpretations of scientific findings.

“The challenges of translating trial outcomes to clinical practice during pandemics,” the editorial authors wrote, “requires novel approaches and fresh solutions to improve the care of patients hospitalized for COVID-19, decrease treatment inequities and ultimately optimize public health worldwide.”

The editorial notes that the clinical study did not detect benefits in time to recovery as its primary outcome, but as a secondary outcome did detect a reduction in mortality at 28 days.

The authors wrote that a study can be swiftly translatable to clinical care when both primary and secondary outcomes are met. But when the outcomes are discordant, as in this just published trial for the COVID therapeutics, a different interpretation is needed, the authors wrote. If the primary outcome appears to be negative, they said, it should be thoroughly investigated as to why it did not work.

The authors wrote: “Even as the pandemic enters a new phase, the results reported from these adaptive trials have important ramifications for current and future investigations of novel therapeutics during a pandemic.”

Dr. Kalil said clinical trials are essential to discover new medical treatments, providing central information regarding the safety and efficacy of a new treatment.

“The appropriate interpretation of a randomized controlled trial is important to successfully apply its new findings to clinical care,” he said, “so each patient can have the opportunity to receive a more personalized line of treatment.”