Integrity of clinical trials should be ‘preserved’ in face of COVID-19

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Mary M. McDermott

Efforts and resources should be directed toward continuing randomized clinical trials in spite of the specter of the coronavirus pandemic. This is because of the potential of such studies to help millions of people suffering from debilitating chronic diseases, according to a new viewpoint published by the Journal of the American Medical Association (JAMA).

“Adapting protocols to facilitate continued intervention adherence, outcome measurement and some aspects of recruitment for trials already underway is likely to have the greatest benefit for the most people,” wrote Mary M. McDermott, MD, a professor of medicine and preventive medicine at Northwestern University in Chicago, and Anne B. Newman, MD, the department chair of epidemiology at the University of Pittsburgh Graduate School of Public Health, Pittsburgh. Maintaining such trials can be achieved “by using creative and thoughtful methods and proactive planning.”

The viewpoint, “Preserving clinical trial integrity during the coronavirus pandemic,” offered up a series of solutions and considerations to “minimize disruption and preserve integrity of ongoing randomized clinical trials, while ensuring participant health and safety.”

Among them: Collection of outcome must be given careful consideration, McDermott and Newman explain. “The primary outcome has highest priority, whereas outcomes that are exploratory or not pre-specified are more appropriate to eliminate temporarily.”

They also address the delivery of interventions, writing that those which can be adhered to safely, without the need for patients to leave their homes, should be continued. “In addition, when safe to do so, it may be appropriate to continue interventions, such as medications, beyond the originally intended stop date.”

Another consideration, they point out, is how interventions might interact with the coronavirus infection itself. This leads to the question of whether, for instance, a study on a drug should be continued if a participant becomes ill with symptoms of COVID-19.

“Conceivably, some interventions could improve outcomes,” McDermott and Newman note, explaining: “For example, a trial testing efficacy of a therapy such as a statin might mitigate the cardiovascular consequences of an acute inflammatory state. If continuing the intervention becomes untenable, intention-to-treat methods are essential for understanding risks and protective factors for infection, illness or recovery.”

McDermott and Newman finish by underlining the years of design and funding dedicated to clinical trials. They require years to conduct and complete, they write, “but are essential for improving health and preventing disability.”

The effects of the coronavirus on randomized trials, they conclude, “will hopefully will be short-lived, relative to the long-term benefits of these trials to millions of people who will continue to live with debilitating medical diseases after the crisis ends. To maximize public health benefits, creativity and persistence are required, especially during these unprecedented and uncertain times.”

SOURCE: DOI:10.1001/JAMA.2020.4689

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