University HealthCare Alliance

August 03, 2020

Many Early COVID-19 Studies have Low-Quality Design, Risk Low-Value Evidence, Research finds

The COVID-19 pandemic mobilized scientists around the world to start a flurry of clinical trials so they could better understand the new disease.

However, many studies initiated before mid-May failed to meet quality standards — particularly in size and reach — causing concerns that the evidence could be of little meaningful use in guiding the public response, scientists from Stanford Medicine and Yale wrote in a new research letter.

The trials conducted early on gave the medical community more knowledge about COVID-19, Mintu Turakhia, MD, an associate professor of cardiovascular medicine at Stanford, said in an interview. But larger patient studies with more controls will better inform protocols for treating the disease.

“These smaller trials aren’t going to give us the best evidence we need,” Turakhia, the senior author of the study published this week in JAMA Internal Medicine, said.

Unlikely to produce meaningful evidence

Turakhia and his colleagues looked at 1,551 COVID-19 studies listed in, a registry of U.S. and international clinical studies, as of May 19.

In research, best practices call for enrolling large numbers of patients at multiple centers who are randomly assigned to receive either a treatment or a placebo, with neither patients nor caregivers knowing which course the patient is taking.

But among the trials evaluated, fewer than half were randomized, fewer than a quarter took place at more than one center and only about a third included more than 100 patients. 

The researchers estimated that, based on trial design, only about 29% of the studies would produce data strong enough to potentially inform changes in clinical care.

“Even before results are known, most studies likely will not yield meaningful scientific evidence at a time when rapid generation of high-quality knowledge is critical,” they wrote in the letter.

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