Mayo Clinic Researchers Caution Against ‘Exaggerated’ Early Trial Results

Fares Alahdab, MD, Assistant Professor of Medicine at Mayo Clinic

Fares Alahdab, MD, Assistant Professor of Medicine at Mayo Clinic

In Greek mythology, Proteus has been called the god of “elusive sea change,” which suggests the constantly changing nature of the sea or the liquid quality of water in general.

In clinical trials, the Proteus effect is a name given to a phenomenon of early exaggeration followed by moderation over time.

A new study by researchers from the Mayo Clinic suggests Proteus is more than a Greek myth. The study reports that positive early results from clinical trials are often exaggerated.

Nearly 40% of studies reviewed by the research team contained hyped results, says Fares Alahdab, MD, an assistant professor of medicine and lead author of the study. He’s also a research fellow in the Mayo’s Clinic’s Evidence-Based Practice Research Program. “Physicians and patients should be cautious about new or early clinical trial evidence,” he warns. “Exaggerated results could lead to false hope as well as possibly harmful effects.”

The study reviewed thousands of research articles from general medical journals using impact factors, an internationally recognized ranking system for scientific journals. The team collected 70 meta-analysis articles published between January 2007 and June 2015. The articles included results from 930 clinical trials.

The study found an initial effect that was 2.67 times larger than what was eventually shown when subsequent trials were published. “Often, patients are living with more than one chronic condition, and they and their doctors watch for research about new treatments,” says M. Hassan Murad, MD, MPH, director of Mayo’s Evidence-Based Practice Research Program and a contributor to the study. “They need to be aware that the effect seen in earlier trials may not bear out over time and may be much more modest.”

With a nod toward Proteus, the Mayo team hopes its study will encourage clinical research colleagues to temper their language to avoid providing false optimism.

Author: Michael Causey