Mayo Clinic: 1 in 3 Early Clinical Trials on New Drugs and Medical Devices Exaggerate the Treatment's Effect on Patients

By Perry, Susan | MinnPost.com, February 26, 2018 | Go to article overview

Mayo Clinic: 1 in 3 Early Clinical Trials on New Drugs and Medical Devices Exaggerate the Treatment's Effect on Patients


Perry, Susan, MinnPost.com


Early clinical trial results regarding new drugs and devices for the treatment of chronic medical conditions often turn out to be exaggerated, reports a new study by researchers at the Mayo Clinic in Rochester.

Indeed, more than a third of early clinical trials for drugs and devices in the study showed positive results that turned out to be substantially inflated when compared with the results from subsequent trials.

“Physicians and patients should be cautious about new or early clinical trial evidence,” said Dr. Fares Alahdab, one of the study’s authors and an evidence-based medicine researcher at the Mayo Foundation for Medical Education and Research, in a released statement. “Exaggerated results could lead to false hope as well as possibly harmful effects.”

The so-called Proteus phenomenon — the tendency of the positive findings of early clinical trials to be contradicted by later ones (named after the Greek sea-god who could quickly alter his appearance) — has been observed before, but primarily in the context of specific types of diseases, such as endocrine disorders. The Mayo Clinic researchers wanted to examine the phenomenon across a wide range of chronic illnesses.

Looking at the issue more broadly is important, given the large number of people currently living with one or more chronic medical conditions, such as heart disease, stroke, cancer, diabetes, kidney disease and chronic obstructive lung disease (COPD). Treatments for these conditions can save and extend lives, but they can also have significant side effects. Having accurate information to weigh the benefits and harms of new treatments is therefore essential.

Study details

For the study, Alahdab and his colleagues reviewed almost 2,700 randomized controlled clinical trials (considered the gold standard of research) that had evaluated a drug or device in patients with a chronic disease. All the studies had been published between January 2007 and June 2015 in one of the top 10 high-impact medical journals.

From that larger pool of studies, the Mayo researchers focused on 70 meta-analyses, which included the results of 930 clinical trials involving about 66,000 participants. …

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