Local

Study finds clinical trials routinely discriminate against disabled

BOSTON -- They are a critical part of the drug approval process -- but a new study finds clinical trials have a troubling tendency to exclude study subjects who are disabled.

The study, just published in the journal Health Affairs, analyzed nearly one hundred clinical trials registered on the federal website ClinicalTrials.gov. The analysis revealed only 18 percent of these trials had explicit accommodations just so disabled people could participate.

“We found an overwhelming majority of trials excluded one or more groups of people with disabilities,” said study co-author Barbara Bierer, MD, faculty director of the Multi-Regional Clinical Trials Center at Brigham and Women’s Hospital and a professor of medicine at Harvard Medical School.

Among the more common exclusions: psychiatric disorders, substance abuse, HIV, cognitive or intellectual deficiencies and issues with hearing, vision and mobility.

Bierer said their analysis covered clinical trials testing treatments for four diseases: depression, diabetes, lung cancer and dementia. The researchers found that, often, exclusionary criteria were unnecessarily broad -- such as disallowing all those with any neurological disorder from a study in which the new drug is known to trigger seizures, rather than just excluding those with a history of seizures.

“People write these quite generally without the specificity of either the reason -- here is why we’re excluding these people -- or saying what accommodations would be appropriate for this,” Bierer said.

In fact, Bierer said the inclusion of those with disabilities can enhance the quality of clinical trials  -- because more types of study subjects can mean more information about a drug’s effects before it hits the market.

“After it’s approved, it’s open to everyone in the market based on a physician’s prescription,” she said. “If you’ve never included the population in the trials you don’t know if it’s safe or effective. So now every single person becomes an experiment. We don’t know what we don’t know.”

Download the FREE Boston 25 News app for breaking news alerts.

Follow Boston 25 News on Facebook and Twitter. | Watch Boston 25 News NOW