Study finds big gaps in clinical trial process

A new report out says that the clinical trial process routinely ignores women, the elderly, minorities, the disabled and people living in rural America. And the practice of ignoring large groups is creating a trial process that often avoids the very patients the drugs are intended to serve, according to the Chronic Disease Prevention & Control Research Center at Baylor College of Medicine. The elderly, for example, are often excluded from trials that test new drugs for Alzheimer's, Parkinson's and other conditions that primarily afflict older people. Excluding minorities, meanwhile, skews the data in such a way that trials fail to discover how genetics and cultural factors [1] can affect outcomes.

"We've got a big problem," said Daniel S. Goldberg, chief policy adviser for the report. "And it's extremely urgent that we fix it. Because we're trying to figure out how to streamline healthcare and make people healthy, of course. And the fact that we have under-representation in clinical trials undermines both of these goals and undermines the quality of the evidence we come up with."

Altogether there are some 80,000 clinical trials mounted every year in the U.S. Many are duplications of other trials that have already been completed or are underway. And less than one percent of the population is recruited to participate.

- read the article [2] in the Washington Post

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Researchers fight for ethnic diversity in trials. Report [1]
Report: FDA lax in clinical trial oversight. Report [3]
Safety oversight a rare feature in child drug trials. Report [4]
Duke, FDA join forces to overhaul clinical trials. Report [5]