Report Claims Clinical Trials Miss Many Populations

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However, it is the continuing absence of specific constituencies in many trial populations that gets the lion's share of the criticism.

The research looked at cancer clinical trials and found that only 25 percent of patients in such trials were over the age of 65. In addition, older people were often excluded from studies focused on Alzheimer's, arthritis and incontinence, the researchers noted.

As evidence of the problem, Weinberg and his colleagues honed in on a study of clinical trial composition that found that, between 1995 and 1999, blacks, Asian-Pacific Islanders, Hispanics and Native Americans together made up for less than 10 percent of patients included in new cancer drug trials.

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Under-representation of this sort, they say, leads to results that do not account for a host of factors -- genetic, cultural, racial, religious, linguistic, as well as variables related to age and gender -- that could have a huge impact on how well new drugs do in the real world.

To address these shortcomings, the team proposed nine policy solutions:

• government regulatory changes;
• increased collaboration between government and private industry on clinical trial design;
• increased community involvement in patient participation;
• scientific journal oversight of patient breakdowns;
• new, specialized training for review boards;
• reallocation of research funding to avoid duplication and address disparities;
• increased public education;
• increased focus on easing the patient participation process;
• guaranteeing insurance coverage for all related costs.

"The bottom line is there has been a lot of discussion and attention paid in recent years to how clinical trials are put together, and, in particular, the need to account for differences in study patient populations," said Weinberg. "And that's the good news. But the bad news is that as a practical matter, it has yet to have a real impact on studies themselves."

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