Report Claims Clinical Trials Miss Many Populations

TUESDAY, April 1 (HealthDay News) -- A new analysis of the American clinical trial process suggests that the system for testing new drugs has routinely excluded or under-represented women, older people, minorities, disabled individuals and rural populations for decades.

"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 health care 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."

The report was conducted by the Chronic Disease Prevention & Control Research Center at Baylor College of Medicine in conjunction with the Intercultural Cancer Council, both based in Houston.

Part of a team of more than 300 analysts led by Armin D. Weinberg, Goldberg and his colleagues spent four years conducting an in-depth review of policy positions held by public, private and nonprofit clinical trial sponsors in the United States. Their research was funded by what is described as an "unrestricted educational grant" provided by Genentech Inc.

The team noted that about 80,000 clinical trials are conducted in this country each year, and that less than 1 percent of the American population -- 2.3 million men and women -- participate in such trials.

Additional trial problems, such as the lack of adequate training for members of institutional review boards, who are legally obligated to assess the structure of a proposed trial, were cited.

The report also admonished against the wasting of limited resources that results when government institutions and private industry duplicate each other's efforts in conducting trials focused on the same disease or treatment.

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.

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: