Sunday, April 06, 2008

Clinical Trials Miss Many Populations

A new report by the Chronic Disease Prevention & Control Research Center at Baylor College of Medicine, in conjunction with the Intercultural Cancer Council, brings the grim but not unexpected news that clinical trials for testing new drugs has routinely excluded or under-represented a broad category of people, including women, minorities, the disabled, elderly, and those who don't live near major research hospitals/urban areas. (And in fact, this very subject is one of the first conversations I remember having with Kathryn Hinsch - the fact that even animal research is done on male models.)

According to the report, there are about 80,000 clinical trials run in this country every year, and only about 1% of the population participates in them (working out to around 2.3 million people). The report didn't limit its critique to the statistical information of those participating in the trial, but also criticised wasted resources and duplicate efforts between government and private funding and the lack of training of IRB members. But the major focus of the report was on the constituencies of trial populations:
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... As evidence of the problem, [the researchers] 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.
The researchers also acknowledge that while there has been a lot of discussion about clinical trial populations and their make-up in recent years, very little has been done to redress the issue. To that end, the report actually also offers nine concrete policy suggestions to fix/improve clinical trials in the United States:
  • 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.

And on a personal note, we'd like to extend congratulations to friend of the blog (and fellow blogger) Daniel Goldberg, one of the researchers on this project and the leading quote in the Washington Post coverage of the story. Daniel's off enjoying the cherry blossoms in DC right now, but perhaps when he's back from his conference, he'll step over here and talk to us a little bit more about his research.
-Kelly Hills


SabrinaW said...

No surprise here. Ironically, there is some resistance to considering race-specific responses to drugs because there is an historic suspicion of drawing any physiological differences due to race.

As far as sex-specificity goes, my cynical side has to ask if it is better to get over-simplified data that will be applied to everyone, or to have to wait a little longer to do a more accurate study. "Because women are complicated" seems to be just as much a reason TO do such research as it is to not do it.

Anonymous said...

Thanks for the kind words -- I'd be happy to discuss. Maybe the most helpful format would be to have someone give me some questions they'd like answered (starting with Sabrina's excellent question above), and then perhaps the answers can be posted?

Suggest other formats, if you'd like . . .

Kelly Hills said...

That sounds good, Daniel. :-) Maybe next week we can sit down for a Q&A and then post the results.