Report Claims Clinical Trials Miss Many Populations

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."

"And the problem is that many people, when they take a pill, don't realize that it didn't come out of thin air," added Weinberg. "So, we hope that our work will help people appreciate how the process works, and that what we're talking about is the next generation and how we improve the products and type of therapies that we will have in the future."

Adil Shamoo, a professor of biochemistry and bioethics at the University of Maryland School of Medicine in Baltimore, agreed that trials must ensure proper patient representation. And he stressed that the problem stems from a lack of structural focus, rather than from any lack of potential volunteers.

"We have an extremely willing volunteer population in this country, so there is no question that proper trial representation is doable," said Shamoo, who is also the co-founder of the nonprofit Citizens for Responsible Care and Research, based in Columbia, Md. "And medicine is going to be given to millions of different people, so you do need that representation. Otherwise, you can have risks that you won't know about."

Other reports released this week buttress the findings of the Baylor team.

On Monday, Duke University researchers reported at the American College of Cardiology meeting in Chicago that although more women are being included in clinical cardiology trials, their numbers are still so low that it's questionable whether the results can actually be applied to women. And a commentary in the April issue ofThe Lancet Oncologystressed that more teens and young adults need to be included in trials of new cancer drugs, because they are currently under-represented.

More information

For additional information on clinical trials, visit the U.S. National Institutes of Health.

SOURCES: Daniel S. Goldberg, chief policy adviser, Intercultural Cancer Council, and doctoral student, ethics and medical humanities, University of Texas Medical Branch, Galveston, Texas; Armin D. Weinberg, Ph.D., director, Chronic Disease Prevention & Control Research Center, Baylor College of Medicine, Houston; Adil Shamoo, Ph.D., professor, biochemistry and bioethics, University of Maryland, School of Medicine, Baltimore, and co-founder, Citizens for Responsible Care and Research, Columbia, Md.