Submitted by Armen Hareyan on Nov 9th, 2007
Ensuring that clinical research studies include a diverse population ofparticipants is "important because type 2 diabetes and a host of otherdiseases affect ethnic minority groups differently," the Indianapolis Star reports.
According to the Star, FDAhas been urging pharmaceutical companies to more closely examine howtheir drugs work in minority populations. An agency study showed thatfrom 1995 to 1999 minorities were seriously underrepresented in 2,581registered clinical trials for 185 drugs. Minorities often representfewer than 15% of patients in clinical drug trials.
Withoutinformation on how the drugs affect minorities, products can reach themarket based on flawed data, Nancy Jewell, president and CEO of the Indiana Minority Health Coalition,said. "It's a major issue in the minority community. If you don't havea minority partner in a clinical trial, there might be a possibilitythat a drug might not be as effective (for a) certain race or ethnicgroup," Jewell added.
Indianapolis-based company Anaclim, founded by two Eli Lillyexecutives in 2005, helps companies recruit minority participants fordrug trials, as well as minority physicians to run the tests.Currently, Anaclim is working on nine clinical trials that are studyingdiabetes and cardiovascular disease. It also has worked for smallbiotechnology companies, Rex Alexander, Anaclim's vice president ofclinical operations and co-founder, said.
Alfonso Alanis, CEOand co-founder of the company, said, "Minority investigators have beenignored in the clinical research business," adding, "They're going tobe major consumers of resources. It makes no sense to develop a drug ina population of patients that's not going to use the drug." Alexanderand Alanis plan to expand their company to areas outside the U.S., suchas Central America, Europe and India, in an effort to "open doors toeven more diverse populations," according to the Star (Bowen, Indianapolis Star, 11/6).
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