Company Seeks To Increase Minority Representation In Clinical Drug Trials

Main Category: Clinical Trials / Drug Trials
Also Included In: Public Health
Article Date: 09 Nov 2007 - 7:00 PDT

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Ensuring that clinical research studies include a diverse population of participants is "important because type 2 diabetes and a host of other diseases affect ethnic minority groups differently," the Indianapolis Star reports.

According to the Star, FDA has been urging pharmaceutical companies to more closely examine how their drugs work in minority populations. An agency study showed that from 1995 to 1999 minorities were seriously underrepresented in 2,581 registered clinical trials for 185 drugs. Minorities often represent fewer than 15% of patients in clinical drug trials.

Without information on how the drugs affect minorities, products can reach the market 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 have a minority partner in a clinical trial, there might be a possibility that a drug might not be as effective (for a) certain race or ethnic group," Jewell added.

Indianapolis-based company Anaclim, founded by two Eli Lilly executives in 2005, helps companies recruit minority participants for drug trials, as well as minority physicians to run the tests. Currently, Anaclim is working on nine clinical trials that are studying diabetes and cardiovascular disease. It also has worked for small biotechnology companies, Rex Alexander, Anaclim's vice president of clinical operations and co-founder, said.

Alfonso Alanis, CEO and co-founder of the company, said, "Minority investigators have been ignored in the clinical research business," adding, "They're going to be major consumers of resources. It makes no sense to develop a drug in a population of patients that's not going to use the drug." Alexander and Alanis plan to expand their company to areas outside the U.S., such as Central America, Europe and India, in an effort to "open doors to even more diverse populations," according to the Star (Bowen, Indianapolis Star, 11/6).

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