Anaclim Established to Address Minority Clinical Trial Participation

Anaclim, an Indianapolis, Ind.-based contract research organization (CRO) established specifically to address issues involving minority participation in clinical trials, has launched.

The company was co-founded by Alfonso Alanis, M.D., now Anaclim’s chairman and chief executive officer. Alanis is a loaned executive from Eli Lilly and Company and the majority founding partner of Anaclim. The company has 12 employees and is also certified as a minority owned business.

“During my seven year tenure as the chief medical officer at Eli Lilly, I became keenly aware that minority recruitment was a big issue within the pharmaceutical industry. No one seems to be able to bring enough minority patients into clinical trials. I quickly figured out that this was an area, a niche, which was very important to fill, and at the same time constituted a very good business opportunity,” Alanis told CWWeekly.

The new company will not only address issues surrounding minority patient enrollment, but the lack of minority investigator participation as well. A study published by the National Institute of Health (NIH) suggests that ethnic minority patients tend to seek out minority physicians whom they feel more comfortable with or who may speak their language. “It is not only ethnic minority patients that are unrepresented in trials, minority investigators are woefully unrepresented also. So our strategy works because we have access to a significant number of minority physicians, who have minority patients as the base of their patient populations,” said Alanis.

Anaclim has a database of 1,300 minority physicians in a number of specialties. About 75% of the investigators have performed clinical trials in the past.

It was widely believed that racial and ethnic minorities are less willing to participate in health research. However, a new study published in December 2005 in the journal PLoS Medicine, a publication of the Public Library of Science, suggests otherwise. The study found that racial and ethnic minorities in the U.S., particularly African-Americans and Hispanics, are as willing to participate, and in some instances more willing to participate in research than whites, when invited to participate.

According to Alanis, Eli Lilly’s chairman and chief executive officer Sidney Taurel has been instrumental in supporting the business and its cause. “People don’t realize how committed Sidney Taurel is to this issue. He is very serious about the whole area of minority recruitment and diversity,” Alanis told CWWeekly. In fact, Anaclim’s senior management comprises many industry veterans who have worked at Eli Lilly in the past. Rex Alexander, Anaclim’s vice president of clinical operations and a founding partner, retired from Lilly after 33 years, where he held multiple clinical trials management positions. Robert Scott, M.D., now chief medical officer at Anaclim, worked for Lilly for 13 years in several management positions. Anaclim’s third founding partner and chief operating officer is Jon King, who joined the company after starting his own healthcare focused management consulting firm.

Management at Anaclim hopes to develop the company into a full service CRO, while only outsourcing some specific components of the trial process. “We will do project management, monitoring and data management, but right now we aren’t interested in phase I or statistical analysis and final report writing. But if a company comes to us and says they want us to run their entire project, we can do that.We have partnerships and alliances with companies that do these types of services,” said Alanis.

Anaclim has been in discussions with major pharmaceutical companies such as Amgen, Novartis, Bristol Myers Squibb, and Johnson & Johnson. “Everybody recognizes this is a big issue.We haven’t signed any contracts formally, but we have recently been selected by Lilly to run a diabetes trial in Q1 2006,” said Alanis.