"The individual comments you'll hear are truly reflective of the group's thinking, " said Patrick O'Gara, vice chairman of clinical affairs at Boston's Brigham and Women's Hospital.

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In the studies, Cholestin had no side effects, except for a few cases of flatulence, according to Joseph Chang, vice president of clinical affairs at Pharmanex.

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"It's used particularly for open-heart surgery, where you need immediate control of the anti-coagulant, " says Jack Ansell, vice chair of clinical affairs at Boston University Medical Center.

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If outside investigators want additional information, "we would have to discuss it internally, " says Howard Mayer, head of global clinical development and regulatory affairs at Shire.

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Over the past two decades, Dr. Moscicki has been responsible for worldwide global regulatory and pharmacovigilance matters, as well as all aspects of clinical research and medical affairs for the company.

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This meant building a team of anywhere from ten to fifty people to deal with all the complexities of the process: chemistry, biology, regulatory affairs, clinical medicine, finance, business development, patent strategy, etc.

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"It has been a high-growth area, a high-demand area, particularly in the U.S. and to some extent globally, " says John Lewis, vice president of public affairs for the Association of Clinical Research Organizations.

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The Office of Veterans Affairs, along with several pharmaceutical companies, paid for the clinical trial.

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The Health Affairs study's conclusions are "largely around billing practices, not around clinical practices, " said George Kwass, a pathologist based in Massachusetts and board member of the College of American Pathologists.

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