Human testing can be rigorous - East Valley Tribune: Chandler

Human testing can be rigorous

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Posted: Sunday, November 19, 2006 6:23 am | Updated: 4:25 pm, Fri Oct 7, 2011.

Across the parking lot from Covance’s main laboratory facility in Madison, Wis., sits the company’s new Clinical Research Unit. It’s where humans become the guinea pigs near the end of the federal drug-approval process.

Data collected here eventually turns into dosage amounts and warning labels for drugs about to go on the market.

Covance offi cials have not yet decided whether such a clinic will be part of their initial plans in Chandler, but it’s defi nitely a possibility, they said.

The Madison clinic has 72 beds where volunteers, generally healthy adults ages 18 to 35, agree to give up their favorite snacks, time with friends and loved ones, and even control over when they use the bathroom, for $175 to $250 a day.

“We like to tell them we pretty much control your life at this point,” said Mary Westrick, a global vice president and general manager who runs the Madison clinic.

Volunteers are recruited from around Madison and typically stay a few days. Upon arrival, clinic staff members search volunteers’ luggage for contraband — basically chocolate and Tic Tacs, Westrick said. They’re not allowed visitors and can’t leave without dropping out of the study.

“Frankly, we’re not worried about volunteers leaving,” Westrick said. “We’re more worried about someone sneaking in their girlfriend in the middle of the night.”

Bathrooms are locked. Regular urine samples are part of the deal and the staff doesn’t pass up any opportunities.

Federal regulations forbid paying according to the potential risks of the particular drug being tested. Instead, Covance pays its volunteers according to the amount of discomfort they can expect. “We did have a study where people had three colonoscopies,” Westrick said. “They were paid really well.”

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