Clinical trials put area doctor at vanguard of medicine

Board-certified psychiatrist retired early to start research center

DAYTON — Dr. Bernadette D’Souza likes working on the cutting edge of medicine.

After 22 years with the Cincinnati Veterans Affairs Medical Center, the board-certified psychiatrist took early retirement seven years ago to start her own business.

At the time, Cincinnati bustled with clinical trials, but D’Souza said there wasn’t nearly as much psychiatric clinical research under way in Dayton.

So D’Souza, formerly a colonel in the Air Force Reserve based at Wright-Patterson Air Force Base, moved north. In 2003, she started Midwest Clinical Research Center, which specializes in psychiatric research.

The clinical research center screens 250 people in person each year at its Elizabeth Place office in Dayton, about 70 percent of whom are found eligible to take part in clinical trials of medications for mental health disorders. The research patients, or subjects, are compensated for time and travel.

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D’Souza declined to disclose annual revenues, saying only that they exceed $1 million. She said the costs of running a clinical research center are considerable: staff, three examination rooms, centrifuges, echocardiogram machines, and training- and assessment-related costs.

Revenues were down more than 10 percent in 2009 from their 2007 peak, said Robert Magrino, the center’s operations director.

D’Souza primarily attributes the decline to a lack of referrals that satisfy increasingly stringent criteria for clinical trials. The enrollment rate for clinical trial participants declined from 75 percent in 1999 to 59 percent in 2005, according to the Pharmaceutical Research and Manufacturers of America’s 2010 profile of the industry.

PhRMA said its members spent more than $32.2 billion on clinical trials for drugs in 2008, the most recent year for which that data is available.

Strengthening the physician referral network will be key to growing the business, D’Souza said. In fact, she said, she plans to soon hire either a third psychiatrist for the center or an internist.

“I would love for physicians in the community to view this as another resource available to their patients,” she said. “Making this option available to their patients is part of providing good clinical care.”

The clinical research center typically has eight clinical trials under way at any one time. As the Food and Drug Administration weighs whether to approve flibanserin, a drug touted as a boost for depressed female sex drive, D’Souza’s research center is one of several test sites for a “similar” drug. It’s meant for women with both low sex drive and clinical depression. The research center has a contract to provide the drug to 12 subjects. Three have been approved for the trial so far.

The prospect of a drug that can restore lost sex drive in women coping with mental illness is significant, D’Souza said.

“A lot of women discontinue their medications because of decreased sexual function,” she said.

Midwest Clinical also has taken part in clinical trials for quetiapine (Seroquel) to see if the antipsychotic drug could be used to treat bipolar depression as well as schizophrenia, and for aripiprazole (Abilify) for treatment-resistant depression.

Midwest Clinical primarily takes part in Phase III trials, or trials that take place after preliminary evidence suggests drug effectiveness. Such trials are meant to gather more information to evaluate the drug’s benefit and risk relationship and provide a basis for physician labeling.

The research center takes part only in privately funded trials. In the United States, 25 Phase III, privately funded trials of depression drugs started in 2009, 30 in 2008 and 23 in 2007, according to clinicaltrials.gov.

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