June 25, 2017

Meet Worcester’s clinical trial pioneers

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Art Simas / For Worcester Sun

Dr. Charles Birbara and Mary Coughlin

Clinical pharmacology. Clinical trials. These phrases may not roll off the tongue with ease. And they probably do not convey a warm and fuzzy feeling … think of cold, hard surfaces, procedures, and questions, questions, questions.

Let’s debunk these perceptions right now. Everyone here wants you to get better. And they do not stop looking for answers to your situation.

From its beginning as Clinical Pharmacology Group in 1989 inside the former City Hospital on Queen Street, to its present quarters at 25 Oak Ave., Advanced Clinical Care has been headed by Director Mary Coughlin, R.N., and medical director Dr. Charles A. Birbara.

Coughlin has been involved in more than 500 clinical trials. She and Dr. Birbara have been at the forefront of transforming painful, debilitating diseases into pain-free or almost pain-free lives for their patients.

“My initial role (in the business) was to replace a coordinator who had left,” Coughlin said. “At that time (1975), there was only one study for osteoarthritis with about six patients enrolled. It was really just a part-time job.

“In the beginning, in my spare time, I would call the various drug companies, asking for the rheumatology departments, and try to talk to someone about what trials were going on. We got involved in some trials that way,” she said. “Then, if we did well with enrollment and with the data collection, we would get several more trials with that company.”

In the 1980s and early 1990s, drug companies wanted to control their own trials with their own personnel. But as time went on, the companies drifted from this insular approach.

“Soon there were more CROs (clinical research organizations) that were hired by the drug companies to run the studies. The CROs would find the trial sites and do all the training and monitoring for the pharmaceutical company,” Coughlin said. “A large CRO would have hundreds of studies in all different fields of medicine. If we did well in a study, the CRO might have a trial for another indication (symptom), and ask us to participate.”

Far from their lean, uncertain early days, Coughlin and Dr. Birbara have been among the vanguard in their field, developing a specialty in rheumatology and helping to bring pain-relieving drugs like Humira and Xeljanz to sufferers of arthritis, Crohn’s disease and other disorders.

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