State touted as test site for new drugs > Hospitals hope to draw more clinical research

LEWISTON — Three Maine hospitals are combining resources and asking others to join their effort to get drug manufacturers to consider using the state for clinical trials of new drugs.

Central Maine Medical Center in Lewiston, Mid-Maine Medical Center in Waterville and Kennebec Valley Medical Center in Augusta have formed Northern New England Clinical Trials Inc. to carry out the effort.

Three other hospitals in the region — Maine Medical Center in Portland, Eastern Maine Medical Center in Bangor and Dartmouth-Hitchcock Medical Center in Hanover, N.H. — have been invited to participate.

If successful, the venture could benefit the state’s hospitals, physicians and patients, who would gain access to new therapies before they become available to the public.

John W. Norton of Bridgton, president of Northern New England Clinical Trials, said Maine’s geography and demographics could be attractive to companies seeking to test new drugs.

“Maine has something like the third- or fourth-oldest population in the nation,” he said. “Our elderly population is useful because there’s a lot of drug development and tailoring done for the geriatric population.”

Another plus for Maine, according to Norton, is a less-transient population that tends to stay longer in one location.

When organizing drug trials that can go on for a year or more, pharmaceutical manufacturers seek a population from which they are less likely to lose patients whose results they plan to monitor in follow-ups, he said.

Proximity to Boston, home of Massachusetts General Hospital and other institutions known for their eminent researchers and clinicians, also raises the likelihood that Maine would be chosen as a test site, Norton said.

“They want a well-respected name heading up their studies and that person would still come from Boston,” he said. While it is “not unthinkable” that an entire study could be done in Maine, it would be more likely that the state would be selected as a “satellite center.”

“What Maine’s geography has, quite frankly, is that we’re pretty close to Boston,” he said.

Norton emphasized the need for meticulous record-keeping by those involved in the studies, which are carefully scrutinized by the Food and Drug Administration.

“(The companies) want a place where all the FDA requirements are met. The FDA will look at every record,” he said.

While the trials would bring financial gains to hospitals and doctors, patients whose conditions show no signs of improvement could also benefit.

“Almost always, there are patients who are not doing well on their existing therapies,” Norton said. They would be recruited by doctors and would have to give informed consent before they could participate in the trials.

The project also would help keep Maine physicians abreast of the latest therapies and techniques, Norton said.

“It’s the best possible continuing education,” he said. “It’s a great way for them to keep up.”

The trials are conducted in hospitals and doctors’ offices, Norton said, and patients are more closely monitored than under normal conditions. The costs are reimbursed by the drug companies, which can spend $100 million in developing a new drug, a process which can take a decade or more.

Norton has organized a conference Saturday at Central Maine Medical Center to explore the prospects of bringing more clinical research to the state.

The conference will examine the drug discovery and drug registration processes, the design of clinical trials and the role played by physicians and hospitals. Representatives from the FDA and the pharmaceutical industry will attend.

Invitations have been sent to more than 1,300 physicians and to hospitals throughout the state, Norton said.