Duluth medical trials need patientsWithout enough patients to test them, successful new medical treatments take longer to get approved and to market.
By: Candace Renalls, Duluth News Tribune
They’re cutting edge treatments.
A new type of cardiac stent. A drug found effective in fighting cancer. A medication effective at reducing the incidence of breast cancer for at-risk patients.
All have been among the standout successes of clinical trials done at Essentia Health. And there have been many — thousands since the trials began at Essentia in 1979. Through its Essentia Institute of Rural Health, clinical trials in the Duluth, Fargo and Brainerd areas have focused on new treatments for cancer, cardiovascular disease, neurological disorders, gastroenterology and more.
“They’re very important in the way they offer other opportunities for treatment for patients where maybe there was nothing else that could be given to them,” said Julia Pattison-
Crisostomo, the institute’s clinical research development manager.
Clinical trials of new drugs and medical devices are required to evaluate their safety and effectiveness before they can be federally approved for general use. It takes 10 to 15 years to develop a new treatment, with an average of seven years spent in clinical trials. The same trial can be conducted simultaneously at numerous institutes around the country, involving thousands of patients and under intense scrutiny by review boards.
Not all new treatments tested end up on the market, however. When it comes to experimental drugs, only one in five is ultimately approved, said Jeff Trewhitt, a spokesman for Pharmaceutical Research and Manufacturers of America, an industry group.
Essentia currently has nearly 170 trials under way with 1,000 participants,
“In Duluth, we have a very receptive community when it comes to research,” she said. “They’re fairly educated about it. At least we try to educate them. A lot of times, if they don’t participate, they live too far away or have too much going on”
But more participants are needed in Duluth — which ranks fourth in the number of clinical trials in Minnesota — as well as at other research facilities in Minnesota. Without enough patients, successful new treatments take longer to get approved and to market. So those in dire need of new treatments must wait longer.
In Duluth, 27 of more than 100 clinical trials at Essentia and St. Luke’s Hospital Whiteside Institute for Clinical Research need more participants, according to a report just released by Pharmaceutical Research and Manufacturers of America.
Pharmaceutical and medical device companies pay hospitals and research institutions to conduct the trials of their experimental drugs and devices, providing them with a source of revenue that results in jobs and helps local economics.
Last year, Essentia received $1.2 million from pharmaceutical and medical device companies to conduct clinical trials,
Pattison-Crisostomo said. It received another $800,000 in grants from the National Cancer Institute and others to fund its oncology trials. The trials support about 40 jobs.
The health system, however, sees no profit from the trials.
“We don’t make a profit of any sort because the money is used to cover the costs of the study and staff times,” Pattison-Crisostomo said.
The new industry report is helping the Minnesota Clinical Research Alliance, a coalition of the state’s medical research sector, raise awareness about the importance of clinical trials in helping patients and advancing medicine.
“We want to get more information out so patients see this as an option,” Trewhitt said. “If you’re a clinical treatment participant you get early access to important medicines.”
For the patient, participation in clinical trials is free. They are not charged for research-related procedures, medications and visits. And their progress is closely monitored.
Best candidates for the trials are those with a debilitating disease whose treatments aren’t working, said Trewhitt. The biggest area of clinical trials is in cancer research. And that’s where the greatest need for participants lies, the report shows.
“Cancer patients quite often are good candidates for clinical trials and yet fewer than 5 percent of cancer patients actually participate in clinical trials,” Trewhitt said. But for cancer patients where conventional treatments have failed, clinical trials may be their best choice for treatment, he said.
Essentia finds participants for its clinical trials though screenings, doctor referrals, support groups and through public calls for volunteers,
If a patient feels a clinical trial of a new treatment might be for them, they should first discuss it with their doctor, Trewhitt said.