MIMA Clinical Trial Research Benefits Community
By Ed Pierce // March 29, 2012
BREVARD COUNTY • MELBOURNE, FLORIDA – Participants in MIMA’s Century Research Program may not be aware of it, but they are helping save lives and bring revolutionary new treatments to the forefront of medicine.
The clinical research findings collected by the program are part of a process where new medications, devices, and diagnostic tests are determined to be safe and effective.
Following years of careful testing in laboratory animals, new medical products that pass rigorous requirements are cleared by the Food and Drug Administration for testing in humans. Some involve testing of pharmacological products by healthy volunteers to document the safety and effects of the product, while other tests study smaller numbers of patients for shorter and longer periods of time to confirm appropriate doses, treatments and products to more thoroughly understand possible side effects. These trials are the final level of testing before the FDA grants approval to new products.
Dr. Jorge Salazar leads MIMA’s Century Research Program and says the studies advance the cause of medicine.
“I am not a politician or an economist, but I bet there are dozens of layers in which our clinical research program directly or indirectly has a positive impact on our community and its people,” Salazar said. “The obvious contribution is helping establish the safety and efficacy of new medications, medical devices and diagnostic tests. The results of our work expand the options available to everyone in the world for preserving health and diagnosing and treating disease. More directly, it allows residents of the community access to specific treatments and interventions that would otherwise be unavailable or would require travel to a major medical center.”
He said another benefit from the program is physicians conducting the trials may apply what they have learned in the studies to treating other patients.
“This acts to raise the standard of care in our community,” he said. “We’re able to recruit high quality physicians here when the opportunity to participate in clinical research entices academically oriented physicians. Setting aside the health care benefits for the community, another area of indirect benefit is the economic impact of bringing research dollars here to pay for personnel and equipment. Our research trials provide employment and career-advancement opportunities to local citizens and anything that promotes job growth and local investment is a good thing.”
Over the years, MIMA physicians conducting clinical research have been published in more than 25 publications including the New England Journal of Medicine; Journal of the American Medical Association; LANCET; Journal of American College of Cardiology; and Journal of Stroke and Cerebrovascular diseases.
MIMA’s involvement in clinical trials has featured groundbreaking invasive interventions in carotid stenting, coronary artery stenting, cardiac pacemakers and defibrillators, orthopedic prosthetic implants, bariatric surgery and non-cosmetic uses of Botulinum toxin. The program also has tested many well-known medications like Lotrel; Lipitor; Diovan; Vytorin; Plavix; Advair; Tekturna; Foradil; Spiriva; and Pradaxa and resulted in FDA approval for many important, but less recognized treatments for cancer, Multiple Sclerosis, and Rheumatoid arthritis.
Currently there are 498 participants in MIMA clinical research trials in studies covering invasive cardiology; nuclear cardiology; osteoarthritis; diabetes; hyperlipidemia; Multiple Sclerosis; Rheumatoid arthritis; bariatric surgery; and colon cancer.
Helen Slaughter of West Melbourne, 72, was diagnosed with diabetes in 1999 and joined MIMA’s clinical trial program in 2009 at the suggestion of her primary care physician, Dr. Miguel Lorente.
She became a participant after meeting program qualifications and an interview. All of her lab tests and medical supplies are paid for and the information obtained from her results is strictly confidential.
“I didn’t like taking all this medicine for my diabetes,” Slaughter said. After the third program I was in, I began to feel much better. They encourage us to eat properly and to exercise. My whole outlook on my health has changed. In fact, many of my other health problems are better too. My heart is better and my cholesterol is down.
Slaughter receives insulin and other new medications and sees a physician weekly during each study, which typically lasts about 11 months.
“It’s been great for me,” she said. “When I started this, my best friend told me she didn’t want me to be a guinea pig. But after seeing the results, my family and friends think what I’m doing is great. I even told a man from church who was having health problems about the program and now he is participating.”
Salazar said Slaughter is just one example of a participant who has been helped significantly by the program.
“I could share innumerable stories of patients who benefitted tremendously because of their involvement in a clinical research trial,” he said. “One case immediately comes to mind of a middle-aged man with diabetes. He was really not able to follow the necessary diet and had many bad habits, including smoking and lack of exercise. He chose to participate in a two-year study of a new type of insulin. This was an intense study that required patients to be checked every week by phone and checked in person every two weeks.
“At first, he was perturbed with having to interact so much with the clinical research team, but he quickly came to realize that it was in his own best interest. As part of the study he received continued patient education regarding his disease. As a result, he began to improve his diet and started exercising. The research team kept encouraging him. By the end of the study, he was a changed man. He had lost 40 pounds, enjoyed a very healthy diet, had given up smoking and his diabetes was in perfect control. When he completed the study, he thanked us for saving his life.”
Salazar said the man’s insurance would never have covered the intensity of care that he received and he would not have been able to afford to pay for it individually.
“It’s been over a year since he completed the study and he is still taking great care of himself and his diabetes remains in excellent control,” he said.
Another case involved a clinical trial participant that reported mild new symptoms leading to the discovery that he had a progressive heart condition that had not been detected previously. He was able to have a lifesaving procedure performed before actually having a deadly event and his life was probably saved by his participation in the program.
Safety is paramount
In conducting research, MIMA’s physician investigators first learn about the study and the investigational product through reading important documents including the investigator’s brochure and the study protocol. They then carefully evaluate prospective patients to ensure that it is safe for them to participate in the study and that they meet the study requirements. During the course of the study, the investigators oversee other clinical research staff that take measurements and collect data. They review all diagnostic test results and evaluate any signs and symptoms that patients might develop to determine severity and any possible relationship with the study product.
“At all times, the safety and well-being of the patient is paramount,” Salazar said. “Investigators often have to communicate with the patients and other physicians to insure the patient receives proper treatment and to help physicians understand the implications of the investigational product.”
Clinical research data collected is combined with those at other centers involved in the study and then reviewed and analyzed to reach scientifically sound conclusions about the product being tested.
Karen Federico is the clinical research manager for MIMA and said she believes the program’s success is a credit to everyone involved.
“We are always looking not only at testing, but finding new treatments,” she said. Those who are actively involved are at the cutting edge of science and bringing that to MIMA. Patients are able to get care and medicine that they may not be able to afford without being in a clinical trial.”
She said MIMA’s clinical trial research programs are open to everyone of all ages and from all walks of life. One pediatric study currently under way is for babies just age 1 and under, while others have tested adults in their 90s.
“We reach out to area physicians and tell them what we are studying and get very good response,” Federico said. “It’s a win-win for everyone. Those who participate in these trials change lives for the better.”
Salazar said MIMA has been working with the Brevard County Health Department and Brevard Health Alliance to offer their patients the option of participating in its clinical trials.
“Those patients that choose to participate will personally benefit from the rewards of participating,” he said. “The agencies also benefit because the clinical trial will cover costs involved in patient treatment. The trials will provide patient education and other benefits to the patients that the agencies would otherwise have to provide. This saves resources for the agencies allowing them to expand the services they provide or number of patients covered.”
He pointed out that MIMA also is involved in a partnership with Health First to bring important clinical trials to hospital settings.
“This acts to expand the skills of hospital personnel and bring the latest devices and procedures to our community hospitals,” Salazar said. “We are also working with the University Of Central Florida School Of Medicine to collaborate in clinical research studies. This will further enhance the availability of clinical trials to members of our community as well as creating access to medical experts at the medical school.”