Every medication prescribed by a physician has undergone rigorous testing through clinical trials prior to approval by the Food and Drug Administration. Without this testing, life-saving effects could not be made available to the general public.
By participating in clinical research trials, volunteers like Tim Miles of Midland play a crucial role in furthering advancements in medical therapy and technologies.
Miles’ participation in the trial technically started May 17, 2008. “That’s the day I had a heart attack,” he said. “I was alone at our cottage on Secord Lake but I knew what was happening and called 911.”
Luckily for Miles, a first responder happened to be less than two miles away when the call came through. “He got to me quickly and the next thing I know, we’re headed to the hospital in Midland.” Upon arrival at MidMichigan Medical Center – Midland, Interventional Cardiologist William Felten, M.D., performed a cardiac catheterization and put in two stents.
“I’ve done well since then. I see Dr. Felten at least once a year and he checks the tires and under the hood,” Miles said. “He recruited me into my first clinical trial about a year after my heart attack. I enjoyed the experience, so when asked to join another study, I said yes. I started the current trial in July 2014.”
Miles is currently participating in a trial investigating the effects of long-term treatment with a particular weight loss drug among patients who have had heart issues. The five-year trial is ongoing.
“I take a pill at breakfast and dinner, roughly every 12 hours, and I don’t know if I’m getting the actual medication or a placebo,” he said. “There hasn’t been any side effects, and I’ve even lost 80 pounds.”
The requirements of the trial are not at all cumbersome, Miles said. “I check in three times a year. Sometimes they draw blood, sometimes not. There are always questions to answer, and sometimes an echocardiogram,” he said. “It could take 20 minutes or a couple of hours but it’s worth it.”
He also keeps a daily, online record of everything he eats. Most importantly, Miles has taken full advantage of the online tools and educational materials provided by the trial.
He said the knowledge he gained about nutrition has been priceless. “I now have an understanding of basic nutrition,” Miles said. “I know how the body breaks down food and I understand metabolism and the role of exercise – a lot of little things for me, they had a big impact.”
When he first started using the online tools available through the trial, Miles calculated that if he ate 1,554 calories each day, he would lose 2.4 pounds a week. “There were weeks when I lost exactly 2.4 pounds,” he said. Now he aims for 1,500 – 1,600 calories a day and tries to get in 15 – 20 minutes of exercise as well.
“I’m a work process, detail-oriented person and to me, this is a process,” Miles said. As he refined his process, he saw and felt the results. “It wasn’t one big change, it was a hundred little changes.” For example, Miles said that before the trial, he would have put an unhealthy portion of mayo on an otherwise healthy, lean turkey sandwich. “Now, I think about the calories and opt for mustard instead.”
He said there has truly been no downside at all. “I feel better than ever,” Miles said. “I had a partial knee replacement years ago and it doesn’t hurt as badly as before. I’ve found that the more I exercise, the less pain I feel. The more I lose, the easier it is to move. The ease of mobility is a big plus.”
Health systems like MidMichigan Health are where most clinical research trials take place, as they offer one-on-one care and attention that leads to higher patient compliance. When patients stick to the requirements of a trial, longer studies can be conducted and more valuable data is collected. Clinical trials operate under strict safety guidelines. All risks must be explained to – and understood by – potential participants. They also follow a rigorous patient screening process.
MidMichigan conducts Phase II and Phase III studies, as well as outcome studies, meaning the trials involve testing drugs and treatments on larger groups of volunteers after a safe dosage and initial side effects have been identified. Registered nurse research coordinators screen MidMichigan’s cardiology patients for individuals who meet specific criteria for studies and then collaborate with patients and physicians for enrollment. Patients are regularly monitored, and data is collected that helps determine the effectiveness and safety of a treatment, including any different impacts across gender and race. Through the process, which is of no cost to volunteers, patients receive frequent medical care related to the clinical trial. Those who are interested in participating in a cardiovascular clinical trial may contact our office at (989) 631-2469 or cvresearch@midmichigan.org.
