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Advancement, One Trial at a Time

Published April 2022 | In Spring 2022

New medications, updated medical equipment and the latest in treatment techniques don’t emerge out of the blue. It takes clinical research to perfect them.

Advancement, One Trial at a Time Media

Often when we think of the latest medical advancements, we imagine them emanating from metropolitan areas with prominent medical schools. What many fail to consider, is the role that clinical research plays in developing new medicines and treatments. Most people don’t know that Monument Health has an active clinical research team that partners with physicians to conduct clinical research right here in the Black Hills.

The clinical research conducted at Monument Health focuses on the use of new medications, new uses for existing medications, as well as new devices and therapies. Roger DeRaad, Director of Research, said that sometimes physicians will bring a trial to their attention if there is a new device or medication that they’re interested in working with or that they believe will help one of their patients. “Other times, research sponsors come to Monument Health to see if there is any interest in the studies, especially if they’ve worked with us in the past,” explained DeRaad.

The research studies are vital to developing new treatments, but they only work when there are participants. “Patients involved in clinical research are always volunteers,” said Crystal Gruetzmacher, Clinical Research Coordinator. “They give up their time — sometimes a good deal of time — and even though these trials are largely safe, the patients do assume some risk.”

“It’s important to understand that the only way that new medications can become available to everyone is if there are enough volunteers to participate in these studies,” adds DeRaad.  “Improvements in treatments and medications depend on clinical research and the patients that participate in them.”

“Whether they realize it or not, the patients who volunteer for these studies are changing and even saving lives,” adds Kelli McIntosh, Manager of Research.

Once the treatments and medications do become widely available, Monument Health physicians are already ahead of the learning curve, since they will have had previous experience with them.

“Sometimes you’ll see physicians shy away from new treatments or medications, simply because they don’t have experience with them yet,” says DeRaad. “That isn’t the case here. By the time many new medications are approved, our doctors aren’t just learning about them, they’ve already had five or even ten years of experience with them from participating in studies. New treatments are adopted into practice more rapidly and it keeps our physicians on the cutting edge of therapies.”

Are there any risks?

A lot of people may wonder if there’s any risk in participating in a clinical study. While there is a modicum of risk involved in any clinical trial, safety measures are built into the studies to mitigate any potential problems. “We know we need to be careful so, for example, in early phase studies with a new medication, there will be frequent contact and frequent lab work to identify any unexpected changes,” said DeRaad. “Sometimes during a trial, we’ll learn something new, and it may necessitate changing how often we treat or examine patients. And of course, we always explain the risks as we go along and ask if they wish to continue participating.”

Monument Health Clinical Research is always seeking participants in studies, but it’s important to remember that this isn’t a walk-in clinic. Participants must meet specific requirements for each study, and if you’re already a Monument Health patient, chances are your provider will let you know if there’s a study that’s right for you.

“A lot of people in the community may not be aware of it, but we’ve been doing clinical research here for 25 years,” says Roger DeRaad, Director of Research. “We’ve done somewhere around 400 different trials, and now we carry about 45 to 55 trials at any given time.”

Monument Health Clinical Research got its start in the ‘90s, with the establishment of the IRB Committee and the development of policies and procedures for performing studies and trials. In the early 2000s, the program had a fully established Human Research Protection Program and received Federalwide Assurance of compliance with U.S. federal regulations.

In 2013, the Clinical Research program earned accreditation with the Association for Accreditation of Human Research Protection Programs. AAHRPP accreditation indicates that an organization meets the standards for ethics, quality and protections for human research. “We’ve been doing clinical research in the Black Hills for 25 years now — that’s a lot of people that we’ve helped, directly and indirectly,” says Crystal Gruetzmacher, Clinical Research Coordinator.

“We’re very proud of the work we’ve done, and the length of time that we’ve been able to do it, but I have to mention that the Cancer Care Institute has also been doing research this whole time as well. In fact, they started before we did,” adds DeRaad. Clinical  Research started with focus on cardiac-related studies and trials — and two thirds of their research is still cardiac centered — but the program has continued to grow, expanding from cardiac-related research to also include endocrinology, rheumatology, pediatric, pediatric endocrinology, infectious disease, nephrology and cancer research.

The result of research

The long term impact of the studies is incredibly significant. “When we started 25 years ago we didn’t do stents in carotid arteries and we’ve kind of led the way in peripheral arterial stenting here,” DeRaad said. “About 20 years ago we went through numerous antiplatelet studies and now we have multiple effective anti-platelet therapies. We did the same thing with anticoagulation therapy. We went through 10 years of testing multiple anticoagulants and now we’ve got a wonderful array of anticoagulants.” Presently, two thirds of the research is cardiac related, and there is a big focus on a vast array of anti-cholesterol, lipid lowering drugs.

“We’re always learning new things, and we’re always excited for Monument Health to take part in new research,” said McIntosh. DeRaad adds, “About once a month we get notified of a new study that’s interesting, intriguing and challenging. There’s always something new — and potentially life-altering — just around the bend.

Doctors:
Roger Deraad
Director of Research

Crystal Gruetzmacher
Clinical Research Coordinator

Kelli Mcintosh
Manager of Research

While all clinical research carries some risk, measures are taken to protect participants from any harm. All studies involving new medications, new uses for existing medications or any new devices must be approved by the FDA and all clinical trials and research studies must be reviewed by the Institutional Review Board, or IRB.

The IRB is a committee established to review and approve any research involving human subjects to ensure all federal regulations are met, that the studies are ethically sound and that the rights of participants are protected.

The Monument Health IRB is committed to protecting the rights and welfare of the volunteer patients involved in research. The IRB reviews all plans for any research involving human subjects conducted at any Monument Health facility. The IRB members play an essential role in the research process and bring a variety of backgrounds and experience to the review of research applications.

Jen Hansen served as the IRB Coordinator for three years, a job that can be challenging at times, but that she ultimately found very rewarding. “When we review research applications, we always have the best interest of the volunteers at heart,” she says. “And when we see these studies, and get an understanding of how awesome the benefits of the research could be for people, it’s very exciting.”

Clinical research, trials and studies are necessary to develop new medicines, treatments, equipment and protocols that can save and drastically improve lives. But clinical research also benefits the Black Hills community in ways that may not be obvious at first glance.