Clinical Trials at Archbold
Thursday, May 30, 2013
If you’re like most people, the words “clinical trials” provoke thoughts of a laboratory filled with beakers, stirring rods and microscope slides at a large medical research facility or a teaching hospital in a big city.
The reality is clinical trials take place every day—in South Georgia—at Archbold’s Loudermilk Heart and Vascular Center and Lewis Hall Singletary Oncology Center.
And it’s Archbold physicians that work closely with local patients who volunteer to participate in the research of the latest medical advancements available—procedures and medication—that have the potential to help thousands of patients worldwide combat cancer and heart disease.
According to the US National Institutes of Health, a clinical trial is performed to determine the safety and efficacy of a specific intervention—such as medical products like drugs, devices, procedures, or even changes to participants' behavior (for example, diet)—by measuring certain outcomes in participants.
When a new medical product or approach is being studied, it is not usually known whether it will be helpful to the patient, or perhaps any different than currently available alternatives, including no intervention at all.
“We currently have 46 patients enrolled in 12 unique clinical trials, six of which are clinical treatment trials and six that are registries,” said Singletary Oncology Center administrator Bill Tustin. “Our physicians are well respected in the research industry and their relationships with prominent pharmaceutical organizations have landed us research partnerships with Amgen, Eli Lilly and XBiotech, just to name a few.”
Since the oncology clinical trials program began at Archbold in 1995, several Archbold medical oncologists including, Brian E. Gaupp, MD, Teresa Coleman, MD, and radiation oncologist Steven Johnson, MD, have led research initiatives serving as principal investigators for different treatment trials.
“Studies have shown that patients who participate in clinical trials have better treatment outcomes,” said Coleman. “As physicians, we’re dedicated to providing our patients the same latest treatments offered in larger cities, so they don’t have to travel.”
But what’s interesting about the program is regardless the physician you see at the Singletary Oncology Center, every patient has the opportunity to participate in clinical trials. In fact, every patient is screened to determine if they meet the criteria for inclusion.
“It’s really incredible what the patients in our region have access to through Archbold,” said Coleman.
And Archbold’s track record for success with clinical trials is why the hospital’s research program continues to grow.
“Because of our relative size, we have an intimate and well-controlled setting for research,” said interventional cardiologist Clay Sizemore, MD. “But it’s the performance of our physicians and staff, and our success in achieving great results and obtaining clean data that make Archbold appealing as a site for industry-based clinical trials.”
Recently, Archbold completed a carotid stent trial with the large pharmaceutical and medical device company Abbott Vascular, focusing on patients deemed high risk for carotid surgery.
“The purpose of this trial was to collect data on the clinical outcomes of high risk patients undergoing minimally invasive catheter-based therapy (carotid stenting) to treat carotid stenosis, a blockage or narrowing of the carotid artery in the neck,” said Sizemore. “Because of their “high risk” nature, these patients would have had very limited treatment options prior to the availability of the study.”
Sizemore added that because of Archbold’s success with Abbott’s carotid stent trial and its unique multidisciniplanary approach, the hospital was recently invited to participate in an expanded carotid stent study with the company that evaluates the safety and effectiveness of using minimally invasive catheter-based therapy to treat patients considered “normal” risk for traditional surgery, thus further expanding patients’ treatment options. The hospital is currently enrolling patients in this study.
Archbold’s cardiology program introduced clinical trials in 2005, when the Loudermilk Heart and Vascular Center was one of ten hospitals in Georgia chosen to participate in the second phase of the Cardiovascular Patient Outcomes Research Team clinical trial (C-PORT medical trial), a national study launched by Johns Hopkins.
“The randomized clinical trial compared outcomes of elective coronary intervention procedures as well as emergency coronary intervention procedures to determine the safety and effectiveness of angioplasty and stent placement, or percutaneous coronary intervention (PCI), at community hospitals without onsite cardiac surgery,” said Ken Brooker, Archbold vice president for clinical services.
Archbold enrolled a total of 995 patients in the C-PORT trial—574 Archbold patients were in the elective study and 421 emergency cases were submitted to the registry.
In 2011, Archbold was chosen to participate in a study with a pharmaceutical company to test the use of monoclonal antibodies, one of the first true human antibodies used to treat restenosis—a recurrence of the narrowing of a vessel after it's been opened by a stent or surgery. Archbold was the leading enrollment site for the study, enrolling more patients than any other hospital, despite participation from several large university-based institutions.
And opportunities for trials at Archbold continue to grow.
According to Sizemore, Archbold is also participating in a trial that evaluates a novel treatment protocol which reduces the duration of intravenous (IV) blood thinners, with the intent of reducing bleeding complications.
“A patient's risk of bleeding is an important factor when determining the appropriate treatment approach,” said Sizemore. “We believe the choice of blood thinner and protocol of administration can potentially lead to a reduction in bleeding complications for patients undergoing coronary intervention, and that’s what we’re looking at during this study.”
Coleman and Sizemore credit Archbold’s unique nature of collaborative effort for the hospital’s success with clinical trials.
“Collaboration is critical to ensure successful outcomes in clinical research,” said Coleman. “It’s our organization’s dedication to our patients and our physicians’ and staff’s passion for discovering the best and latest treatments that help make our research program successful.”
“What makes Archbold unique is how all the disciplines work together to put our patients first,” said Sizemore. “Our interdisciplinary team of cardiologists, interventional cardiologists, vascular interventionalists and vascular surgeons are committed to providing and helping to refine unique cardiology and vascular treatments that otherwise would not be available in a community this size.”
Coleman added, “And importantly, treatment breakthroughs can’t happen without the patients who choose to participate in clinical trials.”
“We are firmly committed to continuing to building a strong research infrastructure of highly qualified physicians, nursing staff, and technical support. As a result we fully anticipate an even stronger ongoing relationship with our academic and industry partners that will allow us to stay at the forefront of science and technology, and most importantly help more patients in the process,” said Sizemore.