[St. Lawrence Health Clinical Research Coordinator II Daniel Jaremczuk, CCRP, reviews the informed consent process with a clinical trial candidate.]
While most of us have heard about clinical trials for a drug or vaccination, we might not even realize some of these trials are taking place right here in the North Country through St. Lawrence Health (SLH).
Clinical Trials Day is Friday, May 20, 2022, and SLH Clinical and Rural Health Research Director Carly Lovelett, CCRP, noted it is a day set aside to recognize those who conduct and participate in clinical trials. The day also affords the opportunity to share education and awareness about research and the countless medical advances that have been made as a direct result of clinical trials.
“It is particularly important to celebrate Clinical Trials Day in the North Country because St. Lawrence Health’s Clinical and Rural Health Research Department is one of the relatively few non-academic health centers offering clinical trials in rural America. Throughout the COVID-19 pandemic, having an established research department allowed us to offer pivotal clinical trials to our patients. The investigative treatments involved in the trials were not yet available outside a clinical trial setting,” Ms. Lovelett stated.
The department is currently offering clinical trials for different diseases in Rheumatology, Pulmonology, and Neurology, in addition to an inpatient COVID-19 trial. If a patient comes across information on one of the SLH clinical trials that is underway, they can still join after the initial start-date as long as the study is open for enrollment. Ms. Lovelett and her team encourage interested individuals to reach out to them if they have questions about a particular trial and how long it might be open.
Taking part in a clinical trial may be beneficial to not only the participant, but to the population as a whole.
“Patients will be provided with the opportunity to potentially receive treatment for a disease before the treatment is widely available,” Ms. Lovelett said. “Furthermore, while they are playing an active role in their personal health care, they are also contributing to the advancement of research and medicine, which could benefit future patients.”
Participants are assured that all clinical trials through SLH are reviewed by multiple governing bodies to assess safety, and to ensure that potential benefits outweigh any potential risks.
“Safety is one of the most import aspects of running a trial. Safety is kept paramount throughout the process,” noted Clinical Research Nurse Coordinator Cameron Murray, RN.
Some patients may be concerned about side effects, but Ms. Lovelett reminds everyone that there are risks of side effects for any treatment, whether or not it is being provided in the setting of a clinical trial.
“Background information about the treatment, expectations, and potential risks and benefits are all discussed during the informed consent process. We want to assure each patient has all the necessary information to make the decision to participate or not. To minimize the risk of any side effects, we keep in close contact with our patients and encourage them to promptly report any changes in their health so the doctor overseeing the study can assess if it is related to the study drug, and if there is any need for a treatment change,” she explained.
After being involved in an SLH clinical trial, one participant stated, “I found everyone to be very professional, and they didn’t hesitate to explain anything when I questioned it. I did not have any side effects, and was very pleased that this treatment worked so well for me.”
The level of commitment requested of a patient varies across trials. An average trial will have monthly follow-up visits during a year of involvement. Research visits closely resemble normal physician appointments, and often include additional procedures that help researchers best understand the treatment involved in the study and how the patient is progressing throughout the trial. Most trials will provide compensation for time and travel associated with research visits.
At any point during the study a patient is allowed to stop participating from the trial, as participation in a clinical trial is always voluntary.
“A patient who is already enrolled in a trial can stop at any time, typically with the option to either stop the investigational treatment, but continue to come in for follow-up visits, or stop the investigational treatment and no longer have scheduled research follow-up visits,” Ms. Lovelett said.
When a clinical trial comes to its conclusion, many times participants stay in contact with the Clinical Research team members. The team and patients often form a lasting bond that is created through the study process.
“A lot of patients tell us they wish there were even more research opportunities for them to be involved in,” Mr. Murray said. “They have told me they appreciate the care provided to them during the trial and the accommodations made around their personal schedules. I have also heard many say they feel a real sense of accomplishment from contributing to medical science.”
While the SLH Research Department has expanded over the past seven years, one part of it that has not changed is the team’s dedication to serving their patients, and working for the betterment of our community.
“Since the inception of our department, we have consistently strived to bring high quality, safe, and innovative clinical trials to the therapeutic areas where patients need them most. We are looking forward to continuing to leverage our recent affiliation with Rochester Regional Health to bring a greater diversity of clinical trials and other research projects to the North Country,” Ms. Lovelett said.
Dr. McMillan noted he has always wanted to work in a hospital pharmacy, and he believes that completing a residency is the best way to continue on that path.
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