The Medical Minute: How clinical research studies benefit patients
Clinical research studies are the reason medical care has improved leaps and bounds in the past few decades.
Without these carefully-designed tests for new drugs, procedures or devices, treatments for diseases would not progress. These studies should be viewed as opportunities, although some people may view them negatively.
“We need to change the view from researching on people to providing opportunities for people to participate in research,” said Dr. Neal Thomas, associate dean of clinical research at Penn State College of Medicine. “Clinical research is necessary to advance medical care and is all about trying to further discoveries to find the best cure for a particular disease.”
Here is what the public should know about clinical studies:
Volunteers do not have to have a specific disease.
“You don’t have to be sick to be in a clinical research study,” said Terry Novchich, director of Penn State Hershey’s Clinical Trials Office. “We look for healthy volunteers for various studies depending on where we are in the development stage of that drug.” For example, Novchich said a new drug may be given to healthy volunteers before it's given to individuals who have that particular disease to test their reactions, or someone healthy could be studied to compare to someone with a disease.
Clinical studies offer crucial access for patients to cutting edge research.
In addition to providing scientists with information, clinical research studies often allow patients at academic medical centers like Penn State Hershey access to new and developing therapies that are not otherwise available.
“A small percentage of the patients in the United States are treated at places like Penn State Hershey,” Thomas said. “A lot of things that we do here are not offered at places that are not academic and don’t have an active clinical research program.”
Not all studies are the same.
Sometimes studies involve a medication, but others involve a device or new therapy. Some may be merely observational.
“We do a lot of research here where the patient never receives anything,” Thomas said. “They either just give information or they give samples of tissue or blood that allow scientists to help discover why things happen and then try to target therapies to that specific reason.”
A lot of the research studies conducted at the college are not trials at all but studies that lead to discovery.
There’s a reason for the experiments.
People may fear they or their loved one will be “experimented on.” Novchich and Thomas often hear potential study participants or their parents say they don't want to be a ‘guinea pig.'
“Part of our job is to explain that it’s not experimenting on someone just to experiment. It really is trying to find the best possible treatment for their specific disease,” Thomas said.
At a teaching hospital, each case is looked at as a learning opportunity to advance treatment and care for the next patient.
“A lot of people say even if this won’t help my child, if it could help the next generation of children that come through with this problem, then it’s worth it,” Thomas said.
Safety of participants is paramount.
According to Novchich, an independent institutional review board (IRB) ensures human subject protection during all studies. Patients always must consent to being part of a study, a process that is monitored locally by the Penn State Hershey IRB and overseen by federal regulations.
The potential risks and the benefits are outlined for each volunteer during a comprehensive consent process by members of the study team prior to participating in the research study.
Additionally, before a drug can be tested on humans, it often goes through years of development and any studies have to be approved by the Food and Drug Administration.
“They can be assured that the research is being done to answer an important scientific question and not being done just because we want to do research,” Thomas said. “The overarching goal is to improve the care of the patients that we treat, whether that’s the individual patient who is recruited for the research study or future patients with the same disease process.”
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The Medical Minute is a weekly health news feature brought to you by Penn State Milton S. Hershey Medical Center. Articles feature the expertise of Penn State Hershey faculty physicians and staff, and are designed to offer timely, relevant health information of interest to a broad audience.
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