Last month, the Capitol hosted its first Clinical Trials Awareness Day showcasing some of the state’s 3,400 ongoing studies in an effort to educate the public.
While there are varied risks involved with each program, “These trials can speed the healing time or even cure a disease,” State Rep. Gail Haines said in a press release. Haines is the chair of the House Health Policy Committee and hopes to encourage future legislation making Michigan further research-friendly.
In brief, a clinical trial is a study proposed and funded by a sponsor company that aims to investigate a medication or evaluate a medical device—such as an artery stent or catheter—though a contract with the hospital and their staff.
A hospital’s clinical research team might consist of a coordinator who manages all studies, a physician, nursing staff, lab technicians and a selection of patients.
Admitted patients are chosen for clinical trial participation based on medical charts with supporting criteria showing they are a good fit, based on the study at hand.
Nurses will share the study with their patient and if interested, the patient can opt to be included in the clinical trial.
“It’s completely voluntary and you can withdraw at any time,” Elias Boueiri, cardiovascular research coordinator for Crittenton Hospital Medical Center said.
Calculating the risks and weighing the benefits
All trials conducted at Crittenton have been FDA approved, Boueiri said. “The risks are already measured and controlled.”
Often times, the patients involved in a study are already scheduled to undergo a particular procedure or begin a treatment. Signing a consent form grants permission to record how the patient responds to the product or procedure being studied, he said. Participating in a clinical trial simply allows medical personnel and sponsor companies access to results of your treatment for a continued database.
Since each study is different from the next, the risks depend on the particular procedure or medication being examined.
For instance, there might be the possibility of medication side effects. But there are side effects when taking Tylenol, he said, noting that most patients won’t exhibit a negative impact. A time commitment such as a follow-up phone call or office visit are also considered upon signing the involvement consent form.
But since the majority of Crittenton research includes cardiovascular trials, “With an organ as fragile as the heart, most of the risks could be really serious in case of a malfunction,” Boueiri said. “But so far, it’s been great.”
In contrast, the benefits range from more tailored patient treatment, access to a new medication or procedures prior to general availability and even some financial compensation.
Aside from possible individual gains, an overall goal of clinical studies is to improve future care for many patients.
At Crittenton, the majority of (but not solely) clinical research includes cardiovascular and catheter lab studies under the direction of Samer Kazziha, M.D., Boueiri said.
- Sapphire: post-approved extension study
One of the latest studies focuses on stenting for the carotid artery (found in the neck) using an elastic metal called nitinol.
A stent is an artificial tubular support surgically placed in an artery for instance that creates better blood flow in areas affected by stenosis, or abnormal narrowing of a passageway.
With high-risk stroke patients in mind, Kazziha’s team is following the efficacy of FDA-approved PRECISE stents made of nitinol that are flexible to meet the needs of an exposed and in-motion neck region. This particular metal expresses shape memory so it returns to original position and it is also insensitive to temperature—it will not expand nor contract.
Some other current projects include:
- BMC2 Peripheral Vascular Intervention (PVI) Quality Improvement Initiative
Commencing in August 2011, this clinical trial aims to improve patient care for those with peripheral vascular disease. Peripheral vascular disease involves any artery that is located away from the heart, typically in the legs, Boueiri said.
Clotting and arterial stenosis (or narrowing of arterial passageway) become the source of pain and is generally diagnosed in elderly patients. This study will help physicians and patients make better decisions when it comes to stents and treatment, he said by providing more information on the problem site.
- Abbott Nutrition BL01 Study
This clinical trial is a double-blinded study, which means neither the patient nor the medical staff administering the treatment know whether the patient is receiving the treatment or a placebo (fake and not influential) treatment to test the full accuracy of the study.
The trial aims to improve nutritional balance for elderly post-op patients who tend to be readmitted to the hospital due to secondary infection stemming from malnourishment, Boueiri said.
Patients receive an 8-ounce nutritional supplement for 90 days and hospital readmission rates are observed.
The magic words: “Chest pains”
Ralph Blackmore, 69, has been a Crittenton cardiac patient for a little more than a year. He is not a participating clinical trials patient but says he chooses Crittenton over other local hospitals as he currently lives in Roseville.
“When I had chest pains in Roseville, I drove over to the nearest hospital and wasn’t feeling too bad,” he said, “So I drove out to Crittenton.”
Blackmore has endured not only a heart attack in the past but a stroke, too.
“All the times I’ve been to emergency, they just take care of you. It’s been literally zero wait time—it just may have been coincidence but they seem to know how to operate here,” he said. “Unless my arm is falling off or something, I come out here.”
Kazziha and his team are always searching for more clinical trial patients. If you feel you may qualify and would like to participate in any of these ongoing studies, contact Elias Boueiri at firstname.lastname@example.org.
“We’re always open for more clinical trials,” Boueiri said. “And we always welcome any clinical trial that Dr. Kazziha finds beneficial to patients and intriguing to his practice.”