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Clinical Research Trials
Before a medication can be used on any individual for an illness or condition, it must be rigorously tested
in Clinical Research Trials. Clinical research trials are closely monitored through government
laws and regulations.
A medication must go through many levels of testing, or “phases” before it is considered safe and
effective for use on human beings for a specific illness. Tests are first performed in a laboratory by testing
on animal subjects for any potential unsafe effects.
The drug is then tested on normal, healthy human subjects for any side effects or unexpected problems. If the
medication passes this testing, it is then given to a small amount of patients, with their approval, for the illness
the drug was developed to treat.
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If the drug passes these phases of testing it goes into the third phase of testing is called Advanced
Clinical Research Trials. Sparrow, in partnership with Michigan State University, has many ongoing research trials to
offer patients with many types of health conditions, often including strokes.
Drug companies develop a strict protocol and guidelines before submitting to the Food and Drug Administration (FDA) for
their approval to begin testing the drug. Before offering clinical trial drugs to patients, a clinical research
trial team must seek approval from the institution or hospital’s Institutional Review Board (IRB).
The IRB is the board strong within the hospital or institution, made up of lay persons and doctors, who review all human
medical research protocols, guidelines, and information, before allowing research to be conducted. The research
provider must show proof that volunteers will be given full informed consent and the health of the patients is
monitored very closely for safety and efficacy.
There are two types of clinical research trials:
- The first one is a controlled trial, where one group of patients gets a new treatment or
drug while another control group gets the traditional treatment or drug. Often the control patients will get a placebo,
an inactive drug, instead of the investigational drug. The study will be double masked, in other words, neither the researcher,
the person who gives or prepares the drugs, or the patient, will know if the drug or a placebo has been given to the
patient. Therefore, no one will influence the outcome of either treatment.
- The second type is an open trial, where the treatment or drug is evaluated on its own and everyone involved will know
who received the clinical research trial treatment or drug. An investigational drug must be tested in large trials to evaluate the
effectiveness of the drug and any side effects, or their frequency, before it can be safely prescribed to any patient
presenting to a health care provider with an illness.
The Sparrow Stroke Team wants to provide their patients with all options of available care to improve the patient’s
outcome. For that purpose we participate with promising investigational drugs that are designed to improve the outcome
of a stroke. The research team rigorously scrutinizes any treatment modality or drug before seeking approval through the
IRB. Patients and families are offered any investigational drug available, when appropriate, as long as they meet the
criteria to use the drug and after thoroughly discussing pros and cons with the patient and family.
Informed consent is the written agreement the patient and family must sign after being fully
informed of the clinical research trial and it’s purpose.
Even after written informed consent a patient may withdraw from the study or request more information or have information repeated.
You will also be given a copy of your informed consent.
Often patients are provided with extra health care at no cost to them or their insurance company. Any costs or extra
care provided (lab tests, x-rays, office visits) involved in a clinical
research trial will be disclosed in the informed consent process.
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