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Volunteering for a clinical trial is a contribution to the future of medicine that only you can make!
Clinical research trials are critical because they allow doctors to develop the most safe and effective treatments.
Patients benefit by gaining access to promising new therapies for Systemic Lupus, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Gout, Fibromyalgia, Osteoarthritis and Osteoporosis.
If you have decided you would like to participate in a clinical research trial at our facility please contact our research department at (517) 272-9727 ext 124, or at email@example.com
The research staff will discuss with Dr. June if there is a protocol that would be right for you.
If there is a protocol that fits your needs you will be brought in for a visit called a screening visit.
If you fit all the criteria for the study you will be given an informed consent packet. This will include all the details of the trial. The informed consent will need to be signed by the patient and the doctor. The patient will be given a copy of the informed consent once all the required signatures are obtained.
A clinical trial is a research study designed to test the safety and efficacy of new treatments. All of the drug therapies available today had to be tested in clinical trials prior to being routinely used on patients. Dr. June and his staff have played a large role in developing many rheumatology treatments over the years.
There are many myths and misperceptions about participating in a trial. Volunteering does not make you a "guinea pig", it makes you a partner in discovery.
There would be no new drugs or treatments available for use without clinical research trials. All of our studies are under the auspices of the FDA.
Depending on the type of trial it is very likely you will see the Doctor and staff more often. You will also have more frequent testing done, like blood draws. This additional monitoring is very important, because it protects the safety of the patients enrolled in the study and helps collect data to tell if the treatment is working.
To ensure valid results, most trials are blinded so neither you or your doctor will know which type of medicine you will receive.
You have a legal right to withdraw consent from a trial at anytime for any reason.
Clinical trials are sponsored and funded by pharmaceutical companies, biotech companies, and federal agencies.
All costs of the trial is covered by its sponsor. Many of our trials provide payment for each visit, time, and travel, the amount is dependent upon the sponsor.
Trials are conducted in a series of steps called "Phases". Each phase is designed to answer a specific research question.
Phase I: Researchers test a new drug or treatment in a small group of patients for the first time to evaluate its safety and determine a safe dosage. Also any side effects can be identified at this time.
Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase III: The drug or treatment is again given to an even larger number of patients to confirm efficacy, monitor side effects, compare it to commonly used treatments and collect information that will allow the drug or treatment to be used safely.
Phase IV: Studies are done after the drug or treatment have been marketed to gather further information on the drugs effect in various populations and any side effects associated with long term use.
After each phase has been completed the data is collected to determine the drugs efficacy, if it's safe and if there are any side effects. After Phase III is completed researchers decide if the results are medically important and may submit them to journals for peer-review. Data then may be submitted to the Food and Drug Administration (FDA) for approval. If a drug is approved, pharmaceutical companies may continue to conduct studies that compare the new drug in terms of its safety, effectiveness and cost to other drugs already on the market. Pharmaceutical companies may also assess a drug's long term efficacy and it's impact on the quality of a person's life.