Clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. Clinical research studies help researchers test whether a new potential medication is effective and safe for the general public.
Clinical research studies are sometimes referred to as “clinical trials.” Both mean the same thing.
How do clinical research studies work?
Before new medications become available on the market, they must go through rigorous testing before being approved by the FDA (Food and Drug Administration). There are many stages before a drug can be approved including both lab, animal, and human testing. Our site specifically conducts trials with patients who are suffering from specific conditions to evaluate the overall safety and effectiveness of an investigational medication. Throughout the study, you will be seen regularly by our clinical research team. We will check your current health and medical history, provide instructions about the trial, and carefully monitor your health during your participation in the research study.
Clinicaltrials.gov gives a great explanation here
What is Informed Consent?
Informed Consent occurs before you participate in a trial to make sure you understand the study, have all your questions properly answered, and learn about your rights as a study volunteer. This process helps you decide whether you want to become involved in a study and if it is in your best interest.
What are my rights as a study volunteer?
You can withdraw from a clinical study at any time and for any reason, even after signing the informed consent form. You also have the right to learn about new risks or findings that emerge throughout the study. If researchers learn that a treatment harms you, you will be immediately notified and withdrawn from the study.
Do I need Medical Insurance to Participate?
No. Health insurance is not required, nor is insurance information collected.
Is there any cost to participate?
No. All study related procedures and investigational medications are provided to you at no charge.
Is there compensation for my participation?
Most trials provide compensation for your time and travel.
What can you expect as a study volunteer?
Throughout the study you will regularly be seen by our clinical research team. We will go over your current health and medical history, provide instructions about the trial, and carefully monitor your health during your participation in the research study.
How do I know if I am eligible to participate?
Eligibility criteria differs from trial to trial. The criteria includes factors such as a patient’s age and gender, the type and stage of disease, and whether the patient has had certain treatments or has other health problems.
Eligibility criteria ensures that new approaches are tested on similar groups of people. This makes it clear to whom a clinical trial’s results apply. These criteria also are a safety measure. They ensure a trial excludes any people for whom the potential medication’s known risks outweigh any possible benefits.
How do I know if participating in a research trial is right for me?
We evaluate each patient individually to ensure you are a qualified candidate. Our doctors will collaborate with your doctors to make sure a clinical research study is the right path for your medical care. After a thorough review of your medical history and an evaluation of your lab work, one of our doctors will talk with you and decide if a trial is in your best interest.
There are several government agencies involved in regulating clinical research studies. These and other third parties also provide great additional information about clinical trials:
All clinical trials being conducted in the United States must be listed at www.clinicaltrials.gov. This is also a good resource for finding more trials being conducted in the area. All results of clinical trials must be posted on their website as well.
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