What does participating in a clinical trial involve?
First, you are educated about the drug being tested, with comprehensive review of the procedures performed, descriptions of the potential benefits and side effects, as well as answering any questions about the study, disease or disorder.
After review of the consent form(which contains the details of the study), and you decide to participate, the screening process begins.
During the screening period, information is gathered and tests are performed to determine whether you are eligible to participate. If eligible, then you are then enrolled into the study to receive the investigational product.
Once entered into a clinical trial, you are typically randomized(randomly selected) to receive the study medication. The study medication(per the study) may be active drug with one or multiple dosages, or a placebo (a substance that looks exactly like the active study medication but has no medicinal effects). The consent will cover the treatment arms.
You, the research staff and your doctors will not know which drug or dosage you are actually receiving. But in cases of emergency, it can be obtained.
Follow up visits will be listed in the consent along with the frequency of the visits. The follow up visits are conducted to monitor your progress, assess side effects, and will include testing and/or questionnaires etc to evaluate your health status during the trial up to the final study visit.
A research study can last for a few weeks to as many as 2 years. Each study had different requirements and be reviewed with you during the consent visit.