About Clinical Research Studies
What is a Clinical Research Study?
Clinical research studies (also called medical research and clinical trials) are used to determine whether new medications or treatments are both safe and effective. Carefully conducted clinical research studies are the fastest and safest way to find treatments that work.
What is Informed Consent?
The informed consent form states the purpose of the research study, a description of the experimental drug being used, duration of the study, and procedures to be performed (e.g. lab evaluations, office visits, x-rays, etc.) If you are considering joining a clinical research study, the research staff will give you informed consent documents that include the details about the study. Since joining a research study is an important decision, you should ask the research team any questions you may have.
Who Sponsors Clinical Research Studies?
Clinical research studies are sponsored by government agencies such as the National Institutes of Health (NIH), pharmaceutical companies, individual physician-investigators and health care institutions. A study can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.
What is a Double-blind or Double-masked Study?
A double-blind or double-masked study is one in which neither the participants nor the study staff know which participants are receiving the experimental treatment and which ones are getting either a standard treatment or a placebo. These studies are performed so neither the patients' nor the doctors' expectations about the experimental drug can influence the outcome.
What Will be Expected From me if I Participate in a Study?
The study team (physician and nurse) will ask the participant and a study companion to visit the research facility on a regular basis during the course of the study for monitoring and testing. In medication trials, participants will receive one of two or more therapies. One therapy may be a placebo (harmless compound). Participants will receive study related monitoring, study medications and laboratory services without cost for the duration of the study. Some studies may require regular laboratory studies such as blood samples, urine samples and MRI scans.
For more information regarding clinical research studies, go to ClinicalTrials.gov.
You can also read about a real patient's perspective of his participation in a research study in an article authored by Brock Yates. (Reprinted with permission of Vintage Motorsport magazine.)