Introduction to Clinical Trials
What is a Clinical Trial?
Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.
Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Some studies need volunteers with a certain disease, while others may need healthy people. In the United States, an independent committee of physicians, statisticians and members of the community must approve and monitor the protocol. They make sure that that the risks are small and are worth the potential benefits.
What is the purpose of a Clinical Trial?
A clinical trial's main goal is to learn, not to treat. Researchers worldwide utilize clinical trials to assess the efficacy of medications in comparison to placebos or other treatments. More so some clinical trials will be testing various treatment regimens of existing medications. All this information is available to you upon request for any study you may wish to participate in.
Is it safe?
All trial medication must reach a certain level of safety and tolerability before being used in human trials. The trials themselves are strictly monitored for proper procedure and welfare of the patients. However, as with any trial medication risks are involved and side effects may occur. There will be a list of known side effects available for your review before you reach any decision.
What happens during a study visit?
It depends on the study! For most studies, there is a standard set of procedures that are completed at each visit, but this may vary. Prior to making a decision on whether or not you would like to participate in a particular study, you can ask your Study Coordinator or Recruitment Specialist for the Informed Consent Form (ICF), which outlines which procedures you can expect during each visit. Check out the Study Procedures page to see a list of common procedures during a study visit.