WHAT IS IT ALL ABOUT?
Clinical studies are designed to help people live healthier lives. The success of research depends on you as a volunteer. By taking part in a clinical research study, you can help researchers discover new medications that may benefit you, a family member or a friend.
WHAT IS A CLINICAL STUDY?
A clinical research study is a carefully controlled test of an investigational medicine to see if it works safely on a group of volunteers. This study may involve researching new uses for an already approved medicine. These studies are the only way for a medication to be available for use.
WHO IS IN CHARGE OF THE CLINICAL TRIAL?
Sponsors pay for clinical research studies. A sponsor can be a drug company, a private organization, or a government agency. These groups often work together to discover new and better medications.
STUDY DOCTOR AND STUDY COORDINATOR?
To conduct clinical research, sponsors work with health care professionals at study sites, such as a doctor’s office. The doctor in charge at the site is called the Principal Investigator. The Study Coordinator at the site is a health care professional who coordinates the study related activities.
WHY HAVE CLINICAL RESEARCH STUDIES?
Clinical research studies are conducted to see if the medicine is safe and effective. This testing is done in four phases.
Phase 1: Test safety and proper dosing.
Phase 2: Test if the medication is effective or causes any side effects.
Phase 3: Test if the medication is effective and is safe in a larger group of patients.
Phase 4: Done to collect more information after the medication has been approved by the FDA.
HOW DO DOCTORS AND RESEARCHERS TEST IF A MEDICATIONS WORKS?
Researchers compare an investigational medication to an already approved medication or a placebo. The placebo is often called a “sugar pill” because it has no active ingredients. In addition, it is made to look exactly like the medication being tested. It is very important that the results of the clinical research study are accurate. As a volunteer, you will not know what medication you are taking until the end of the study.