WHAT IS A CLINICAL STUDY?
A clinical study is designed to understand whether an investigational treatment is safe and effective for people. There are usually several phases of a study, each designed to learn more about the investigational treatment’s effects. Clinical studies are divided into 3 phases:
Phase 1 is designed to gather information on safety and dosage
Phase 2 focuses on how well the medicine works
Phase 3 evaluates how well the medicine works and whether it is safe to take. The FDA uses this information during its consideration of approving the medication
All clinical studies must follow a strict set of rules that are outlined in the study’s protocol. These rules set specific requirements on which types of patients can be included in the study, procedures that must be followed, and the number of study visits required.
Because of these rules, it is important that participants carefully follow the visit schedule and instructions from the study staff. Clinical studies are required for all new treatments in order to show that the treatment is safe and effective before it can be made available to the general population.
WHY ARE CLINICAL STUDIES CONDUCTED?
Clinical studies are conducted to answer research questions and to learn if a certain investigational medicine is safe and effective. The main questions researchers want to answer are:
Does this investigational medicine work?
What, if any, side effects does this investigational medicine cause?
Do the benefits of the investigational medicine outweigh the risks?
Which patients are most likely to find this investigational medicine helpful?