A clinical trial is the scientific term for a test or study of a drug or medical device in people. These tests are done to see whether the product is safe and effective for people to use. Doctors and other health professionals run the tests according to strict rules set by the Food and Drug Administration (FDA). The FDA has established rules to make sure that people who agree to be in the studies are treated safely as possible.
Human volunteers participating in clinical trials answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find out treatments that work in people, and new ways to improve health.
There are different kinds of clinical trials, including those to study:
- Prevention options
- New treatments or new ways to use existing treatments
- New screening and diagnostic techniques
- Options for improving the quality of life for people who have serious medical conditions
Clinical trials are conducted according to a plan called a protocol. The protocol describes what type of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set out by the protocol.