Before a clinical trial can start, the research team creates a research plan. The research plan is also called the “protocol”. The protocol describes:
- the length of the study
- the rules about who may or may not participate in the trial
- the schedule of tests, procedures, medications, and dosages
- the information the researchers want to collect about the treatment
A research team is assigned at each clinical trial location. The research team usually includes doctors, nurses, and other health care professionals.
The protocol is usually reviewed by an independent group of scientists and other professionals to help make sure that the study will be safe for the people with the disease or condition to participate in. Once the protocol is approved, the clinical trial can begin and participants can join.
During a clinical trial, the participants receive treatments and have tests done according to the protocol. Some trials compare a new treatment to a standard one that is already available. Other trials compare a treatment to a placebo. A placebo looks like a treatment but does not have any medicine in it. Some trials just look at a treatment without any comparisons.The research team collects information from the participants during the trial. This information helps them find out how safe and effective the treatments were in the trial.
Clinical trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.