These trials provide information about how well a drug works, and generates more information on the safety and benefit of the drug. A Phase III trial is held to see if the current practice is the best way to treat a patient, or if a new drug treatment or device provides better treatment. Phase III trials compare a new drug, combination of drugs, or procedure with a current standard of treatment. Several different hospitals or centers may be involved in the study, but they all follow one set of plans and rules. These plans and rules include what is to be studied, who may take part in the study, what medicines and tests will be used, and what information is being gathered.
Clinical trials enroll people who are alike in certain ways depending on the rules of the study.
These rules are found under the eligibility criteria section of a protocol. The eligibility criteria list the person's characteristics necessary to be in the study such as the type of disease, age limit of people involved and their general health. Clinical trials have several steps they must pass through to ensure a participant gets careful medical attention. One or more review groups have to approve the protocol for each study before a patient is asked to participate. The IRB is made up of doctors, other health care providers, consumers and sometimes members of the clergy, who do not have any personal interest in the results of the study.