Expanded controlled and uncontrolled studies. They are performed after preliminary evidence of drug effectiveness has been obtained. They are intended to gather additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide adequate basis for physician labeling. These studies usually include anywhere from several hundred to several thousand subjects.
Phase III studies are large double-blind randomized controlled trials on large patient groups (1000-3000 or more) and are aimed at being the definitive assessment of the efficacy of the new therapy, especially in comparison with currently available alternatives.
In Phase III, the new treatment is compared with commonly used treatments and monitored for long-term side effects.
The third phase of clinical trials. Large groups of participants are enrolled in this study phase. The goal is to confirm effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling.
Large clinical studies of new drugs to confirm their efficacy and risks and compare them with existing drugs, usually in people with medical conditions. FDA approval can occur after Phase III trials.
test the effectiveness and side effects of a new drug, combination of drugs or procedure in a larger patient group. This phase usually requires a large number of participants.
Expanded controlled and uncontrolled trials intended to generate additional information about overall, efficacy and benefit-risk relationship of the drug and to support product approval and labeling.
