Definition: Studies that are usually controlled to assess the effectiveness and dosage (if appropriate) of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques. These studies are performed on several hundred volunteers, including a limited number of patients with the target disease or disorder, and last about two years. This concept includes phase II studies conducted in both the U.S. and in other countries.
for general design, methodology, economics, etc. of phase II clinical trials; a different heading CLINICAL TRIAL, PHASE II is used for reports of a specific phase II clinical trial
Other names Evaluation Studies, FDA Phase II as Topic; Evaluation Studies, FDA Phase 2 as Topic; Drug Evaluation, FDA Phase II as Topic; Drug Evaluation, FDA Phase 2 as Topic
