Definition: Comparative studies to verify the effectiveness of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques determined in phase II studies. During these trials, patients are monitored closely by physicians to identify any adverse reactions from long-term use. These studies are performed on groups of patients large enough to identify clinically significant responses and usually last about three years. This concept includes phase III studies conducted in both the U.S. and in other countries.
for general design, methodology, economics, etc. of phase III clinical trials; a different heading CLINICAL TRIAL, PHASE III is used for reports of a specific phase III clinical trial
Other names Evaluation Studies, FDA Phase III as Topic; Evaluation Studies, FDA Phase 3 as Topic; Drug Evaluation, FDA Phase III as Topic; Drug Evaluation, FDA Phase 3 as Topic; Clinical Trials, Phase 3 as Topic
