Which of the following statements about Clinical trials is true?
Randomized controlled trial(RCT) is done for comparing new drug with standard therap in Phase 3. Post-marketing surveillance is done in Phase 4. Safety and no-toxicity is evaluated in Phase 1. Unit of study in Phase 1 is healthy human volunteers. Phase Unit of study Purpose PRECLINICAL PHASE Lab experiments Animals Pretesting CLINICAL PHASE Typical No. of patients Phase 0 Healthy human volunteers Micro - dosing Phase I Healthy human volunteers Safety and non - toxicity profile 10 to 30 usually healthy volunteers Phase II Patients Effectiveness Fewer than 100 Phase III Patients Comparison with existing drugs Hundreds or thousands Phase IV Patients Long term side effects Many thousands
Post-marketing surveillance is done in Phase 3
Safety and non-toxicity is evaluated in Phase 2
Randomized controlled trial in patients is done in Phase 3
Unit of study in Phase 1 is Patients
RCT, Trials