Which of the following statements about Clinical trials is true?
Correct Answer: Randomized controlled trial in patients is done in Phase 3
Description: 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
Category:
Social & Preventive Medicine
Get More
Subject Mock Tests
Practice with over 200,000 questions from various medical subjects and improve your knowledge.
Attempt a mock test nowMock Exam
Take an exam with 100 random questions selected from all subjects to test your knowledge.
Coming SoonGet More
Subject Mock Tests
Try practicing mock tests with over 200,000 questions from various medical subjects.
Attempt a mock test now