Which of the following statements is true regarding the phase III clinical trial of a drug?
1) It is intended to determine drug efficacy and toxicity on a large number of patients
2) It is performed only on primates
3) It is performed with only a few volunteer subjects
4) It is primarily intended to determine the LD50 of a drug
📝 Explanation:
Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment.
MCQ