Question: Number of cases in Phase III clinical trials.

1. Please study the Measures for the Administration of Drug Registration, Appendix 2: Registration Classification and Application Data Requirements of Chemical Drugs: If it belongs to registration classification 3 or 4, it shall conduct pharmacokinetic studies and at least 100 randomized controlled clinical trials. For multiple indications, the number of cases for each major indication should be no less than 60 pairs. 2. According to the above requirements, if the comparison method of1:1:1:kloc-0/is adopted, the minimum number of qualified cases is 60: 60: 60. However, considering the shedding/withdrawal, it is usually enlarged by 20%, that is, 288 cases; 3. Because of the third phase experiment, the number of cases should meet the needs of statistics and analysis in addition to the requirements of laws and regulations. By the way, the place of origin is 3: 1, 1, two new drugs are used clinically, and the experimental group needs 100 cases in the second phase, so it is usually designed as 100: 100 cases. In the third stage, the experimental group needs 300 cases because the control drug is recognized as an effective drug. In this case, the usual design is 300: 100, that is, more than 3: 1. Discuss the minimum number of cases required by laws and regulations. The exact sample size needs to be calculated by statisticians according to the characteristics of drugs and diseases.