An investigator wants to know the total number of participants for a clinical trial to test...

 

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An investigator wants to know the total number of participants for a clinical trial to test the efficacy of a novel intervention compared to a standard treatment among diabetes patients. Assuming the critical level of 0.05 and 80% power, he found 100 patients are needed if all patients are independent. But he is planning to use a parallel-arm group randomized trial design because he will recruit patients from clinics (i.e., patients will be nested in clinic). He selects 5 clinics and plans to recruit equal number of patients from each clinic. If the intraclass correlation coefficient of clinic is 0.25, how many patients will be needed based on the sample size he has calculated under the assumption that all patients are independent? A. 400 B. 500 C. 200 D. 100 E. 250 An investigator wants to know the total number of participants for a clinical trial to test the efficacy of a novel intervention compared to a standard treatment among diabetes patients. Assuming the critical level of 0.05 and 80% power, he found 100 patients are needed if all patients are independent. But he is planning to use a parallel-arm group randomized trial design because he will recruit patients from clinics (i.e., patients will be nested in clinic). He selects 5 clinics and plans to recruit equal number of patients from each clinic. If the intraclass correlation coefficient of clinic is 0.25, how many patients will be needed based on the sample size he has calculated under the assumption that all patients are independent? A. 400 B. 500 C. 200 D. 100 E. 250

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There are four types of simultaneously controlled trials that give evidence of efficacy according to the Food and Drug Administrations requirements on sufficient and wellcontrolled research 21 CFR 314... View the full answer