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BIOSTATISTICS MCQs

In an adequately powered, randomized controlled trial conducted over 2 years, the desired clinical outcome (i.e. prevention of a serious cardiovascular event) with a new drug is achieved in 25% of the study sample. In the patients who receive a placebo, only 15% obtain the same clinical benefit. The relative risk reduction achieved with the new drug over the study period is: a. 10%. b. 15%. c. 25%. d. 40%. e. 50%. there is a formula to calculate this. RRR = (EER-CER)/EER WHERE, RRR= RELATIVE RISK REDUCTION EER= EXPERIMENTAL EVENT RATE CER= CONTROL EVENT RATE(PLACEBO) RRR = 25-15/25 RRR= 0.4 since they asked for percentile we have to multiplied it with 100. so, FINAL ANSWER IS 0.4*100 = 40% In an adequately powered, randomized controlled trial conducted over 3 years, a specific serious side effect (i.e. reduction in leukocytes) with conventional therapy is seen in 0.5% of the study sample. In patients who receive a newly discovered drug, only 0.45% experience the same side effect. Based on these results, the minimum number of patients that would have to receive the new drug for 3 years to statistically demonstrate the prevention of one episode of this side effect in at least one patient is: a. 15. b. 20. c. 150. d. 200. e. 2000 THERE IS FORMULA FOR THIS ALSO: NNT= 1/ARR*100 WHERE, NNT= NO. NEEDED TO TREAT ARR= ABSOLUTE RISK REUCTION ARR= EER-CER ARR= 0.45-0.5 ARR= 0.05(negative sign means new drug is not more effective than previous one.) NNT= 1/0.05*100 NNT= 2000

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