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Pebc Statistics

In a 2-year randomized controlled trial comparing a new drug to a placebo: - 25% of patients who received the new drug achieved the desired clinical outcome, compared to 15% of patients who received the placebo. - The relative risk reduction of the new drug was calculated to be 40%. In a 3-year randomized controlled trial comparing a conventional therapy to a newly discovered drug: - A specific serious side effect occurred in 0.5% of patients receiving conventional therapy and 0.45% of patients receiving the new drug. - Based on these results, the minimum number of patients needed to receive the new drug for 3 years to statistically demonstrate prevention of at least one episode of the side effect is 2000

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0% found this document useful (0 votes)
362 views

Pebc Statistics

In a 2-year randomized controlled trial comparing a new drug to a placebo: - 25% of patients who received the new drug achieved the desired clinical outcome, compared to 15% of patients who received the placebo. - The relative risk reduction of the new drug was calculated to be 40%. In a 3-year randomized controlled trial comparing a conventional therapy to a newly discovered drug: - A specific serious side effect occurred in 0.5% of patients receiving conventional therapy and 0.45% of patients receiving the new drug. - Based on these results, the minimum number of patients needed to receive the new drug for 3 years to statistically demonstrate prevention of at least one episode of the side effect is 2000

Uploaded by

cesar138
Copyright
© Attribution Non-Commercial (BY-NC)
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Download as PDF, TXT or read online on Scribd
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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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