# A clinical trial

###### A fundamental ethical problem in statistics
September 27, 2019
###### environmental issues
September 27, 2019

Question

# 1. A clinical trial is conducted comparing a new pain medication for arthritis. Participants are randomly

assigned to receive the new medication or a placebo. The outcome is pain relief within 30 minutes. The data are shown below. Pain Relief No Pain Relief New Medication 44 76 Placebo 21 99 Estimate the risk difference in pain relief between treatments = Estimate the relative risk in pain relief between treatments = Estimate the odds ratio in pain relief between treatments = The upper and lower limits of the are shown below Lower Limit of CI: _______ Upper Limit of CI: ________ Based on the Confidence Interval values which of the following are true? A. One can be 95% confident that the true value will be greater than the upper limit. B. One can be 95% confident that the true value will be greater than the lower limit. C. One can be 95% confident that the true value will between the upper and lower limit. D. a and b 2. The following data were collected in a clinical trial evaluating a new compound designed to improve wound healing in trauma patients. The new compound is compared against a placebo. After treatment for 5 days with the new compound or placebo the extent of wound healing is measured and the data are shown below. Percent Wound Healing Treatment 0-25% 26-50% 51-75% 76-100% New Compound (n=125) 15 37 32 41 Placebo (n=125) 36 45 34 10 Is there a difference in the extent of wound healing by treatment? (Hint: Are treatment and the percent wound healing independent?) Run the appropriate test at a 5% level of significance. df= ________ alpha= _______ Reject H0 if χ2> ________ Compute expected frequencies Expected Frequency = (Row Total * Column Total)/N. Complete the expected frequencies for each cell. Percent Wound Healing Total Treatment 0-25% 26-50% 51-75% 76-100% New Compound 15 37 ( ) 32 () 41 ( ) 125 Placebo 36 (25.5 ) 45 ( ) 34 ( ) 10 () 125 Total 51 82 66 51 250 Compute χ2. χ2= ______ Based on comparing the computed χ2 to the rejection level χ2 which of the following is (are) true? A. We have statistically significant evidence at alpha=0.05 to show that H0 is false. B. Treatment and percent wound healing are not independent. C. Treatment and percent wound healing are independent. D. a and b. 3. A clinical trial is conducted comparing a new pain reliever for arthritis to a placebo. Participants are randomly assigned to receive the new treatment or a placebo and the outcome is pain relief within 30 minutes. The data are shown below. Pain Relief No Pain Relief New Medication 44 76 Placebo 21 99 Is there a significant difference in the proportions of patients reporting pain relief? Run the test at a 5% level of significance. Reject H0 if Z < _______ or if Z > ________ alpha= ________ = ________ = ________ = ________ Z = _______ Based on comparing the computed z to the rejection level z which of the following is (are) true? A. We have statistically significant evidence at alpha=0.05 to show that H0 is false. B. We have statistically significant evidence at alpha=0.05 to show that there a significant difference in the proportions of patients reporting pain relief. C. We do not have statistically significant evidence at alpha=0.05 to show there a significant difference in the proportions of patients reporting pain relief. D. a and b

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