2. Although several therapeutic agents have been evaluated for the treatment of Covid-19, few antiviral agents...

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2. Although several therapeutic agents have been evaluated for the treatment of Covid-19, few antiviral agents have yet been shown to be efficacious. On October 22, 2020 the U.S. Food and Drug Administration fully approved (not just an Emergency Use Authorization) the first antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighting at least 88 pounds for the treatment of Covid-19 requiring hospitalizations. Several studies, including the following published in The New England Journal of Medicine: (https://www.nejm.org/doi/pdf/10.1056/NEJMoa2007764) led to this approval. Use the information from this final report to answer the following questions: a. Is this study observational or an experiment? How do you know? b. What was the primary outcome investigated in this study? c. The parameter of interest in this study was the median and not the mean. Taking into consideration what you know about when the median is used instead of the mean, why do you think in this study the medians were used? d. What evidence is there that this study attempts to minimize bias? e. How many subjects were part of this entire study? How many were part of each group? ly eri nts n in C 5 R and Pr f. This study found a significant difference between the median recovery time of the treatment group compared to the placebo group. Although not listed in the study, let's assume that the sample mean of the recovery time for those who received remdesivir was 10 days with a sample standard deviation of 2. Conduct the appropriate hypotheses test (a = .01 ) to determine if there is significant evidence that those given remdesivir recover on average sooner than 15 days (the average of the placebo group). State the null and alternate hypotheses. Compute the test statistic and draw a picture of the sampling distribution. Find the critical value and/or the p value. Make a decision and justify it using the critical value and/or the p-value. Record an appropriate conclusion in context of this problem. g. What does a Type I error mean in this situation? What are the consequences of making a Type I error in this specific scenario? h. What does a Type II error mean in this situation? What are the consequences of making a Type II error in this specific scenario? i. In this scenario, is a Type I or Type II error more serious? Or, are they equally serious? Explain your reasoning. j. If you were conducting this research, what alpha level would have you used? Explain your reasoning. k. What if the researchers in this problem wanted to estimate the population mean number of days to recovery when given remdesivir to be within 1 day? How many subjects would need to be part of the clinical trial if the population standard deviation is 2 days and they wanted to be 99% confident? 1010 2// 9 2. Although several therapeutic agents have been evaluated for the treatment of Covid-19, few antiviral agents have yet been shown to be efficacious. On October 22, 2020 the U.S. Food and Drug Administration fully approved (not just an Emergency Use Authorization) the first antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighting at least 88 pounds for the treatment of Covid-19 requiring hospitalizations. Several studies, including the following published in The New England Journal of Medicine: (https://www.nejm.org/doi/pdf/10.1056/NEJMoa2007764) led to this approval. Use the information from this final report to answer the following questions: a. Is this study observational or an experiment? How do you know? b. What was the primary outcome investigated in this study? c. The parameter of interest in this study was the median and not the mean. Taking into consideration what you know about when the median is used instead of the mean, why do you think in this study the medians were used? d. What evidence is there that this study attempts to minimize bias? e. How many subjects were part of this entire study? How many were part of each group? ly eri nts n in C 5 R and Pr f. This study found a significant difference between the median recovery time of the treatment group compared to the placebo group. Although not listed in the study, let's assume that the sample mean of the recovery time for those who received remdesivir was 10 days with a sample standard deviation of 2. Conduct the appropriate hypotheses test (a = .01 ) to determine if there is significant evidence that those given remdesivir recover on average sooner than 15 days (the average of the placebo group). State the null and alternate hypotheses. Compute the test statistic and draw a picture of the sampling distribution. Find the critical value and/or the p value. Make a decision and justify it using the critical value and/or the p-value. Record an appropriate conclusion in context of this problem. g. What does a Type I error mean in this situation? What are the consequences of making a Type I error in this specific scenario? h. What does a Type II error mean in this situation? What are the consequences of making a Type II error in this specific scenario? i. In this scenario, is a Type I or Type II error more serious? Or, are they equally serious? Explain your reasoning. j. If you were conducting this research, what alpha level would have you used? Explain your reasoning. k. What if the researchers in this problem wanted to estimate the population mean number of days to recovery when given remdesivir to be within 1 day? How many subjects would need to be part of the clinical trial if the population standard deviation is 2 days and they wanted to be 99% confident? 1010 2// 9