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91Ó°ÊÓ

In clinical trials of the drug Lipitor (atorvastatin), 270 subjects were given a placebo and 7 of them had allergic reactions. Among 863 subjects treated with \(10 \mathrm{mg}\) of the drug, 8 experienced allergic reactions. Construct the two \(95 \%\) confidence interval estimates of the percentages of allergic reactions. Compare the results. What do you conclude?

Short Answer

Expert verified
The confidence intervals overlap, suggesting no significant difference between the allergic reaction rates of the placebo and Lipitor groups.

Step by step solution

01

- Determine Sample Proportions

Calculate the sample proportion for each group. For the placebo group: \( p_1 = \frac{7}{270} = 0.0259 \)For the Lipitor group: \( p_2 = \frac{8}{863} = 0.0093 \)
02

- Find the Standard Errors

Compute the standard errors for both proportions. For the placebo group: \[ SE_1 = \sqrt{ \frac{p_1(1 - p_1)}{n_1} } = \sqrt{ \frac{0.0259(1 - 0.0259)}{270} } = 0.0097 \]For the Lipitor group: \[ SE_2 = \sqrt{ \frac{p_2(1 - p_2)}{863} } = \sqrt{ \frac{0.0093(1 - 0.0093)}{863} } = 0.0032 \]
03

- Calculate Confidence Intervals

Using the standard error and the z-score for a 95% confidence level (z = 1.96), calculate the confidence intervals. For the placebo group: \[ CI_1 = p_1 \pm z \cdot SE_1 = 0.0259 \pm 1.96 \cdot 0.0097 \]This results in: \[ 0.0259 \pm 0.019 \]Which gives the interval: \[ (0.0069, 0.0449) \]For the Lipitor group: \[ CI_2 = p_2 \pm z \cdot SE_2 = 0.0093 \pm 1.96 \cdot 0.0032 \]This results in: \[ 0.0093 \pm 0.0063 \]Which gives the interval: \[ (0.0030, 0.0156) \]
04

- Compare the Confidence Intervals

Compare the two confidence intervals. The interval for the placebo group is \((0.0069, 0.0449)\), whereas the interval for the Lipitor group is \((0.0030, 0.0156)\). There is an overlap in the confidence intervals, indicating no significant difference between the proportions of allergic reactions in the two groups.
05

- Conclusion

The comparison of the confidence intervals suggests that the proportion of allergic reactions for the placebo group may not be significantly different from that of the Lipitor group at the \(95\%\) confidence level.

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Key Concepts

These are the key concepts you need to understand to accurately answer the question.

Sample Proportion
In statistical analysis, especially in clinical trials, it is crucial to understand the concept of the sample proportion. A sample proportion (\( \hat{p}\)) represents the fraction of the sample that exhibits a particular attribute. For example, in the given trial, we used the sample proportion to measure allergic reactions.

To calculate the sample proportion, divide the number of individuals with the attribute by the total sample size. For the placebo group: \( \hat{p}_1 = \frac{7}{270} = 0.0259\) and for the Lipitor group: \( \hat{p}_2 = \frac{8}{863} = 0.0093\). This gives us a clear measure to proceed further.
Standard Error
The standard error (SE) is another fundamental concept in clinical trial statistics. It helps quantify the precision of the sample proportion. In other words, it indicates how much the sample proportion is likely to vary from the true population proportion.

To compute the SE for a proportion, use the formula:
\[ SE = \sqrt{\frac{\hat{p}(1 - \hat{p})}{n}}\] where \( \hat{p}\) is the sample proportion and \( n\) is the sample size. For the placebo group, the SE is: \( SE_1 = \sqrt{\frac{0.0259(1 - 0.0259)}{270}} = 0.0097\). Similarly, for the Lipitor group: \( SE_2 = \sqrt{\frac{0.0093(1 - 0.0093)}{863}} = 0.0032\).
This calculation gives insight into the variability of the results.
95% Confidence Interval
A confidence interval (CI) is a range of values within which we expect the true population parameter (like a proportion) to lie with a certain degree of confidence. In clinical trials, a 95% confidence interval implies that if we repeated the trial 100 times, we would expect the true proportion to lie within the interval in 95 of those trials.

To calculate a 95% CI for a sample proportion, use the formula:
\[ \hat{p} \pm z \cdot SE\]
where \( z = 1.96\) for a 95% confidence level.
For the placebo group: \( CI_1 = 0.0259 \pm 1.96 \cdot 0.0097 = 0.0259 \pm 0.019\), giving the interval: \( (0.0069, 0.0449)\).
For the Lipitor group: \( CI_2 = 0.0093 \pm 1.96 \cdot 0.0032 = 0.0093 \pm 0.0063\), giving the interval: \( (0.0030, 0.0156)\). These intervals provide a range for the possible true proportions of allergic reactions.
Comparison of Confidence Intervals
Comparing confidence intervals is a critical step in evaluating clinical trial results. By examining the overlap between the confidence intervals of different groups, one can determine if there is a statistically significant difference between them.

In our example, the placebo group has a CI of \( (0.0069, 0.0449)\), and the Lipitor group has a CI of \( (0.0030, 0.0156)\). The overlapping intervals indicate no significant difference in the proportions of allergic reactions between the two groups. This overlap means that the difference in proportions could be due to random variation.
Clinical Trial Statistics
Clinical trial statistics involve the application of statistical methods to analyze and interpret the data collected from clinical research. Key tasks include estimating population parameters, calculating standard errors, and constructing confidence intervals.

For instance, in our trial, statistical methods helped us compare the allergic reactions to a placebo and to Lipitor. Calculating the sample proportions, standard errors, and confidence intervals allows researchers to make informed decisions regarding the effectiveness and safety of a treatment.

By understanding and comparing the confidence intervals, researchers can draw conclusions about the treatment's impact and its potential side effects in the population. This process ensures that the findings are meaningful and reliable, helping to guide clinical practices and patient care.

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