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Copy file name to clipboardExpand all lines: vignettes/sampleSize_parallel.Rmd
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doc.cache <- T #for cran; change to F
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```
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In the following examples, we demonstrate the use of **SimTOST** for parallel trial designs with data assumed to follow a normal distribution on the log scale. We start by loading the package.
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In the following two examples, we demonstrate the use of **SimTOST** for parallel trial designs with data assumed to follow a normal distribution on the log scale. We start by loading the package.
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```{r, echo = T, message=F}
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library(SimTOST)
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```
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# Multiple Independent Co-Primary Endpoints
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We here consider a bio-equivalence trial with 2 treatment arms and $m=5$ endpoints. The sample size is calculated to ensure that the test and reference products are equivalent with respect to all 5 endpoints. The true ratio between the test and reference products is assumed to be 1.05. It is assumed that the standard deviation of the log-transformed response variable is $\sigma = 0.3$, and that all tests are independent ($\rho = 0$). The equivalence limits are set at 0.80 and 1.25. The significance level is 0.05. The sample size is determined at a power of 0.8.
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Here, we consider a bio-equivalence trial with 2 treatment arms and $m=5$ endpoints. The sample size is calculated to ensure that the test and reference products are equivalent with respect to all 5 endpoints. The true ratio between the test and reference products is assumed to be 1.05. It is assumed that the standard deviation of the log-transformed response variable is $\sigma = 0.3$, and that all tests are independent ($\rho = 0$). The equivalence limits are set at 0.80 and 1.25. The significance level is 0.05. The sample size is determined at a power of 0.8.
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This example is adapted from @mielke_sample_2018, who employed a difference-of-means test on the log scale. The sample size calculation can be conducted using two approaches, both of which are illustrated below.
For 80\% power, `r ssMielke["SS"]` subjects per sequence (`r ssMielke["SS"] * 2` in total) would have been required.
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For 80\% power, `r ssMielke["SS"]` subjects per sequence (`r ssMielke["SS"] * 2` in total) would be required.
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## Approach 2: Using sampleSize
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Alternatively, the sample size calculation can be performed using the [sampleSize()](../reference/sampleSize.html) function. This method assumes that effect sizes are normally distributed on the log scale and uses a difference-of-means test (`ctype = "DOM"`) with user-specified values for `mu_list` and `sigma_list`. Unlike the first approach, this method allows for greater flexibility in specifying parameter distributions.
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Alternatively, the sample size calculation can be performed using the [sampleSize()](../reference/sampleSize.html) function. This method assumes that effect sizes are normally distributed on the log scale and uses a difference-of-means test (`ctype = "DOM"`) with user-specified values for `mu_list` and `sigma_list`. This method allows for greater flexibility than Approach 1 in specifying parameter distributions.
For 80\% power, a total of `r ss$response$n_total` subjects would be required.
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As an alternative scenario, consider that the standard deviation of the log-transformed response variable is unknown, but the standard deviation on the original scale is known ($\sigma = 1$). In such cases, the [sampleSize()](../reference/sampleSize.html) function can still accommodate adjustments to handle these uncertainties by transforming parameters accordingly. We now provide all data on the raw scale, including equivalence bounds, and set `ctype = ROM` and `lognorm = TRUE`:
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Consider an alternative scenario in which the standard deviation of the log-transformed response variable is unknown, but the standard deviation on the original scale is known ($\sigma = 1$). In such cases, the [sampleSize()](../reference/sampleSize.html) function can still accommodate adjustments to handle these uncertainties by transforming parameters accordingly. We now provide all data on the raw scale, including the equivalence bounds, and set `ctype = ROM` and `lognorm = TRUE`.
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# Multiple Correlated Co-Primary Endpoints
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In the second example, we have $k=m=5$, $\sigma = 0.3$ and $\rho = 0.8$. This example is also adapted from @mielke_sample_2018, who employed a difference-of-means test on the log scale. The sample size calculation can again be conducted using two approaches, both of which are illustrated below.
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In the second example, we set $k=m=5$, $\sigma = 0.3$ and $\rho = 0.8$. This example is also adapted from @mielke_sample_2018, who employed a difference-of-means test on the log scale. The sample size calculation can again be conducted using two approaches, both of which are illustrated below.
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## Approach 1: Using sampleSize_Mielke
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In the first approach, we calculate the required sample size for 80% power using the [sampleSize_Mielke()](../reference/sampleSize_Mielke.html) function. This method directly follows the approach described in @mielke_sample_2018, assuming a difference-of-means test on the log-transformed scale with specified parameters.
For 80\% power, `r ssMielke["SS"]` subjects per sequence (`r ssMielke["SS"] * 2` in total) would be been required.
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For 80\% power, `r ssMielke["SS"]` subjects per sequence (`r ssMielke["SS"] * 2` in total) would be required.
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## Approach 2: Using sampleSize
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Alternatively, the sample size calculation can be performed using the [sampleSize()](../reference/sampleSize.html) function. This method assumes that effect sizes are normally distributed on the log scale and uses a difference-of-means test (`ctype = "DOM"`) with user-specified values for `mu_list`, `sigma_list`, and the correlation `rho`.
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Alternatively, the sample size calculation can be performed using the [sampleSize()](../reference/sampleSize.html) function. This method assumes that effect sizes are normally distributed on the log scale and uses a difference-of-means test (`ctype = "DOM"`) with user-specified values for `mu_list`, `sigma_list`, and the correlation parameter `rho`.
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