# Non-Inferiority Tests for Two Means using Differences

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1 Chapter 450 on-inferiority Tests for Two Means using Differences Introduction This procedure computes power and sample size for non-inferiority tests in two-sample designs in which the outcome is a continuous normal random variable. Measurements are made on individuals that have been randomly assigned to one of two groups. This is sometimes referred to as a parallel-groups design. This design is used in situations such as the comparison of the income level of two regions, the nitrogen content of two lakes, or the effectiveness of two drugs. The two-sample t-test is commonly used with this situation. When the variances of the two groups are unequal, Welch s t-test may be used. When the data are not normally distributed, the Mann-Whitney (Wilcoxon signed-ranks) U test may be used. The details of sample size calculation for the two-sample design are presented in the Two-Sample T-Test chapter and they will not be duplicated here. This chapter only discusses those changes necessary for non-inferiority and superiority tests. Sample size formulas for non-inferiority and superiority tests of two means are presented in Chow et al. (003) pages The Statistical Hypotheses Both non-inferiority and superiority tests are examples of directional (one-sided) tests and their power and sample size could be calculated using the Two-Sample T-Test procedure. However, at the urging of our users, we have developed this module, which provides the input and output in formats that are convenient for these types of tests. This section will review the specifics of non-inferiority and superiority testing. Remember that in the usual t-test setting, the null (H0) and alternative (H) hypotheses for one-sided tests are defined as H 0 :µ µ D versus H :µ µ Rejecting this test implies that the mean difference is larger than the value D. This test is called an upper-tailed test because it is rejected in samples in which the difference between the sample means is larger than D. Following is an example of a lower-tailed test. H 0 :µ µ D versus H :µ µ on-inferiority and superiority tests are special cases of the above directional tests. It will be convenient to adopt the following specialized notation for the discussion of these tests. > D < D 450-

2 Parameter PASS Input/Output Interpretation µ ot used Mean of population. Population is assumed to consist of those who have received the new treatment. µ ot used Mean of population. Population is assumed to consist of those who have received the reference treatment. M I IM Margin of non-inferiority. This is a tolerance value that defines the magnitude of the amount that is not of practical importance. This may be thought of as the largest change from the baseline that is considered to be trivial. The absolute value is shown to emphasize that this is a magnitude. The sign of the value will be determined by the specific design that is being used. δ D True difference. This is the value of µ µ, the difference between the means. This is the value at which the power is calculated. ote that the actual values of µ and µ are not needed. Only their difference is needed for power and sample size calculations. on-inferiority Tests A non-inferiority test tests that the treatment mean is not worse than the reference mean by more than the equivalence margin. The actual direction of the hypothesis depends on the response variable being studied. Case : High Values Good, on-inferiority Test In this case, higher values are better. The hypotheses are arranged so that rejecting the null hypothesis implies that the treatment mean is no less than a small amount below the reference mean. The value of δ is often set to zero. The following are equivalent sets of hypotheses. H : µ µ M I versus H : µ µ M I 0 > H : µ µ M I versus H : µ µ > M I 0 H 0 :δ M I versus H :δ > M I Case : High Values Bad, on-inferiority Test In this case, lower values are better. The hypotheses are arranged so that rejecting the null hypothesis implies that the treatment mean is no more than a small amount above the reference mean. The value of δ is often set to zero. The following are equivalent sets of hypotheses. H µ 0 : µ + M I versus H : µ < µ + M I H µ 0 : µ M I versus H : µ µ < M I H :δ versus H :δ < M I 0 M I 450-

3 Example A non-inferiority test example will set the stage for the discussion of the terminology that follows. Suppose that a test is to be conducted to determine if a new cancer treatment adversely affects mean bone density. The adjusted mean bone density (AMBD) in the population of interest is gm/cm with a standard deviation of gm/cm. Clinicians decide that if the treatment reduces AMBD by more than 5% ( gm/cm), it poses a significant health threat. The hypothesis of interest is whether the mean AMBD in the treated group is more than below that of the reference group. The statistical test will be set up so that if the null hypothesis is rejected, the conclusion will be that the new treatment is non-inferior. The value gm/cm is called the margin of non-inferiority. Test Statistics This section describes the test statistics that are available in this procedure. Two-Sample T-Test Under the null hypothesis, this test assumes that the two groups of data are simple random samples from a single population of normally-distributed values that all have the same mean and variance. This assumption implies that the data are continuous and their distribution is symmetric. The calculation of the test statistic for the case when higher response values are good is as follows. where t df ( X X) s X X ε X k k X i k ki s X X ( X i X) + ( X i X ) i i + + df + The null hypothesis is rejected if the computed p-value is less than a specified level (usually 0.05). Otherwise, no conclusion can be reached. Welch s T-Test Welch (938) proposed the following test when the two variances are not assumed to be equal. t * f ( X X ) s * X X ε 450-3

4 where s * X X ( X i X) ( ) i + i ( X i X ) ( ) f s s + 4 s s + ( ) ( ) 4 s ( X i X) i, s ( X i X ) i Mann-Whitney U Test This test is the nonparametric substitute for the equal-variance t-test. Two key assumptions are that the distributions are at least ordinal and that they are identical under H0. This means that ties (repeated values) are not acceptable. When ties are present, you can use approximations, but the theoretic results no longer hold. The Mann-Whitney test statistic is defined as follows in Gibbons (985). where W ( ) Rank X k k W ( + + ) + C z The ranks are determined after combining the two samples. The standard deviation is calculated as s W s W 3 ( ti ti ) ( + + ) i ( + )( + ) where t i is the number of observations tied at value one, t is the number of observations tied at some value two, and so forth. The correction factor, C, is 0.5 if the rest of the numerator is negative or -0.5 otherwise. The value of z is then compared to the normal distribution

5 Computing the Power Standard Deviations Equal When σ σ σ, the power of the t test is calculated as follows.. Find t α such that Tdf ( tα ) α, where Tdf ( tα ) df +.. Calculate: σ σ x + ε δ 3. Calculate the noncentrality parameter: λ σ 4. Calculate: Power Tdf,λ ( tα ), where T ( x) x is the area under a central-t curve to the left of x and df,λ is the area to the left of x under a noncentral-t curve with degrees of freedom df and noncentrality parameter λ. Standard Deviations Unequal This case often recommends Welch s test. When σ σ, the power is calculated as follows. σ σ. Calculate: σ +.. Calculate: f x 4 σ x - σ 4 ( +) + σ 4 ( +) which is the adjusted degrees of freedom. Often, this is rounded to the next highest integer. ote that this is not the value of f used in the computation of the actual test. Instead, this is the expected value of f. 3. Find t α such that Tf ( tα ) α, where Tf ( tα ) degrees of freedom. ε 4. Calculate: λ, the noncentrality parameter. σ x 5. Calculate: Power Tf,λ ( tα ) ( ), where T x degrees of freedom f and noncentrality parameter λ. is the area to the left of x under a central-t curve with f f,λ is the area to the left of x under a noncentral-t curve with onparametric Adjustment When using the Mann-Whitney test rather than the t test, results by Al-Sunduqchi and Guenther (990) indicate that power calculations for the Mann-Whitney test may be made using the standard t test formulations with a simple adjustment to the sample sizes. The size of the adjustment depends on the actual distribution of the data. They give sample size adjustment factors for four distributions. These are for uniform, /3 for double exponential, 9 / π for logistic, and π / 3 for normal distributions

7 Logistic Make the Mann-Whitney sample size adjustment assuming that the data actually follow the logistic distribution. ormal Make the Mann-Whitney sample size adjustment assuming that the data actually follow the normal distribution. Power and Alpha Power This option specifies one or more values for power. Power is the probability of rejecting a false null hypothesis, and is equal to one minus Beta. Beta is the probability of a type-ii error, which occurs when a false null hypothesis is not rejected. In this procedure, a type-ii error occurs when you fail to reject the null hypothesis of inferiority when the null hypothesis should be rejected. Values must be between zero and one. Historically, the value of 0.80 (Beta 0.0) was used for power. ow, 0.90 (Beta 0.0) is also commonly used. A single value may be entered here or a range of values such as 0.8 to 0.95 by 0.05 may be entered. Alpha This option specifies one or more values for the probability of a type-i error. A type-i error occurs when a true null hypothesis is rejected. In this procedure, a type-i error occurs when you reject the null hypothesis of inferiority when in fact the mean is not non-inferior. Values must be between zero and one. Historically, the value of 0.05 has been used for alpha. This means that about one test in twenty will falsely reject the null hypothesis. You should pick a value for alpha that represents the risk of a type-i error you are willing to take in your experimental situation. You may enter a range of values such as or 0.0 to 0.0 by 0.0. Sample Size (When Solving for Sample Size) Group Allocation Select the option that describes the constraints on or or both. The options are Equal ( ) This selection is used when you wish to have equal sample sizes in each group. Since you are solving for both sample sizes at once, no additional sample size parameters need to be entered. Enter, solve for Select this option when you wish to fix at some value (or values), and then solve only for. Please note that for some values of, there may not be a value of that is large enough to obtain the desired power. Enter R /, solve for and For this choice, you set a value for the ratio of to, and then PASS determines the needed and, with this ratio, to obtain the desired power. An equivalent representation of the ratio, R, is R *

8 Enter percentage in Group, solve for and For this choice, you set a value for the percentage of the total sample size that is in Group, and then PASS determines the needed and with this percentage to obtain the desired power. (Sample Size, Group ) This option is displayed if Group Allocation Enter, solve for is the number of items or individuals sampled from the Group population. must be. You can enter a single value or a series of values. R (Group Sample Size Ratio) This option is displayed only if Group Allocation Enter R /, solve for and. R is the ratio of to. That is, R /. Use this value to fix the ratio of to while solving for and. Only sample size combinations with this ratio are considered. is related to by the formula: where the value [Y] is the next integer Y. [R ], For example, setting R.0 results in a Group sample size that is double the sample size in Group (e.g., 0 and 0, or 50 and 00). R must be greater than 0. If R <, then will be less than ; if R >, then will be greater than. You can enter a single or a series of values. Percent in Group This option is displayed only if Group Allocation Enter percentage in Group, solve for and. Use this value to fix the percentage of the total sample size allocated to Group while solving for and. Only sample size combinations with this Group percentage are considered. Small variations from the specified percentage may occur due to the discrete nature of sample sizes. The Percent in Group must be greater than 0 and less than 00. You can enter a single or a series of values. Sample Size (When ot Solving for Sample Size) Group Allocation Select the option that describes how individuals in the study will be allocated to Group and to Group. The options are Equal ( ) This selection is used when you wish to have equal sample sizes in each group. A single per group sample size will be entered. Enter and individually This choice permits you to enter different values for and. Enter and R, where R * Choose this option to specify a value (or values) for, and obtain as a ratio (multiple) of

9 Enter total sample size and percentage in Group Choose this option to specify a value (or values) for the total sample size (), obtain as a percentage of, and then as -. Sample Size Per Group This option is displayed only if Group Allocation Equal ( ). The Sample Size Per Group is the number of items or individuals sampled from each of the Group and Group populations. Since the sample sizes are the same in each group, this value is the value for, and also the value for. The Sample Size Per Group must be. You can enter a single value or a series of values. (Sample Size, Group ) This option is displayed if Group Allocation Enter and individually or Enter and R, where R *. is the number of items or individuals sampled from the Group population. must be. You can enter a single value or a series of values. (Sample Size, Group ) This option is displayed only if Group Allocation Enter and individually. is the number of items or individuals sampled from the Group population. must be. You can enter a single value or a series of values. R (Group Sample Size Ratio) This option is displayed only if Group Allocation Enter and R, where R *. R is the ratio of to. That is, R / Use this value to obtain as a multiple (or proportion) of. is calculated from using the formula: where the value [Y] is the next integer Y. [R x ], For example, setting R.0 results in a Group sample size that is double the sample size in Group. R must be greater than 0. If R <, then will be less than ; if R >, then will be greater than. You can enter a single value or a series of values. Total Sample Size () This option is displayed only if Group Allocation Enter total sample size and percentage in Group. This is the total sample size, or the sum of the two group sample sizes. This value, along with the percentage of the total sample size in Group, implicitly defines and. The total sample size must be greater than one, but practically, must be greater than 3, since each group sample size needs to be at least. You can enter a single value or a series of values

10 Percent in Group This option is displayed only if Group Allocation Enter total sample size and percentage in Group. This value fixes the percentage of the total sample size allocated to Group. Small variations from the specified percentage may occur due to the discrete nature of sample sizes. The Percent in Group must be greater than 0 and less than 00. You can enter a single value or a series of values. Effect Size Mean Difference IM (on-inferiority Margin) This is the magnitude of the margin of non-inferiority. It must be entered as a positive number. When higher means are better, this value is the distance below the reference mean that is still considered noninferior. When higher means are worse, this value is the distance above the reference mean that is still considered non-inferior. D (True Difference) This is the actual difference between the treatment mean and the reference mean at which power is calculated. For non-inferiority tests, this value is often set to zero. When this value is non-zero, care should be taken that this value is consistent with whether higher means are better or worse. Effect Size Standard Deviations S and S (Standard Deviations) These options specify the values of the standard deviations for each group. When the S is set to S, the EQUAL VARIACE test is used and only S needs to be specified. The value of S will be used for S. Otherwise, the UEQUAL VARIACE test is used (even if the value entered for S equals S). When these values are not known, you must supply estimates of them. Press the SD button to display the Standard Deviation Estimator window. This procedure will help you find appropriate values for the standard deviation

11 Example Power Analysis Suppose that a test is to be conducted to determine if a new cancer treatment adversely affects bone density. The adjusted mean bone density (AMBD) in the population of interest is gm/cm with a standard deviation of gm/cm. Clinicians decide that if the treatment reduces AMBD by more than 5% ( gm/cm), it poses a significant health threat. They also want to consider what would happen if the margin of equivalence is set to.5% ( gm/cm). Following accepted procedure, the analysis will be a non-inferiority test using the t-test at the 0.05 significance level. Power to be calculated assuming that the new treatment has no effect on AMBD. Several sample sizes between 0 and 800 will be analyzed. The researchers want to achieve a power of at least 90%. All numbers have been multiplied by 0000 to make the reports and plots easier to read. Setup This section presents the values of each of the parameters needed to run this example. First, from the PASS Home window, load the procedure window by expanding Means, then Two Independent Means, then clicking on on-inferiority, and then clicking on on-inferiority Tests for Two Means using Differences. You may then make the appropriate entries as listed below, or open Example by going to the File menu and choosing Open Example Template. Option Value Design Tab Solve For... Power Higher Means Are... Better onparametric Adjustment... Ignore Alpha Group Allocation... Equal ( ) Sample Size Per Group IM (on-inferiority Margin) D (True Difference)... 0 S (Standard Deviation Group )... 3 S (Standard Deviation Group )... S Annotated Output Click the Calculate button to perform the calculations and generate the following output. umeric Results and Plots umeric Results for on-inferiority Test (H0: Diff -IM; H: Diff > -IM) Higher Means are Better Test Statistic: T-Test Power -IM D S S Alpha (report continues) 450-

12 References Chow, S.C.; Shao, J.; Wang, H Sample Size Calculations in Clinical Research. Marcel Dekker. ew York. Julious, Steven A 'Tutorial in Biostatistics. Sample sizes for clinical trials with ormal data.' Statistics in Medicine, 3: Report Definitions Power is the probability of rejecting a false null hypothesis. and are the number of items sampled from each population. is the total sample size, +. -IM is the magnitude and direction of the margin of non-inferiority. Since higher means are better, this value is negative and is the distance below the reference mean that is still considered non-inferior. D is the mean difference at which the power is computed. D Mean - Mean, or Treatment Mean - Reference Mean. S and S are the assumed population standard deviations for groups and, respectively. Alpha is the probability of rejecting a true null hypothesis. Summary Statements Group sample sizes of 0 and 0 achieve 6% power to detect non-inferiority using a one-sided, two-sample t-test. The margin of equivalence is The true difference between the means is assumed to be The significance level (alpha) of the test is The data are drawn from populations with standard deviations of and Chart Section 450-

13 The above report shows that for IM.5, the sample size necessary to obtain 90% power is about 50 per group. However, if IM 0.575, the required sample size is about 600 per group

14 Example Finding the Sample Size Continuing with Example, the researchers want to know the exact sample size for each value of IM to achieve 90% power. Setup This section presents the values of each of the parameters needed to run this example. First, from the PASS Home window, load the procedure window by expanding Means, then Two Independent Means, then clicking on on-inferiority, and then clicking on on-inferiority Tests for Two Means using Differences. You may then make the appropriate entries as listed below, or open Example by going to the File menu and choosing Open Example Template. Option Value Design Tab Solve For... Sample Size Higher Means Are... Better onparametric Adjustment... Ignore Power Alpha Group Allocation... Equal ( ) IM (on-inferiority Margin) D (True Difference)... 0 S (Standard Deviation Group )... 3 S (Standard Deviation Group )... S Output Click the Calculate button to perform the calculations and generate the following output. umeric Results umeric Results for on-inferiority Test (H0: Diff -IM; H: Diff > -IM) Higher Means are Better Test Statistic: T-Test Target Actual Power Power -IM D S S Alpha This report shows the exact sample size requirement for each value of IM

15 Example 3 Validation using Chow Chow, Shao, Wang (003) page 6 has an example of a sample size calculation for a non-inferiority trial. Their example obtains a sample size of 5 in each group when D 0, IM 0.05, S 0., Alpha 0.05, and Beta 0.0. Setup This section presents the values of each of the parameters needed to run this example. First, from the PASS Home window, load the procedure window by expanding Means, then Two Independent Means, then clicking on on-inferiority, and then clicking on on-inferiority Tests for Two Means using Differences. You may then make the appropriate entries as listed below, or open Example 3 by going to the File menu and choosing Open Example Template. Option Value Design Tab Solve For... Sample Size Higher Means Are... Better onparametric Adjustment... Ignore Power Alpha Group Allocation... Equal ( ) IM (on-inferiority Margin) D (True Difference)... 0 S (Standard Deviation Group ) S (Standard Deviation Group )... S Output Click the Calculate button to perform the calculations and generate the following output. umeric Results umeric Results for on-inferiority Test (H0: Diff -IM; H: Diff > -IM) Higher Means are Better Test Statistic: T-Test Target Actual Power Power -IM D S S Alpha PASS also obtains a sample size of 5 per group

16 Example 4 Validation using Julious Julious (004) page 950 gives an example of a sample size calculation for a parallel, non-inferiority design. His example obtains a sample size of 336 when D 0, IM 0, S 40, Alpha 0.05, and Beta 0.0. Setup This section presents the values of each of the parameters needed to run this example. First, from the PASS Home window, load the procedure window by expanding Means, then Two Independent Means, then clicking on on-inferiority, and then clicking on on-inferiority Tests for Two Means using Differences. You may then make the appropriate entries as listed below, or open Example 4 by going to the File menu and choosing Open Example Template. Option Value Design Tab Solve For... Sample Size Higher Means Are... Better onparametric Adjustment... Ignore Power Alpha Group Allocation... Equal ( ) IM (on-inferiority Margin)... 0 D (True Difference)... 0 S (Standard Deviation Group ) S (Standard Deviation Group )... S Output Click the Calculate button to perform the calculations and generate the following output. umeric Results umeric Results for on-inferiority Test (H0: Diff -IM; H: Diff > -IM) Higher Means are Better Test Statistic: T-Test Target Actual Power Power -IM D S S Alpha PASS obtained sample sizes of 337 in each group. The difference between 336 that Julious received and 337 that PASS calculated is likely caused by rounding

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