List of the trial design and other parameters. The required elements are defined below:
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endpoint_type: Character value defining the common type of trial endpoints. Possible values:
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direction: Character value defining the common direction of favorable outcome for all endpoints. Possible values: "Higher" (a higher value of each endpoint indicates a more favorable outcome) and "Lower" (a lower value of each endpoint indicates a more favorable outcome).
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n_comparisons: Integer value defining the number of dose-control comparisons in the trial. This value must be positive.
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n_endpoints: Integer value defining the number of endpoints in the trial. This value must be positive. Either n_comparisons or n_endpoints must be greater than 1.
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sample_size: Integer vector defining the number of enrolled patients in each trial arm (control and experimental treatments). Each element must be positive.
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control_mean: Numeric vector defining the mean of each endpoint in the control arm. This parameter is required only with normally distributed endpoints (endpoint_type="Normal").
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control_sd: Numeric vector defining the standard deviation of each endpoint in the control arm. Each element must be positive. This parameter is required only with normally distributed endpoints.
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treatment_mean: Numeric vector or matrix defining the mean of each endpoint in each experimental treatment arm. In clinical trials with several endpoints and several dose-placebo comparisons, the rows corresponds to the endpoints and the columns corresponds to the treatment-control comparisons. This parameter is required only with normally distributed endpoints.
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treatment_sd: Numeric vector or matrix defining the standard deviation of each endpoint in each experimental treatment arm. In clinical trials with several endpoints and several dose-placebo comparisons, the rows corresponds to the endpoints and the columns corresponds to the treatment-control comparisons. Each element must be positive. This parameter is required only with normally distributed endpoints.
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control_rate: Numeric vector defining the proportion or response rate for each endpoint in the control arm. Each element must be between 0 and 1. This parameter is required only with binary endpoints (endpoint_type= "Binary").
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treatment_rate: Numeric vector or matrix defining the proportion or response rate for each endpoint in each experimental treatment arm. In clinical trials with several endpoints and several dose-placebo comparisons, the rows corresponds to the endpoints and the columns corresponds to the treatment-control comparisons. Each element must be between 0 and 1. This parameter is required only with binary endpoints.
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endpoint_correlation: Numeric matrix defining the pairwise correlations among the endpoint-specific test statistics. Each element must be between 0 and 1 and the matrix must be positive definite. This parameter is required only in trials with multiple endpoints.
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mult_test: Character value defining the multiple testing procedure, global testing procedure or gatekeeping procedure. Possible values:
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"Bonferroni": Bonferroni multiple testing procedure.
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"Holm": Holm multiple testing procedure in trials with a single source of multiplicity or Holm-based gatekeeping procedure in trials with several sources of multiplicity.
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"Fixed-sequence": Fixed-sequence multiple testing procedure.
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"Chain": Chain multiple testing procedure.
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"Hochberg": Hochberg multiple testing procedure in trials with a single source of multiplicity or Hochberg-based gatekeeping procedure in trials with several sources of multiplicity.
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"Hommel": Hommel multiple testing procedure in trials with a single source of multiplicity or Hommel-based gatekeeping procedure in trials with several sources of multiplicity.
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"O'Brien": O'Brien global testing procedure.
Note that the O'Brien procedure can be used only in two-arm trials with several endpoints, similarly gatekeeping procedures can be used only in trials with several endpoints and several dose-placebo comparisons.
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weights: Numeric vector defining the initial hypothesis weights. Each element must be between 0 and 1. This parameter is required only with multiple testing procedures.
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transition: Numeric matrix defining the hypothesis transition parameters. Each element must be between 0 and 1 and the sum of elements in each row must be less than or equal to 1. This parameter is required only with the chain multiple testing procedure.
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sequence: Integer vector defining the hypothesis testing sequence. This parameter is required only with the fixed-sequence multiple testing procedures.
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mult_method: Character value defining the mixture method for the gatekeeping procedure. Possible values:
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"Standard": Standard mixture method.
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"Modified": Modified mixture method.
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"Enhanced": Enhanced mixture method.
This parameter is required only with gatekeeping procedures.
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mult_test_gamma: Numeric vector defining the truncation parameter for each endpoint-specific family of hypotheses. The vector's length must be equal to the number of endpoints. Each element must be between 0 and 1, the last element may be equal to 1 whereas the other elements must be strictly less than 1. This parameter is required only with gatekeeping procedures.
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dropout_rate: Numeric value defining the patient dropout rate. A uniform patient dropout process is assumed and thus this parameter defines the fraction of patients that will be excluded from the analysis. This value must be between 0 and 1.
alpha: Numeric value defining the overall one-sided Type I error rate. The default value is 0.025.
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random_seed: Integer value defining the random number generator seed. The default value is 49283.
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nsims: Integer value defining the number of simulation runs.
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ncores: Integer value defining the number of cores for parallel calculations. The number of cores cannot exceed the maximum available number of cores. The default value is 1.