# Adaptive designs with response-adaptive randomization (Case study F1) # Visit MedianaDesigner's online manual (https://medianasoft.github.io/MedianaDesigner) for more case studies library(MedianaDesigner) ##################################### # List of all parameters parameters = list() # Endpoint type parameters$endpoint_type = "Normal" # Direction of favorable outcome parameters$direction = "Lower" # Dose levels in the trial parameters$dose_levels = c(0, 100, 200, 400, 800) # Mean and SD in the control arm parameters$control_mean = -10 parameters$control_sd = 14 # Mean and SD in the treatment arms parameters$treatment_mean = c(-12, -14, -16, -18) parameters$treatment_sd = c(14, 14, 14, 14) # Total number of enrolled patients in each trial stage parameters$stage_sample_size = c(50, 50, 50, 50) # Length of the patient enrollment period parameters$enrollment_period = 36 # Median enrollment time, i.e., the time point by which 50% of the patients will be enrolled into the trial parameters$enrollment_parameter = 24 # Length of the treatment period parameters$treatment_period = 4 # Fixed randomization ratio in the placebo arm parameters$ratio_placebo = 0.2 # Patient dropout rate parameters$dropout_rate = 0.05 # Clinically relevant improvement over placebo parameters$delta = -6 # Balance parameter for adaptive randomization parameters$balance = 2 # Non-linear parameters of the candidate dose-response models used in the MCPMod method # Non-linear parameter of the exponential model (delta) parameters$exponential_model_parameter = 400 # Non-linear parameter of the Emax model (ED50) parameters$emax_model_parameter = 600 # Non-linear parameter of the logistic model (ED50 and delta) parameters$logistic_model_parameters = c(400, 50) # One-sided Type I error rate parameters$alpha = 0.025 # Number of simulations parameters$nsims = 1000 ##################################### # Run simulations results = ADRand(parameters) ##################################### # Create a simulation report GenerateReport(results, "CaseStudyF1.docx")