Design and Simulation of Seamless Phase II-III Clinical Trials


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Documentation for package ‘sp23design’ version 0.9-1

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sp23design-package sp23design: A package for the design, exploration and execution of seamless Phase II-II clinical trials
analyzeSP23Design Analyses the results of running a design. If a trial history, such as the result of the function 'executeSP23Design' or a history of the actual conduct of a single trial is provided, it returns the analysis results.
computeDGivenXi Given the estimates of the pi and theta, compute d.
computeGammaSubT Compute the estimate of the variance of the generalized likelihood ratio statistic at time t
computeResponseSummary Given interim data, compute the response end-point summary
executeSP23Design Given a design object, interim data and the current calendar time, conduct the interim analysis for the time
exploreSP23Design Explore a specified design by simulation
generateClinicalTrialData A function to generate some clinical trial data according the joint model of response and survival for simulations
generateInterimData Generate interim data for a clinical trial from a data set.
generateSP23Design Generate a seamless Phase II-III design object given some the true parameters and clinical trial parameters
hessian A utility function to compute the hessian of the generalized (conditional) partial likelihood ratio statistic
loglik1 Compute the response log-likelihood
loglik1GivenDelta Computes the constrained response log-likelihood (on the alternative)
loglik2 Computes the survival log-likelihood
loglik2.repar0 Computes the constrained survival log-likelihood
mHP.b Compute the modified Haybittle-Peto boundary
mHP.c Compute the modified Haybittle-Peto boundary for the final look
performInterimLook Perform an interim look in a seamless Phase II-III clinical trial
resetSP23Design Reset the design object so that counts and results are zeroed out
solveForCGivenABD A convenience function to reduce dimension by solving for one variable c in terms of others a, b, d
sp23design sp23design: A package for the design, exploration and execution of seamless Phase II-II clinical trials