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sp23design (version 0.9-1)

Design and Simulation of Seamless Phase II-III Clinical Trials

Description

Provides methods for generating, exploring and executing seamless Phase II-III designs of Lai, Lavori and Shih using generalized likelihood ratio statistics. Includes pdf and source files that describe the entire R implementation with the relevant mathematical details.

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Install

install.packages('sp23design')

Monthly Downloads

164

Version

0.9-1

License

LGPL-3

Maintainer

Balasubramanian Narasimhan

Last Published

April 19th, 2022

Functions in sp23design (0.9-1)

generateClinicalTrialData

A function to generate some clinical trial data according the joint model of response and survival for simulations
resetSP23Design

Reset the design object so that counts and results are zeroed out
performInterimLook

Perform an interim look in a seamless Phase II-III clinical trial
hessian

A utility function to compute the hessian of the generalized (conditional) partial likelihood ratio statistic
executeSP23Design

Given a design object, interim data and the current calendar time, conduct the interim analysis for the time
generateSP23Design

Generate a seamless Phase II-III design object given some the true parameters and clinical trial parameters
computeResponseSummary

Given interim data, compute the response end-point summary
computeGammaSubT

Compute the estimate of the variance of the generalized likelihood ratio statistic at time \(t\)
mHP.b

Compute the modified Haybittle-Peto boundary
mHP.c

Compute the modified Haybittle-Peto boundary for the final look
sp23design-package

sp23design: A package for the design, exploration and execution of seamless Phase II-II clinical trials
loglik1GivenDelta

Computes the constrained response log-likelihood (on the alternative)
exploreSP23Design

Explore a specified design by simulation
solveForCGivenABD

A convenience function to reduce dimension by solving for one variable \(c\) in terms of others \(a\), \(b\), \(d\)
loglik1

Compute the response log-likelihood
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 \(d\).
loglik2

Computes the survival log-likelihood
loglik2.repar0

Computes the constrained survival log-likelihood
generateInterimData

Generate interim data for a clinical trial from a data set.