R/curtail.R

#' @title Design of One- and Two-Stage Clinical Trials with Curtailed Sampling
#' @name curtail
#' @docType package
#' @description The \pkg{curtail} package is used for the planning of one- 
#' and two- stage clinical trials with curtailed sampling. Under curtailed 
#' sampling, an early decision in the trial is allowed as soon as any 
#' predefined statistical endpoint is reached. The package provides functions 
#' to help select a design, including visualizations to compare criteria for 
#' different choices of parameters, and functions to calculate power, 
#' significance, and expected sample size, among others.
#' 
#' In the one-stage design, patients are assumed to be enrolled into the trial 
#' sequentially up to a maximum number of patients. A critical value of 
#' observed patient successes needed to deem the therapy superior is set prior 
#' to the start of the study. The \code{power_significance_plot} and 
#' \code{power_significance_ROC} functions provide visualizations to compare 
#' power and significance levels for various choices of critical values. Also, 
#' the \code{critical_values} function will calculate the critical value to 
#' maintain a desired significance level.  Under curtailed sampling, the study 
#' ends as soon as enough the observed patient successes meets the critical 
#' value or as soon as too many patient failures have been observed. The 
#' smallest number of patient enrollees needed to reach a decision under 
#' curtailed sampling is described by the Stopped Negative Binomial 
#' distribution. This package also provides density and other related 
#' functions for the Stopped Negative Binomial Distribution. 
#' 
#' The two-stage design presented in this package is a modification of Simon's 
#' two-stage design with separate, but nested, criteria for early stopping in 
#' Stage 1 and efficacy in Stage 2. The two-stage design has two critical 
#' values which can both be determined with the \code{critical_values} 
#' function to maintain a desired significance level and probability of early 
#' stopping. These critical values are set prior to the start of the study to 
#' determine the number of patient successes in the first stage needed to 
#' continue the trial to the second stage and the critical number of efficacy 
#' successes throughout the trial needed to deem the therapy superior. Under 
#' curtailed sampling, early decisions can be made in Stage 1 and Stage 2. 
#' The \code{best_designs} function finds the optimal and minimax design 
#' for a fixed total sample size. Other functions are provided to calculate the 
#' expected sample size, power, significance, and probability of early 
#' stopping in the trial given a choice of design parameters.
#' 
#' 
#' One-Stage Design Function Calls
#' \itemize{
#' \item{critical_values: }{finds the minimum number of successes to reject the null 
#' hypothesis with significance level alpha}
#' \item{single_stage_significance: }{computes the probability of rejecting the null 
#' hypothesis assuming the null probability of success}
#' \item{single_stage_power: }{computes the probability of rejecting the null 
#' hypothesis assuming an alternative probability of success}
#' \item{single_stage_expected_sample_size: }{computes the mean and standard deviation of 
#' the sample size for the one-stage design}
#' \item{zplot: }{visualize the Stopped Negative Binomial process with horizontal 
#' axis counting patient successes and vertical axis counting patient failures}
#' \item{kplot: }{visualize the Stopped Negative Binomial process with horizontal 
#' axis counting patients enrolled and vertical axis counting the number of 
#' successes}
#' \item{power_significance_plot: }{Plot power and significance across all trial 
#' designs with a fixed maximum number of patients}
#' \item{power_significance_ROC: }{ROC curve of Power vs. 1-Significance for all 
#' trial designs with a fixed number of maximum patients}
#' }
#' 
#' #' Stopped Negative Binomial Distribution Function Calls
#' \itemize{
#' \item{dsnb: }{density for the Stopped Negative Binomial Distribution}
#' \item{psnb: }{distribution function for the Stopped Negative Binomial Distribution}
#' \item{qsnb: }{quantile function for the Stopped Negative Binomial Distribution}
#' \item{rsnb: }{randomly generated value from the Stopped Negative Binomial 
#' distribution}
#' \item{esnb: }{expected value of the Stopped Negative Binomial distribution}
#' \item{vsnb: }{variance of the Stopped Negative Binomial distribution}
#' \item{dsnb_stacked: }{computes the density stacked by responders and non-
#' responders}
#' \item{stacked_plot: }{stacked plot of the probability mass function for the snb showing
#' the contributions from N (the top barrier) and R (the right barrier)}
#' \item{dsnb_plot: }{plot of the probability mass function for the Stopped Negative Binomial}
#' \item{dsnb_stack_plot: }{The stacked plot of the probability mass function for the SNB 
#' showing the contributions from N (the top barrier) and R (the right barrier) by color.}
#' }
#' 
#' Two-Stage Design Function Calls
#' \itemize{
#' \item{critical_values: }{finds the critical values the number of Stage 1 successes to continue to
#' Stage 2 and the minimum number of Stage 2 successes to the reject the null hypothesis}
#' \item{prob_early_stop: }{computes the probability of stopping the trial after Stage 1}
#' \item{expected_stage1_sample_size: }{computes the expected sample size and standard deviation for Stage 1 
#' of the two-stage design under curtailed sampling}
#' \item{expected_total_sample_size: }{computes the expected number of patients who are 
#' enrolled and followed to their endpoint before critical endpoints in Stage 1 and Stage 2 
#' are achieved}
#' \item{all_minimax_designs: }{computes the minimax probability for each possible design for a 
#' a given total n}
#' \item{all_optimal_designs: }{computes the expected curtailed sample size for each possible design for a 
#' a given total n}
#' \item{best_designs: }{finds the minimax and optimal designs for a given total n}
#' \item{plot.ph2_design: }{plots the optimal and minimax criteria for each possible
#' design over different values of n1}
#' \item{minimax_design: }{computes the minimax probability for a given design with 
#' specified n1 and n2}
#' }
#' 
#' Acknowledgements: This work was partially supported through a 
#' Patient-Centered Outcomes Research Institute (PCORI) Award (ME-1511-32832).
#'
#' Disclaimer: All statements in this report, including its findings and 
#' conclusions, are solely those of the authors and do not necessarily 
#' represent the views of the Patient-Centered Outcomes Research Institute 
#' (PCORI), its Board of Governors or Methodology Committee.
#' 
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kaneplusplus/curtail documentation built on May 24, 2019, 2:04 a.m.