R: Required Responders for GO decision Single Arm

req_resp {earlygating}

R Documentation

Required Responders for GO decision Single Arm

Description

Function for calculating the minimum required number of responders in the experimental group to make a GO decision in Settings 1 and 2.

Usage

req_resp(
  N_e,
  delta,
  confidence,
  e_a = 0.5,
  e_b = 0.5,
  h_a = 0.5,
  h_b = 0.5,
  RR_h = NULL,
  N_h = NULL,
  hist_RR_c = NULL,
  adapt = 1
)

Arguments

`N_e`	Sample Size in the experimental group.
`delta`	Required superiority to make a "GO" decision. Corresponds to `\delta`.
`confidence`	Required confidence to make "GO" decision. Corresponds to `\gamma`.
`e_a`	Alpha parameter of Beta Prior Distribution for the experimental response rate. Corresponds to `\alpha_e`. Default is `\frac{1}{2}`.
`e_b`	Beta parameter of Beta Prior Distribution for the experimental response rate. Corresponds to `\beta_e`. Default is `\frac{1}{2}`.
`h_a`	Alpha parameter of Beta Prior Distribution for the historical control response rate. Corresponds to `\alpha_h`. Only needs to be specified, if RR_h and N_h are also specified. Default is `\frac{1}{2}`.
`h_b`	Beta parameter of Beta Prior Distribution for the historical control response rate. Corresponds to `\beta_h`. Only needs to be specified, if RR_h and N_h are also specified. Default is `\frac{1}{2}`.
`RR_h`	Historical control response rate. Corresponds to `p_h`. If specified together with N_h, function will use setting 2 from pdf.
`N_h`	Historical control sample size. Corresponds to `n_h`. If specified together with RR_h, function will use setting 2 from pdf.
`hist_RR_c`	Point estimate of historical control repsonse rate. Corresponds to `\hat{p_h}`. If specified, while RR_h and N_h are not specified, function will use setting 1 from pdf.
`adapt`	Level of adapting of experimental control rate to account for patient selection bias from phase II to phase III. Corresponds to `\xi`. Default is 1, so no adapting.

Value

Integer.

Examples


# Setting 1
req_resp(
  N_e = 50, delta = 0.08,
  confidence = 0.6, hist_RR_c = 0.5
)

# Setting 2
req_resp(
  N_e = 50, delta = 0.08,
  confidence = 0.6, RR_h = 0.5, N_h = 50
)

[Package earlygating version 1.1 Index]