In mjg211/multiarm: Design of single- and multi-stage multi-arm clinical trials

```r knitr::opts_chunk$set(echo = F, results = "asis")

```r
alpha      <- params$alpha
beta       <- params$beta
delta0     <- params$delta0
delta1     <- params$delta1
e          <- params$e
efix       <- params$efix
f          <- params$f
ffix       <- params$ffix
integer    <- params$integer
J          <- params$J
K          <- params$K
lower      <- params$lower
maxN       <- params$maxN
n10        <- params$n10
n1         <- params$n1
opchar     <- params$opchar
pi0        <- params$pi0
plots      <- params$plots
power      <- params$power
ratio_type <- params$ratio_type
ratio_init <- params$ratio_init
ratio      <- params$ratio
sigma      <- params$sigma
stopping   <- params$stopping
swss       <- params$swss
upper      <- params$upper

if (power == "marginal") {
  power_type_text     <- "marginal power for each null hypothesis"
  power_scenario_text <-
    "each of their respective least favourable configurations"
} else {
  power_scenario_text <- "the global alternative hypothesis"
  if (power == "conjunctive") {
    power_type_text   <- "conjunctive power"
  } else if (power == "disjunctive") {
    power_type_text   <- "disjunctive power"
  }
}

if (ratio_type == "equal_all") {
  ratio_text          <- "the same as the control arm"
} else if (ratio_type == "equal_exp") {
  ratio_text          <- paste0(ratio_init[1], " times that of the control arm")
} else {
  ratio_text          <- paste0(round(1/sqrt(K), 3),
                                " times that of the control arm")
}

if (lower == "fixed") {
  lower_prelim <- "fixed value"
} else if (lower == "obf") {
  lower_prelim <- "O'Brien-Fleming"
} else if (lower == "pocock") {
  lower_prelim <- "Pocock"
} else if (lower == "triangular") {
  lower_prelim <- "triangular"
}

if (upper == "fixed") {
  upper_prelim <- "fixed value"
} else if (upper == "obf") {
  upper_prelim <- "O'Brien-Fleming"
} else if (upper == "pocock") {
  upper_prelim <- "Pocock"
} else if (upper == "triangular") {
  upper_prelim <- "triangular"
}

if (lower == "fixed") {
  lower_text          <- paste0(lower_prelim, ", with a fixed value of ", ffix)
} else {
  lower_text          <- lower_prelim
}

if (upper == "fixed") {
  upper_text          <- paste0(upper_prelim, ", with a fixed value of ", efix)
} else {
  upper_text          <- upper_prelim
}

if (integer) {
  integer_text        <- "will"
} else {
  integer_text        <- "will not"
}

if (plots) {
  plot_text           <- "will"
} else {
  plot_text           <- "will not"
}

FWER                  <- round(opchar$FWERI1[1], 3)
if (power == "marginal") {
  power_type_text     <- "minimum marginal power"
  power_value         <-
    round(min(diag(as.matrix(opchar[-(1:2), (K + 4):(2*K + 3)]))), 3)
} else {
  power_scenario_text <- "the global alternative hypothesis."
  if (power == "conjunctive") {
    power_type_text   <- "conjunctive power"
    power_value       <- round(opchar$Pcon[2], 3)
  } else if (power == "disjunctive") {
    power_type_text   <- "disjunctive power"
    power_value       <- round(opchar$Pdis[2], 3)
  }
}
if (swss == "fixed") {
  swss_text  <- "is"
  swss_text2 <- round(n1, 3)
} else {
  swss_text  <- "to the control arm is"
  swss_text2 <- round(n10, 3)
}

Inputs

The following choices were made:

• $K = \boldsymbol{r K}$ experimental treatments will initially be included in the trial.
• A maximum of $J = \boldsymbol{r J}$ stages will be allowed in the trial.
• A r stopping stopping rule will be used.
• The stage-wise sample size will be r swss.
• The lower stopping boundaries will be r lower_text.
• The upper stopping boundaries will be r upper_text.
• A family-wise error-rate of $\alpha = \boldsymbol{r alpha}$ will be used.
• The r power_type_text will be controlled to level $1-\beta = \boldsymbol{r 1 - beta}$ under r power_scenario_text.
• The response rate in the control arm will be assumed to be: $\pi_0 = \boldsymbol{r pi0}$.
• The interesting and uninteresting treatment effects will be: $\delta_1 = \boldsymbol{r round(delta1, 3)}$ and $\delta_0 = \boldsymbol{r round(delta0, 3)}$ respectively.
• The target allocation to each of the experimental arms will be: r ratio_text.
• The sample size in each arm r integer_text be required to be an integer.
• Plots r plot_text be produced.

Outputs

• The maximum required sample size is: $\boldsymbol{r round(maxN, 3)}$.
• The stage-wise sample size r swss_text: r swss_text2.
• The realised allocation ratios to the experimental arms are: $(r_1,\dots,r_K) = \boldsymbol{(r paste(rep(round(ratio, 3), K), collapse = ", "))}$.
• The maximum familywise error-rate is: $\boldsymbol{r FWER}$.
• The r power_type_text is: $\boldsymbol{r power_value}$.
• The lower stopping boundaries are: $\boldsymbol{r paste0("(", paste(round(f, 3), collapse = ", "), ")")}$.
• The upper stopping boundaries are: $\boldsymbol{r paste0("(", paste(round(e, 3), collapse = ", "), ")")}$.

mjg211/multiarm documentation built on Jan. 19, 2024, 8:21 a.m.