Declare a public trial design — pmx_trial

Every field is a design fact from the protocol and consumes no privacy budget. See the data elicitation guide at https://iamstein.github.io/synpmx/articles/data-elicitation.html for which parts of a realized design need a provenance note.

Usage

pmx_trial_design(
  dose_levels = NULL,
  cohort_sizes = NULL,
  sampling,
  n_doses = 1L,
  dose_interval = 24,
  dose_escalation = NULL,
  dose_times = NULL,
  duration = 0,
  visit_window = 0.05,
  source
)

Arguments

dose_levels: Dose amounts, one per cohort. Omit when using dose_escalation.
cohort_sizes: Planned subjects per cohort, recycled over dose_levels. Defaults to equal cohorts.
sampling: Nominal sampling times after a dose, from the protocol, measured from that dose. A single numeric vector applies the same schedule after every dose. Real protocols often do not: to sample richly after some doses and sparsely or not at all after others, supply a list with one element per dose, using NULL for a dose with no samples. A seven-dose study with full profiles on the first and last days and a single trough in between is sampling = list(rich, 0, NULL, NULL, NULL, 0, rich).
n_doses: Number of doses per subject in a parallel design.
dose_interval: Time between doses when doses are equally spaced.
dose_escalation: Per-occasion dose amounts for a within-subject escalation, for example c(10, 30, 100). Applied to every subject. For a trial that also escalates between cohorts, supply a list of sequences, one per cohort, for example list(c(1, 2, 4), c(2, 4, 8), c(4, 8, 16)), with cohort_sizes giving the subjects in each. Every sequence must have the same length, since the dosing schedule is shared.
dose_times: Explicit dose times, for example c(0, 7, 14). Defaults to equally spaced times at dose_interval.
duration: Infusion duration; zero for bolus or oral.
visit_window: Fractional jitter applied to nominal times.
source: Required provenance string.

Value

A pmx_trial_design.

Details

Two dosing patterns are supported. A parallel design gives each cohort one dose level (dose_levels) repeated n_doses times. A within-subject escalation gives every subject the same increasing sequence of doses (dose_escalation), one per occasion; this is prespecified design, not an outcome, when the escalation follows a fixed protocol schedule.