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Results from 1.2.0 are not reproduced exactly: the event-cut convention (below) and the exponential predictive simulation changed.
cens_data(cens_method = "Events", cens_events = k) is now
the only routine that cuts a trial at an analysis (used by
apply_GSD_to_trial(), single_grid_rep() and
the new paired runner). Cutting at k events leaves exactly
k events: previously the group-sequential code censored the
k-th event. Event counts at an information fraction are
floor(IF * total_events) (with a small tolerance),
replacing ceiling(); information fractions are rounded to 6
dp wherever they are compared.PP_func(): an exponential control arm now runs the
Weibull code path with gamma_c = 1. This fixes the
exponential branch for treated patients censored before the delay, where
one uniform draw both chose the branch and placed the event time, so the
late-branch time could fall below the delay. Weibull results are
unchanged.make_rpact_design_from_GSD_model(): for
"PP" and "MatchedZ" futility, the efficacy
critical values are taken from the efficacy-only design. A zero-alpha
futility look cannot change them, but rpact’s numerical integration
moved them by about 8e-5 when the futility look was close to an efficacy
look (e.g. 0.7 and 0.75).update_priors(): converged is now computed
over finite R-hat values only and is NA (not
TRUE) when none are finite.summarize_grid_by_kappa() and
select_kappa_star() are replaced. power_LCB is
now a one-sided 95% exact (Clopper-Pearson) lower bound (argument
lcb_level, replacing conf_level); new columns
n, n_NA_dropped, power_SE,
ESS_SE; replicates with NA PP_val
are dropped with a warning; exclude_nonconverged option.
select_kappa_star() accepts per-scenario floors, treats an
NA lower bound as infeasible, breaks ties in null ESS
towards the larger kappa, and reports power and floors in the
feasibility table.single_paired_rep() and
run_paired_scenario(): one simulated trial per replicate
with one PP evaluation, recording interim, efficacy-look and final
statistics (log-rank and modestly weighted log-rank) so that every
design (D1-D5) and kappa is a post hoc summary.
run_paired_scenario() runs in parallel chunks with an RDS
checkpoint and resumes from it.
compute_relative_floors(): D2 power minus a margin,
per alternative scenario, for use as power_floor.
update_priors(jags_seed = ) makes the MCMC
reproducible, and new attributes rhat_max,
n_nonfinite_rhat and
n_retained_total.
survival_test(return_HR = ): FALSE
skips the Cox fit (used by the PP and group-sequential code, where the
hazard ratio is not needed).
calc_dte_assurance_adaptive() returns
PP_val, P_Z1, P_Z2,
P_Z3 per trial and a settings attribute
(arguments, package and R versions, git commit if available,
timestamp).
Internal
simulate_trial_with_recruitment(force_state = ) fixes the
latent state, and the simulated data carry a truth
attribute.
inst/benchmark/time_one_rep.R (in the source
repository only) times one paired replicate at the manuscript
settings.
make_gsd_design() (exported; previously the internal
make_rpact_design_from_GSD_model(), kept as an alias for
one release) and apply_GSD_to_trial() are now exported and
documented.
apply_design_rule(): D1-D5 decisions post hoc from
run_paired_scenario() output, using the same decision
labels as apply_GSD_to_trial(). A test checks that both
give identical decisions, stop times and sample sizes on the same
simulated trials.
run_paired_scenario() is the single entry point for
the paper’s simulation tables.
settings returned by the simulation functions now
record all arguments plus the package, R, rjags and JAGS versions, the
git commit of the working directory, the hostname and a
timestamp.
run_test()) and one truth simulator
(simulate_trial_from_truth()) replace repeated code;
outputs are identical under a fixed seed.update_priors()
prior) instead of with nleqslv, which could fail silently.
Results agree to about 1e-8 relative; invalid landmarks (S(t2) <= 0
or S(t2) >= S(t1)) now give an informative error.
nleqslv moves from Imports to Suggests. The assurance Shiny
app uses the same closed form.survival_test(): alpha has no default (it
previously defaulted to 0.05; alpha = NULL returns
Signif = NA when only Z is needed), the
documented default alternative is now the actual default
("one.sided"), and Signif is always logical
(FALSE if Z is NA).apply_GSD_to_trial() and
calc_dte_assurance_adaptive() uses the specified test
statistic (analysis_model$method) and the design’s
boundaries, replacing a hard-coded Cox Wald statistic at a flat
qnorm(0.975); Success is derived only from
Decision."MatchedZ" futility looks are included in the design’s
information-rate grid with zero alpha spent.update_priors() monitors the latent state
Z and returns R-hat and state-probability diagnostics;
calibration output records them.nphRCT::wlrt() is negated so that
positive Z means benefit for all three methods.calibrate_PP_timing() defaults for
update_priors_sims and PP_sims are 1000 and
2000 (previously hard-coded to 100 and 50).PP_func() and
update_priors(), the legacy censoring_model
fallback of PP_func(),
calibrate_PP_threshold() (and its internal
single_calibration_rep()), and the internal
summarize_gsd_results() and
summarize_convergence().PP_func(): n_sims is required.calc_dte_assurance_adaptive():
update_priors_sims and PP_sims are required
when futility_type = "PP".recruitment_model$method = "power",
power = 1), the assumption under which
PP_func() draws future recruitment times.update_priors(): n_samples is per chain
(total n.chains * n_samples)."MatchedZ" futility is applied as binding (the trial
stops).GSD_model$alpha_spending is user-specified cumulative
alpha (typeOfDesign = "asUser").BPP_func() -> PP_func(); its return
element BPP_df -> PP_df.calibrate_BPP_threshold() ->
calibrate_PP_threshold() (returns PP_vec) and
calibrate_BPP_timing() ->
calibrate_PP_timing() (returns
PP_values).summarize_grid_by_lambda() ->
summarize_grid_by_kappa() (argument
kappa_grid, column kappa) and
select_lambda_star() -> select_kappa_star()
(returns kappa_star).GSD_model$futility_type = "BPP" -> "PP"
and GSD_model$BPP_threshold ->
GSD_model$kappa.n_BPP_sims -> PP_sims in
calc_dte_assurance_adaptive(), so the argument has the same
name everywhere.BPP_val column of the calibration output is now
PP_val.lambda_e (in PP_func() and in the
update_priors() JAGS models); the models are otherwise
unchanged.BPP_func(), calibrate_BPP_threshold(),
calibrate_BPP_timing(),
summarize_grid_by_lambda() and
select_lambda_star() still work but warn and forward to
their replacements. Returned element and column names are not translated
back to the old names.futility_type = "BPP" and
GSD_model$BPP_threshold are accepted by
calc_dte_assurance_adaptive() with a warning and mapped to
"PP" and GSD_model$kappa.calc_dte_assurance_adaptive() no longer returns a
Final_Decision column. That column was recomputed
independently from a Cox Wald statistic at a flat threshold, ignoring
analysis_model$method and the design’s boundaries, and
could disagree with Decision. Use the new logical
Success column, which is derived only from
Decision. A Converged column (MCMC convergence
at the BPP interim; NA for other futility types) is also
returned."MatchedZ" futility type: stop for futility at
futility_IF if the interim Z-statistic falls below
GSD_model$futility_boundary_Z.calibrate_matched_futility_boundary() and
single_matched_futility_rep() (calibrate a MatchedZ
boundary), and run_calibration_grid(),
summarize_grid_by_lambda() and
select_lambda_star() (calibrate a BPP futility threshold
over a grid).update_priors() returns Gelman-Rubin diagnostics and
posterior latent-state probabilities as attributes (rhat,
converged, Z_probs).BPP_func() accepts future_boundaries,
evaluating each predictive draw against the design’s remaining efficacy
boundaries rather than a single final test.survival_test(): "MW" now returns Z with
the same sign convention as "LRT"/"WLRT"
(positive Z favours treatment); "WLRT" uses the signed
statistic from nph::logrank.test() directly.survival_test() no longer fails with “could not find
function Surv” when the survival package is not attached.apply_GSD_to_trial() computes interim and final
statistics with analysis_model$method via
survival_test() instead of a hard-coded Cox Wald statistic,
and passes update_priors_sims/n_BPP_sims
through.calc_dte_assurance_adaptive() and
make_rpact_design_from_GSD_model() recognise the
"MatchedZ" futility type.update_priors() to update elicited prior
distributions using interim data.BPP_func() for computing the Bayesian predictive
probability (BPP) from posterior samples.calibrate_BPP_timing() to determine the optimal
timing for BPP-based futility looks.calibrate_BPP_threshold() to calibrate the BPP
threshold for futility decisions.calc_dte_assurance_interim() to
calc_dte_assurance_adaptive() for consistency in adaptive
design terminology.assurance_interim_shiny_app() to
assurance_adaptive_shiny_app().assurance_adaptive_shiny_app().calc_dte_assurance() affecting certain
parameter configurations.calc_dte_assurance() for fixed designs.calc_dte_assurance_interim() for group
sequential designs.These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.