gsDesignNB 0.2.6
gsDesignNB 0.2.5
- Added
rr0 parameter to
sample_size_nbinom() and blinded_ssr() to
support non-inferiority and super-superiority testing.
- Changed default
event_gap to 0 in
nb_sim().
gsDesignNB 0.2.4
- Fix
cut_date_for_completers() to support
nb_sim_seasonal() output (no tte column).
- Correct
calculate_blinded_info() blinded information
calculation to use subject-level exposure.
gsDesignNB 0.2.3
- Fix
toInteger.gsNB() to avoid unintended power changes
by correctly recomputing information with max_followup,
preserving delta1, and improving ratio-aware integer
rounding.
- Vignette updates and documentation fixes.
gsDesignNB 0.2.2
Sample size and power
sample_size_nbinom() computes sample size or power for
fixed designs with two treatment groups. Supports piecewise accrual,
exponential dropout, maximum follow-up, and event gaps. Implements the
Zhu and Lakkis (2014) and Friede and Schmidli (2010) methods.
Group sequential designs
gsNBCalendar() creates group sequential designs for
negative binomial outcomes, optionally attaching calendar-time analysis
schedules (via analysis_times) compatible with gsDesign.
Inherits from both gsDesign and
sample_size_nbinom_result classes.
compute_info_at_time() computes statistical information
for the log rate ratio at a given analysis time, accounting for
staggered enrollment.
toInteger() rounds sample sizes in a group sequential
design to integers while respecting the randomization ratio.
Simulation
nb_sim() simulates recurrent events for trials with
piecewise constant enrollment, exponential failure rates, and piecewise
exponential dropout. Supports negative binomial overdispersion via gamma
frailty and event gaps.
nb_sim_seasonal() simulates recurrent events where
event rates vary by season (Spring, Summer, Fall, Winter).
- Group sequential simulation helpers:
sim_gs_nbinom()
runs repeated simulations with flexible cut rules via
get_cut_date(), check_gs_bound() updates
spending bounds based on observed information, and
summarize_gs_sim() summarizes operating characteristics
across analyses.
Interim data handling
cut_data_by_date() censors follow-up at a specified
calendar time and aggregates events per subject, adjusting for event
gaps.
get_analysis_date() finds the calendar time at which a
target event count is reached.
cut_completers() subsets data to subjects randomized by
a specified date.
cut_date_for_completers() finds the calendar time at
which a target number of subjects have completed their follow-up.
Statistical inference
mutze_test() fits a negative binomial (or Poisson)
log-rate model and performs a Wald test for the treatment effect,
following Mütze et al. (2019).
Blinded sample size
re-estimation
blinded_ssr() estimates blinded dispersion and event
rate from interim data and re-calculates sample size to maintain power,
following Friede and Schmidli (2010).
calculate_blinded_info() estimates blinded statistical
information for the log rate ratio from aggregated interim data.
Re-exports from gsDesign
- Re-exports
gsDesign(), gsBoundSummary(),
and common spending functions (sfHSD(),
sfLDOF(), sfLDPocock(), and more) for
convenience.