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Sample size calculation

Functions for calculating fixed sample sizes for negative binomial outcomes.

sample_size_nbinom()
Sample size calculation for negative binomial distribution
print(<sample_size_nbinom_result>)
Print method for sample_size_nbinom_result objects
summary(<sample_size_nbinom_result>)
Summary for sample_size_nbinom_result objects
print(<sample_size_nbinom_summary>)
Print method for sample_size_nbinom_summary objects

Group sequential design

Functions for extending fixed designs to group sequential designs.

gsNBCalendar()
Group sequential design for negative binomial outcomes
toInteger()
Convert group sequential design to integer sample sizes
summary(<gsNB>)
Summary for gsNB objects
print(<gsNBsummary>)
Print method for gsNBsummary objects

Simulation

Tools for simulating trial data.

nb_sim()
Simulate recurrent events with fixed follow-up
nb_sim_seasonal()
Simulate recurrent events with seasonal rates
sim_gs_nbinom()
Simulate group sequential clinical trial for negative binomial outcomes
check_gs_bound()
Check group sequential bounds
summarize_gs_sim()
Summarize group sequential simulation results

Analysis

Functions for analyzing trial data, including blinded sample size re-estimation and interim analysis.

blinded_ssr()
Blinded sample size re-estimation for recurrent events
unblinded_ssr()
Unblinded sample size re-estimation for recurrent events
calculate_blinded_info()
Calculate blinded statistical information
estimate_nb_mom()
Method of Moments Estimation for Negative Binomial Parameters
mutze_test() print(<mutze_test>)
Wald test for treatment effect using negative binomial model (Mutze et al.)
cut_data_by_date()
Cut simulated trial data at a calendar date
cut_completers()
Cut data for completers analysis
cut_date_for_completers()
Find calendar date for target completer count
compute_info_at_time()
Compute statistical information at analysis time
get_analysis_date()
Find calendar date for target event count
get_cut_date()
Determine analysis date based on criteria

gsDesign re-exports

Spending functions and utilities re-exported from the gsDesign package for convenience.