Description Usage Arguments Details Value Note Author(s) References See Also Examples
Find the sample size, duration of accrual, and test boundary for a single-stage design with an event-free endpoint versus either a known standard control or a randomized comparative control. Testing is one-sided based on the Kaplan-Meier estimator evaluated at a user-specified time point.
1 |
B.init |
A vector of user-specified time points (B1, ..., Bb) that determine a set of time intervals with uniform accrual. |
m.init |
The projected
number of patients that can be accrued within the time intervals determined by |
alpha |
Type I error. |
beta |
Type II error. |
param |
Events should be defined as poor outcomes (e.g. death, progression). Computations
and reporting are based on the proportion without an event at a
pre-specified time, |
x |
Pre-specified time for the event-free endpoint (e.g., 1 year). |
num.arm |
Number of treatment arms. |
r |
Proportion of patients randomized to the treatment arm. By default, |
Estimation is based on the Kaplan-Meier or Nelson-Aalen estimators
evaluated at a target time (e.g., 1 year). The event-free rates at the
target
time are computed from Weibull distributions assumed for the treatment
and control distributions, as is done in function OptimDes
.
The design depends only on the event-free rates at the target time (except
for small changes due to rounding with different survival functions).
The duration of accrual depends on the projected maximum accrual rates.
A list with components:
n0 |
Fixed design sample size. |
DA |
Duration of accrual. |
SL |
Total study length ( |
n0E |
n0 based on exact binomial test. |
DAE |
DA based on exact binomial test. |
SLE |
SL based on exact binomial test. |
C |
Rejection cutpoint for the test statistic. |
The single-stage sample size is used as the starting value for evaluating the
optimal n
for a two-stage design in OptimDes
.
Bo Huang <bo.huang@pfizer.com> and Neal Thomas <neal.thomas@pfizer.com>
Huang B., Talukder E. and Thomas N. Optimal two-stage Phase II designs with long-term endpoints. Statistics in Biopharmaceutical Research, 2(1), 51–61.
Case M. D. and Morgan T. M. (2003) Design of Phase II cancer trials evaluating survival probabilities. BMC Medical Research Methodology, 3, 7.
Lin D. Y., Shen L., Ying Z. and Breslow N. E. (1996) Group seqential designs for monitoring survival probabilities. Biometrics, 52, 1033–1042.
Simon R. (1989) Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials, 10, 1–10.
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