| Name : R-seqDesign
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| Version : 1.2
| Vendor : obs://build_opensuse_org/devel:languages:R
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| Release : lp153.2.13
| Date : 2024-06-14 11:13:39
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| Group : Development/Libraries/Other
| Source RPM : R-seqDesign-1.2-lp153.2.13.src.rpm
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| Size : 0.47 MB
| |
| Packager : (none)
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| Summary : Simulation and Group Sequential Monitoring of Randomized Two-Stage Treatment Efficacy Trials with Time-to-Event Endpoints
|
Description :
A modification of the preventive vaccine efficacy trial design of
Gilbert, Grove et al. (2011, Statistical Communications in Infectious
Diseases) is implemented, with application generally to
individual-randomized clinical trials with multiple active treatment
groups and a shared control group, and a study endpoint that is a
time-to-event endpoint subject to right-censoring. The design accounts
for the issues that the efficacy of the treatment/vaccine groups may
take time to accrue while the multiple treatment
administrations/vaccinations are given; there is interest in assessing
the durability of treatment efficacy over time; and group sequential
monitoring of each treatment group for potential harm,
non-efficacy/efficacy futility, and high efficacy is warranted. The
design divides the trial into two stages of time periods, where each
treatment is first evaluated for efficacy in the first stage of
follow-up, and, if and only if it shows significant treatment efficacy
in stage one, it is evaluated for longer-term durability of efficacy in
stage two. The package produces plots and tables describing operating
characteristics of a specified design including an unconditional power
for intention-to-treat and per-protocol/as-treated analyses; trial
duration; probabilities of the different possible trial monitoring
outcomes (e.g., stopping early for non-efficacy); unconditional power
for comparing treatment efficacies; and distributions of numbers of
endpoint events occurring after the treatments/vaccinations are given,
useful as input parameters for the design of studies of the association
of biomarkers with a clinical outcome (surrogate endpoint problem). The
code can be used for a single active treatment versus control design
and for a single-stage design.
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RPM found in directory: /packages/linux-pbone/ftp5.gwdg.de/pub/opensuse/repositories/devel:/languages:/R:/autoCRAN/openSUSE_Leap_15.3/x86_64 |
