*! version 0.7 23may2023

Title

ART -- ANALYSIS OF RESOURCES FOR TRIALS. Suite of commands for complex sample size calculations in randomized controlled trials with
a survival or a binary outcome.

artbin calculation of sample size or power in trials with a binary outcome, including non-inferiority / substantial-superiority trials and superiority trials with k groups.

artsurv calculation of sample size or power in trials with a survival outcome.

Description

ART is a suite of programs for the calculation of sample size or power for complex clinical trial designs under a
survival time or binary outcome. The package is able to handle noninferiority/substantial-superiority 2-group designs and superiority trials
with k-groups.

Changes from artbin version 1.1.2 to version 2.0.2

For the complete list of changes please see artbin_whatsnew. The main changes are listed below.

New features:

A margin(#) option for 2-group trials has been included.

The user can now specify whether the outcome is favourable or unfavourable for a
2-group trial.

The wald option has also been included for the Wald test.

The local option has been included for local alternatives, otherwise the default distant
will be used.

Sample size per group is now reported, and rounding up to the nearest integer is performed
per group.

A noround option has been included for the case when the user does not want artbin
to round the calculated sample size.

A loss to follow-up option is now available (ltfu(#)).

New syntax:

Some improvements have been made to artbin. The user will need to alter previous coding using artbin to
accomodate the following changes.

The syntax for artbin has been updated to include a margin(#) option for 2-
group trials. For a non-inferiority/substantial-superiority trial the program will use pr(p1 p2) AND the new
option margin(#). For example, in the previous version (artbin 1.1.2) the syntax artbin, pr(.2 .3) ni(1)
will now be specified as artbin, pr(.2 .2) margin(.1). The option ni() is now redundant.

Previously local was taken as the default in superiority trials, now it is distant: the distant(#) option has been replaced by local in the syntax. Previous syntax (up to version 1.1.2) will need to be altered
so that artbin, pr(.1 .2) distant(1) will now be artbin, pr(.1 .2) and artbin, pr(.1 .2) distant(0)
will now be artbin, pr(.1 .2) local, for example.

The user is to identify whether the outcome is favourable or unfavourable in the context of a trial. With this information
plus the margin the program will then determine the type of trial (i.e. non-inferiority/substantial-superiority/superiority). If the user does
specify favourable/unfavourable the program will check the assumptions, if not then the program will infer it. The force
option can be used to override the program's inference of the favourability status, for example in the design of observational studies.

References

Royston, P., & Barthel, F. M. S. (2010). Projection of power and events in clinical trials with a time-to-event outcome. Stata Journal, 10 (3), 386-394.

Barthel, F. M. S., Royston, P., & Parmar, M. K. B. (2009). A menu-driven facility for sample-size calculation in novel multiarm, multistage randomized controlled trials with a time-to-event outcome. Stata Journal, 9 (4), 505-523.

Barthel, F. M. S., Royston, P., & Babiker, A. (2005). A menu-driven facility for complex sample size calculation in randomized controlled trials with a survival or a binary outcome: Update. Stata Journal, 5 (1), 123-129.

Marley-Zagar E, White IR, Royston P, Barthel F M-S, Parmar M, Babiker AG.
artbin: Extended sample size for randomised trials with binary outcomes.
Stata Journal, in preparation.

Author and updates

Abdel Babiker, MRC Clinical Trials Unit at UCL

Ab Babiker

Friederike Maria-Sophie Barthel, formerly MRC Clinical Trials Unit

Sophie Barthel

Babak Choodari-Oskooei, MRC Clinical Trials Unit at UCL

Babak Oskooei

Patrick Royston, MRC Clinical Trials Unit at UCL

Patrick Royston

Ella Marley-Zagar, MRC Clinical Trials Unit at UCL

Ella Marley-Zagar

Ian White, MRC Clinical Trials Unit at UCL

Ian White

Also see

Manual: [R] sampsi
Manual: [R] power

Online: help for artmenu, artbin, artbindlg