On CRAN 2021-11-20

- New development version

- False
`df`

for`n2>0`

in`sampleN2.TOST()`

fixed.

- LazyData: yes entry from DESCRIPTION removed since no data folder was available. Caused a NOTE during R CMD check instead of Ok.

On CRAN 2021-01-16.

- Subtract/add
`.Machine $double.eps`

if`rho`

±1 in`power.tsd.2m()`

to prevent error in`rWishart()`

.

- Argument
`min.n2`

introduced in`power.tsd.p()`

. - README.md knitted from README.Rmd.
- NEWS.md instead of NEWS.

- Badges in READMEs like in PowerTOST,
`session_info()`

added. - Argument
`min.n2`

in man-pages of`power.tsd()`

and`power.tsd.fC()`

more correctly explained. - Stop
`interim.2stage.in()`

if n1 <3 and`final.tsd.in()`

if n1 | n2 <3 (avoids errors and warnings). - References in man-pages of
`*.tsd.in()`

corr. - Refined printing of results for
`interim.tsd.in()`

and`power.tsd.in()`

. - Make internal power (and sample size) function more consistent wrt different alphas

On CRAN 2019-04-21.

Maintenance release with mainly bug fixes.

- Calculation of median unbiased estimate in
`final.tsd.in()`

. `power.tsd.GS()`

regarding variable`hw`

.`interim.tsd.in()`

w.r.t to power > target triggering futility fixed (THX to mittyri).

- Typos and minor wording and formatting corrections (man pages and
`*.tds.in()`

).

On CRAN 2018-04-03.

- New functions
`interim.2stage.in()`

and`final.2stage.in()`

to perform interim and final analyses of 2 stage designs based on the Standard Combination or Maximum Combination Test (also includes a print class).

- All functions
`xyz.2stage.ab()`

now have an alias`xyz.tsd.ab()`

, e.g. instead of`power.2stage.fC()`

one may use`power.tsd.fC()`

. The versions with`.2stage.`

in their names will be removed in later versions. - The futility rule for a CI in
`power.2stage.GS()`

is now based on the 90% CI to be in line with the other functions using such a futility rule. - Default of argument
`fCrit`

in`power.2stage.GS()`

changed to`"CI"`

. - Updated defaults of
`power.2stage.in()`

in order to be consistent with paper of Maurer et al (2018). - Aliases
`power.tsd.xyz`

introduced (not public yet). - Experimental function
`power.tsd.2m()`

to deal with 2 PK metrics in the TSD decision scheme Potvin “B” (not public yet).

On CRAN 2017-10-27.

- New function
`sampleN2.TOST()`

to estimate`n2`

in 2x2 and parallel designs based on`df=n-3`

in stage 2. - df for sample size re-estimation changed to
`n-3`

for Potvin like TSD schemes (pooled evaluation with additionally stage term). - As above for
`power.2Stage.ssr()`

. - Function
`power.2stage.in()`

to calculate the operational characteristics of TSDs evaluated via p-value combination using the inverse normal approach. Contributed by Benjamin Lang.

- GitHub URL and bug reports URL added.

On CRAN 2017-01-18.

Maintenance release to reflect changes in power calculation of package PowerTOST.

- Bug in
`power.2stage.p()`

and`power.2stage.pAF()`

removed which caused negative residual variances in case of`test="anova"`

and imprecise power values in all other cases for certain scenarios of n1, CV.

- DOI of references in man pages added.
- Large sample approximation for the sample size adapted to deal with asymmetric BE acceptance ranges, one limit = Inf allowed.
- Small cosmetic changes in code w.r.t min.n2

Internal only 2016-01-21 (not released via CRAN).

- Method
`"B0"`

(re)introduced in`power.2stage()`

and`power.2stage.fC()`

which employs the decision scheme of the so-called MSDBE (Modified Sequential Design for BE) of Zheng et al. - Method
`"B"`

in`power.2stage.p()`

and`power.2stage.pAF()`

also adapted todecision scheme E of Xu et al.

- Figures with TSD decision schemes added in
`/doc`

subdirectory.

On CRAN 2015-11-24.

`power2stage.fC()`

has a new argument`max.n`

which constraints the total sample size.- Method
`"B"`

in`power2stage.fC()`

and`power.2stage()`

redefined to deal with unequal`alpha[1]`

and`alpha[2]`

in the same manner as method E in Xu et al.This gives small differences compared to previous calculations with unequal alphas, f.i. Haybittle-Peto alphas. - The CI futility criterion is now based on the 90% CI according to Xu
et al. It was formerly the
`1-2*alpha[1]`

CI. - Default futility criterion changed to
`"CI"`

with a lower bound 0.925. - Defunct
`print`

argument removed from all`power.2stage.xyz()`

functions.

On CRAN 2015-07-13.

- Bug removed in
`power.2stage.ssr()`

which prevented correct sample-size re-estimation if power was calculated via`pmethod="ls"`

.

- New argument
`usePE`

in`power.2stage.ssr()`

to use the point estimate from the interim analysis in sample-size re-estimation (makes only sense if`blind=FALSE`

).

On CRAN 2015-06-19.

- Major rewrite of the
`power.2stage.xyz()`

functions wich now return an S3 object of class`"pwrtsd"`

. Output is now done more R-like via the S3 print method for class`"pwrtsd"`

. Therefore, the`print`

argument is defunc and will be removed in the next version. - The
`power.2stage.xyz()`

functions (except`power.2stage.GS()`

) return a component`ntable`

, a ‘table’ object for summarizing the discrete distribution of`ntotal`

. The`nhist`

component was removed. - The default of
`fClower`

in case of`fCrit="PE"`

changed to 0.8 in function`power.2stage.fC()`

.

- The argument
`detail`

has now the default`FALSE`

. Thus be patient if you simulate for alpha with 1 mio sim’s. - The
`nsims`

argument, if missing, is now set to 1E6 if you simulate for alpha (i.e. with`theta0`

at border or outside acceptance range`theta1 ... theta2`

) and to 1E5 otherwise.

Released to alpha testers only 2015-06-10.

- The
`power.2stage.yy()`

functions (except`power.2stage.GS()`

) now return a component`nhist`

with class`"histogram"`

which can be used with`plot()`

to visualize the distribution of`Ntotal`

. Suggested by H. Schuetz. - Handling of non-integer degrees of freedom in
`power.2stage.p()`

in case of Welch’s test changed (mo more truncation). - Power calculation method
`"shifted"`

implemented in`power.2stage.fC()`

.

- Slight improvements and typo fixes in man pages.

On CRAN 2015-01-24 (dedicated to my brother Stefan’s 50 birthday).

- Revision to reflect internal changes in upcoming PowerTOST v1.2-06 ‘raw’ power functions.
- Sample-size estimation routine (vectorized!) reworked which gives a considerable run-time boost.
- Internal change of start value of sample size estimation to Zhang’s
formula (may change the extremal value of n and its mean if
`usePE=TRUE`

). `power.2stage.p()`

accepts now unbalanced stage 1 and uses the correct power of Welch’s test in the power monitoring steps and in sample size estimation.- Former function
`power.2stage.p()`

now available as`power.2stage.pAF()`

which performs the calculations exactly as described in Fuglsang’s paper.

On CRAN 2014-12-08.

- Two nasty bugs removed.

Released to alpha-testers only 2014-12-06 (dedicated to my daughter Antje’s 40 birthday).

- Deprecated function
`power.2stage.Bf()`

removed. - Functions
`power.2stage()`

and`power.2stage.fC()`

have now an argument`min.n2`

to restrict the sample size of stage 2 to a lower limit. - Calculation of % studies in stage 2 re-defined to studies having total n>n1 (was in the past studies which had to be evaluated with alpha2; affects only asymmetric alpha settings).
- Function
`power.2stage.ssr()`

for (blinded) sample size re-estimation added (2-stage design without BE decision at interim).

- Code streamlining, enhancements and unification of output of power functions.

On CRAN 2014-10-09.

`power.2stage.Bf()`

reworked into the new function`power.2stage.fC()`

to include Potvin method “C” and to include an additional futility criterion for the CI as well.`power.2stage.Bf()`

is deprecated and will not be removed in one of the next versions. Use`power.2stage.fC()`

instead.

On CRAN 2014-07-24.

- Bug in
`power.2stage.GS()`

removed which prevented the convergence of power values with increasing number of sim’s.

On CRAN 2014-07-02.

- Internal change of start value of sample size search to avoid failed
searches if variability is high and
`theta0`

close to 1.

- Power calculation method
`"shifted"`

added in`power.2stage()`

to the provide comparison with Potvin et al.

Not released to the public (special version to alpha testers)

On CRAN 2014-05-08.

Released to alpha testers 2014-04-24.

- New function
`power.2stage.p()`

for calculation of power in BE studies with sequential (2-stage) designs in 2 parallel groups acc. to Fuglsang.

- Internal code streamlining.

On CRAN 2014-04-11.

- Bug in
`power.2stage.KM()`

removed if using`method="B"`

(Karalis TSD-2). Thanks to Helmut Schuetz!

- Man page of
`power.2stage.KM()`

changed to the correct definition of the Karalis/Macheras TSD or Karalis TSD-1, TSD-2 respectively. # Power2Stage 0.0-7 On CRAN 2014-02-13. Maintenance release to reflect changes in PowerTOST V1.1-10.

- New function
`power.2stage.GS()`

for non-adaptive group sequential (2-stage) BE studies.

On CRAN 2014-01-02.

- Examples adapted to complain with CRAN policy “Examples should run for no more than a few seconds each”. Few seconds means below 5 sec as I learned. Attention! Number of sim’s are too low to get meaningful results. Minimum number of sim’s should be 1E5 for ‘power’, 1E6 for ‘alpha’.

First attempt to release via CRAN 2013-12-27.

Not released, internal version only 2013-09-12.

- Default method in
`power.2stage.KM()`

changed to`"C"`

. - Arguments in
`power.2stage.KM()`

removed which are not necessary for the TSDs described in the Karalis & Macheras and in Karalis papers (see references). `power2.2stage()`

renamed to`power.2stage.KM()`

.- New function
`power.2stage.Bf()`

implemented which evaluates a 2-stage design derived from Potvin method B with a futility criterion for the PE of stage 1.

Released to alpha testers 2013-09-03.

- New function
`power2.2stage()`

implemented which uses PE and MSE of stage 1 also for the power calculation steps if`usePE=TRUE`

.

Released to alpha testers 2013-07-10.

- Bug in output removed stating that the sample size is estimated with
PE & mse from stage 1 even if argument
`usePE=FALSE`

. THX to Helmut.

- Default for
`npct`

argument changed to`c(0.05, 0.5, 0.95)`

in accordance with the Potvin papers. - Cases with n(total)>Nmax now counted at stage 1 since I feel this is more logical.
- Internally stage vector introduced and output based on that.

- More checks of input added. THX to Helmut Schuetz.

First release to alpha testers 2013-07-09.