NEWS.md

In Mediana: Clinical Trial Simulations

Mediana 1.0.8

New features

• Create an hexagon sticker for the package.

Bug fixes

• Fix the calculation of intersection hypothesis pvalue when family weights is null for all gatekeeping procedures.

• Revise the error fraction function to avoid floating point issue

• Fix the images in the Case studies vignette

• Revise the specification of serial and parallel parameters in MixtureGatekeepingAdj (matrix instead of list)

• Revise the Outcome table generation function used for reporting

Mediana 1.0.7

Bug fixes

• As the ReporteRs R package is not available on the CRAN anymore, the report generation feature has been revised using the officer and flextable R packages. These packages are now required to use the GenerateReport function.

Mediana 1.0.6

New features

• Addition of the multinomial distribution (MultinomialDist, see Analysis model).

• Addition of the ordinal logistic regression test (OrdinalLogisticRegTest, see Analysis model).

• Addition of the Proportion statistic (PropStat, see Analysis model).

• Addition of the Fallback procedure (FallbackAdj, see Analysis model).

• Addition of a function to get the analysis results generated in the CSE using the AnalysisStack function (see Analysis stack).

• Addition of the ExtractAnalysisStack function to extract a specific set of results in an AnalysisStack object (see Analysis stack).

• Creation of a vignette to describe the functions implementing the adjusted p-values (AdjustPvalues) and one-sided simultaneous confidence intervals (AdjustCIs).

• Minor revisions of the generated report

• It is now possible to use an option to specify the desirable direction of the treatment effect in a test, e.g., larger = TRUE means that numerically larger values are expected in the second sample compared to the first sample and larger = FALSE otherwise. This is an optional argument for all two-sample statistical tests to be included in the Test object. By default, if this argument is not specified, it is expected that a numerically larger value is expected in the second sample (i.e., by default larger = TRUE).

Bug fixes

• Due to difficulties for several users to install the Mediana R package because of java issue, the ReporteRs R package is not required anymore (remove from Imports). However, to be able to generate the report, the user will require to have the ReporteRs R package installed.

• Minor revision to the two-sample non-inferiority test for proportions to ensure that the number of successes is not greater than the sample size

Mediana 1.0.5

New features

• Addition of the AdjustPvalues function which can be used to get adjusted p-values from a Multiple Testing Procedure. This function cannot be used within the CSE framework but it is an add-on function to compute adjusted p-values.

• Addition of the AdjustCIs function which can be used to get simultaneous confidence intervals from a Multiple Testing Procedure. This function cannot be used within the CSE framework but it is an add-on function to simultaneous confidence intervals.

• Creation of vignettes

Bug fixes

• Revision of the dropout generation mechanism for time-to-event endpoints.

Mediana 1.0.4

New features

• Addition of the Fixed-sequence procedure (FixedSeqAdj, see Analysis model).

• Addition of the Cox method to calculate the HR, effect size and ratio of effect size for time-to-event endpoint. This can be accomplished by setting the method argument in the parameter list to set-up the calculation based on the Cox method. (par = parameters(method = "Cox"), see Analysis model).

• Addition of the package version information in the report.

Bug fixes

• Revision of one-sided p-value computation for Log-Rank test.

• Revision of the call for Statistic in the core function (not visible).

• Revision of the function to calculate the Hazard Ratio Statistic (HazardRatioStat method). By default, this calculation is now based on the log-rank statistic ((O2/E2)/(O1/E1) where O and E are Observed and Expected event in sample 2 and sample 1. A parameter can be added using the method argument in the parameter list to set-up the calculation based on the Cox method (par = parameters(method = "Cox"), see Analysis model).

• Revision of the function to calculate the effect size for time-to-event endpoint (EffectSizeEventStat method, based on the HazardRatioStat method)

• Revision of the functions to calculate the ratio of effect size for continuous (RatioEffectSizeContStat method), binary (RatioEffectSizePropStat method) and event (RatioEffectSizeEventStat method) endpoint.

• Revision of the function to generate the Test, Statistic, Design and result tables in the report.

Mediana 1.0.3

New features

• Addition of the Beta distribution (BetaDist, see Data model).

• Addition of the Truncated exponential distribution, which could be used as enrollment distribution (TruncatedExpoDist, see Data model).

• Addition of the Non-inferiority test for proportion (PropTestNI, see Analysis model).

• Addition of the mixture-based gatekeeping procedure (MixtureGatekeepingAdj see Analysis model).

• Addition of a function to get the data generated in the CSE using the DataStack function (see Data stack).

• Addition of a function to extract a specific set of data in a DataStack object (see Data stack).

• Addition of the "Evaluation Model" section in the generated report describing the criteria and their parameters (see Simulation report).

Bug fixes

• Revision of the generation of dropout time.

• Correction of the NormalParamAdj function.

• Correction of the FisherTest function.

Mediana documentation built on May 8, 2019, 5:04 p.m.