All opinions expressed are those of the presenter and do not represent any organization.
Some slides need to be scrolled down to see the full content.
May 2022
All opinions expressed are those of the presenter and do not represent any organization.
Some slides need to be scrolled down to see the full content.
“FDA does not require use of any specific software for statistical analyses, and statistical software is not explicitly discussed in Title 21 of the Code of Federal Regulations [e.g., in 21CFR part 11]. However, the software package(s) used for statistical analyses should be fully documented in the submission, including version and build identification.”
As an organization, we need to ensure compliance and reduce the risk of using R and R packages in regulatory deliverables.
gsDesign
: an R package for group sequential design under proportional hazards.simtrial
, gsDesign2
, and gsdmvn
: experimental R packages for group sequential design under non-proportional hazards“Sponsors should provide the software programs used to create all ADaM datasets and generate tables and figures associated with primary and secondary efficacy analyses. Furthermore, sponsors should submit software programs used to generate additional information included in Section 14 CLINICAL STUDIES of the Prescribing Information (PI)26 if applicable. The specific software utilized should be specified in the ADRG. The main purpose of requesting the submission of these programs is to understand the process by which the variables for the respective analyses were created and to confirm the analysis algorithms. Sponsors should submit software programs in ASCII text format; however, executable file extensions should not be used.”
Although FDA did not expect submitted R code is executable, sponsor shall enhance reproducibility.
We share the same philosophy described in Section 1.1 of R Packages book and quote here.
Tools:
r2rtf
: create production-ready tables and figures in RTF format.pkglite
: represent and exchange R package source code as text files.cleanslate
(under internal validation): create portable R environments.Bookdown: https://r4csr.org/