Online Program

Using R in a Regulated Environment (302972)

Keywords: R, group sequential design, graphics, document generation

We present cases where we have used R programs for statistical design and analysis in the pharmaceutical industry. One common application is the gsDesign R package, but graphics and other modeling packages also provide attractive opportunities. gsDesign was developed internally at Merck and qualified by external experts; it now has a web interface to make it particularly easy to use. We also discuss other packages of potential interest to industry statisticians. Use of R in a regulatory environment has a strong justification based on work by the R core group. An attractive feature of R is the ability to produce documents by combining text markdown (R markdown) and R code. This can be translated immediately to Word, PDF, or HTML output. This allows combining both R code and standard descriptive language in a single template document.