The Challenges of Validating R


The first challenge in validating an analytic tool for the pharmaceutical industry is that, despite a formal FDA definition, there is still no cross-industry agreement on what ‘validation’ really means with respect to an analytic tool. AIMS (Application and Implementation of Methodologies in Statistics), a Special Interest Group within PSI have been attempting to answer this question with respect to R. In doing so we recently received approval from the R Consortium for an online R package validation repository and are now looking to formalise some early definitions. In this presentation I will walk through some of the challenges that we have identified thus far and outline what we’re hoping to achieve with the platform.

Presented at 2018 Conference