Application and Implementation of Methodologies in Statistics (AKA: The R SIG!)

Overview
The AIMS SIG key objective is to act as an intermediary between groups working with R in the Biopharmaceutical industry and to share this information with the wider PSI community.   We also help with other PSI initiatives like the medical statistician apprenticeship scheme.  Our SIG members represent PSI on the wide variety of groups described below.  Each member then feeds back to the central team, sharing ideas, brainstorming solutions together and promoting collaborations.  If you would like to join this SIG or if you have questions about any of the below initiatives, please contact: psi.aims.r.validation@gmail.com.

Updates & Highlights
Our SIG members are currently involved with following initiatives, so we’ve listed some of the key achievements of 2021:

• R Validation Hub including riskmetric and the r shiny app. https://www.pharmar.org/
       - cran release of ‘riskmetric’ which aids users to assess R packages against a number of metrics to help quantify their robustness - read more
       - Further development of the shiny app (the front interface for riskmetric) - read more

• Following the successful delivery of the “R for SAS Users” PSI training courses, you are now invited to participate in a “R for clinical trial simulations” training course on 14^th March 2022. Register here.

• R Consortium working groups are really bringing people together to build on the use of R in the regulatory setting:
  • R Tables for regulatory submissions - more
  • Submissions - more
  • R adoption series - more
• phuse initiative: The clinical statistical reporting in a multi-lingual world team are exploring key differences between SAS and R results using examples from survival analysis, CMH, linear and mixed models. The team are now working towards release of a white paper - read more

• The Medical Statistician Apprenticeship Scheme is now live. Employers can start the process to recruit an apprentice and register them onto the scheme to start in September 2022. The apprenticeship standard can be found here. For more information, visit our webpage.

Finally, news for 2022! The PSI AIMS SIG Conference session will be 4pm on 14^th June entitled “A showcase of using R for regulatory work.” Please join us at the PSI conference and come meet the PSI AIMS SIG team.

In this conference session, PSI AIMS SIG will demonstrate case studies using R for regulatory work in pharmaceutical research. The session will include some of the challenges and possible solutions, ranging from implementation of a full R platform to using R for a single piece of work. Particular focus will be on the methods used for implementation of an R platform at PHASTAR, followed by details of the process used at GSK for creating a platform for a full submission in R. In addition, several discrepancies have been discovered in statistical analysis results between different programming languages, even in fully qualified statistical computing environments. The Clinical Statistical Reporting in a Multilingual World (CSRMW) project seeks to clearly define this problem and provide a framework for assessing the fundamental differences for a particular statistical analysis across languages. This presentation will provide an update on the CSRMW project and will demonstrate one of the use cases the team has investigated - Implementation of Survival Analyses in R vs. SAS.

AIMS SIG Chair - Lyn Taylor

As SIG Chair, I would like this opportunity to give special thanks to the all the lovely AIMS SIG members for their contribution and dedication over many years. 

AIMS SIG team: Andy Nicholls (GSK), Chris Toffis (SQN Clinical), Christina Fillmore (GSK), Jules Hernadez-Sanchez (Roche), Mark Bynens (JnJ), Martin Brown (PPD), Matt Neilson (PHASTAR), Michael Cartwright (PAREXEL), Michael Grayer (Floating point statistics),
Min-Hua Jen (Eli Lilly) and Yann Robert (Sevier)