AIMS SIG

Objectives

Statisticians and programmers need to continue to develop their technology toolkit and support industry enhancements.  These may cover:

  • New analytical tools
  • Enhancement of existing analysis software packages
  • Evolution of industry data standards and guidelines

Evolutions in theoretical methodology are of little use without clear guidance on how to implement these improvements in industry-standard software. 

The Application and Implementation of Methodologies in Statistics (AIMS) Special Interest Group (SIG) objective is to support PSI Committees and PSI/EFSPI Special Interest Groups (SIGs) with the technological application and implementation of statistics.  To develop understanding of new analytical tools and approaches to share with PSI & EFSPI members via appropriate forums.  To ensure PSI & EFSPI members are supported with understanding the requirements for the implementation of industry data standards. 



Who we are

The AIMS SIG was formed in May 2016.   Our first six months was spent brainstorming to identify an area that would be our initial key focus.  What assistance is most needed in order to develop the statisticians technology toolkit and supporting industry enhancements?

After discussion with the PSI board, the group decided to focus initially on the use of R software in the industry.  See below for our progress towards a freely assessable R validation documentation framework.

The AIMS SIG team consist of:
Craig Mcilloney (PPD)
Lyn Taylor (PRA until Jan 2019, Phastar Feb 2019 onwards)
Chris Toffis (Syne Qua Non)
Yann Robert (Servier)
Sophie Canete (Bordeaux University Hospital, Clinical Epidemiology Unit)
Jules Hernandez-Sanchez (Roche)
Andy Nicholls (GSK)
Markus Elze (Roche) 

We also have a wider team of experts in the use of R who are focusing on putting together the R validation framework on GitHub. See https://github.com/pharmaR and the discussion forum at https://rvalidationhub.slack.com



How to get in touch

If you are a statistician who is interested in R and would like to join our SIG or the R Validation framework group, please contact Lyn Taylor at dr.lyn.taylor@gmail.com.  



Latest News

AIMS SIG presented at the 2018 PSI Conference (www.psiweb.org/psi-2018/psi-conference-2018) in Amsterdam. The title was “The Future is heRe”. Craig introduced AIMS, Jules summarized some of the articles that AIMS published in SPIN and Lyn showed several examples of R Shiny applications including an adverse event tabulation app and laboratory data graphics app, both created by Chris Toffis. 

AIMS was awarded funding from the R-Consortium in June 2018 to create of an online repository for R package validation in accordance with regulatory standards.  Since the main hurdle for widespread use of R in late phase trials is ensuring adequate validation documentation, the AIMS SIG is now focused on designing a framework which will specify a set of requirements, including metadata and examples of tests, which together would form evidence of the quality of an R package.   Initially we will use dplyr as an example, and will make this “evidence of validation” available to the wider community on GitHub.   Whether the evidence provided is sufficient will be the decision of the end user, but it can be a starting point for further testing or may be sufficient in itself depending on the user’s attitude to risk.  After review by our peers and with agreement that the framework is sufficient for use in the regulatory environment, we will be calling on all R users to submit similar evidence of validation for other packages.  By sharing this evidence, we hope to reduce the amount of re-work being done by multiple companies eager to use R, but fearful of doing so in a regulatory environment without documentation of validation.

Andy presented on behalf of AIMS and co-ordinated an R-validation brainstorming workshop at the R/Pharma Conference in August 2018.  This was very well received and resulted in a sub-group being set up to work towards the creation of the R-validation online repository.  This sub-team will meet monthly.  If you are interested in contributing to this project please contact: Lyn Taylor at dr.lyn.taylor@gmail.com.  

If you are new to R then why not explore the freely available training available.

 

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