AIMS SIG

Objectives

Statisticians, data scientists 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. 

For 2019, our main objectives are:

  1. Key objective: Automation of reporting: Most companies are working towards a time from DB lock to High Level results of 24 hours with just 5 days for the Stats analysis to be complete.  Therefore we’d look to ways to assist with this through the use of technology.   
  2. Key objective: Data visualization:  Looks at technology to enhance visualization of data throughout the study
  3. Work with statisticians and statistical programmers to educate them on Data Science Tools (such as R, GitHub etc)
  4. Bridging the gap between SAS and other software (for example, SAS processes / global macros and do it in Git / GitHub)
  5. Assist other SIGS implement their needs in software/training/support. – Reach out to SIGS (including data science SIG) and ask if we can help with any of their projects & the implementation of them.
  6. R Validation Hub – Continue the work on the Hub project improving the website, and production of R metrics/ tests/ validation documentation


Who we are

The AIMS SIG was formed in May 2016 and currently consists of the following team members:

Name

Company

Role

Lyn Taylor

Phastar, UK

Chair

Craig McIlloney

PPD, UK

Vice-Chair

Andy Nicholls

GSK, UK

R validation Hub Chair

Chris Toffis

SQN Clinical

Jules Hernandez-Sanchez

Roche, UK

 

Yann Roberts

Servier, France

 

Markus Elze

Roche

Karma Tarap

JnJ

Mark Bynens

JnJ



We also have a wider team of experts in the use of R, who are working on the collection of metrics and R validation information.  See the following for more information:  https://www.pharmar.org 



How to get in touch

If you are interested in joining the AIMS SIG, then please contact Lyn Taylor: lyn.taylor@phastar.com
If you are interested in R, and joining the R validation Hub contact: psi.aims.r.validation@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: psi.aims.r.validation@gmail.com.  

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

 

Upcoming Events: PSI Conference 2019

The desire to use R in the pharmaceutical industry is evident due to it being a very powerful object-orientated language, able to produce analyses and high quality graphics and being open source hence readily enabling bespoke extensions.  It can be used for high performance computing and allows easy integration with other software.  It can also be used for complex analyses which is especially important when these analyses are not available in SAS.  The AIMS SIG have been working on a number of initiatives over the last 12 months focused on increasing the use of R in the industry and how R can be used in the regulatory environment through addressing the question surrounding validation.    This session will start with an overview of the AIMS SIGs objectives for 2019, followed by demonstrations using Tidyverse and RMarkdown.   The session will conclude with a summary of the latest status of the R Validation Hub Project.  For more information see: https://www.pharmar.org/

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