PSI Webinar: Master protocols - theory, application and regulatory considerations
For this webinar, PSI brings together experts on master protocols from the pharmaceutical industry, academia, and regulatory agencies.
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 2020, our main objectives are:
The AIMS SIG was formed in May 2016 and currently consists of the following team members:
|Martin Brown||PPD, UK||Vice Chair|
|Andy Nicholls ||GSK, UK||R validation Hub Chair|
|Chris Toffis||SQN Clinical, UK|
|Jules Hernandez-Sanchez||Roche, UK|
Floating Point Statistics, UK
|Michael Cartwright||parexel, UK|
|Christina Fillmore||GSK, UK|
We are also closely linked to the R Validation Hub who are working on the collection of metrics for R packages and the production of guidance information on the use of R in the pharmaceutical industry. See the following for more information: https://www.pharmar.org
If you are interested in joining the AIMS SIG, then please contact Lyn Taylor: firstname.lastname@example.org
If you are interested in R, and joining the R validation Hub contact: email@example.com
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. 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 acted as a springboard for the R Validation Hub initiative which has now grown
into it's own committee with involvement of over 100 people representing 60 companies. For more information see: https://www.pharmar.org/ If you are interested in contributing to this project please contact:
The team are now looking at the use of gt for production of TFLs to see if using R can make study reporting and CSR creation more efficient. SPIN article to follow!
Substantial free training is available for R. Some of our favourite sources are listed below.
The SIG Charter and our Articles to date are shown below.
The R Shiny Apps created by Chris Toffis and demonstrated at the PSI Conference in 2018 are able to download below. Note that these are intended to demonstrate what R Shiny can do and are not validated apps. The datasets used are dummy and contain no real patient data. PSI and the AIMS SIG accept no responsibility for their use. The ae_app.R is an application for interactive Adverse Event tabulation and labs_app.R creates an app for the graphical presentation and exploration of Laboratory data. SAS datasets are also provided to accompany each app.
Our Meeting Minutes can be located here.