OCS Life Sciences was at the PSI Conference

Introduction 

In July was the PSI Conference in Gothenburg.  Our colleagues Mariska and Diana visited this event and came back with great story's, experiences and lots of inspiration. We are thrilled to share them with you. 

Diana Ferreira

Some learning from DAY 2, session PSI AIMS SIG: A showcase of using R for Regulatory work

The transition to open science and multilingual statistical reporting were key elements of 2022 PSI Conference. Therefore, it is no wonder that R, being an extensible, open-source language with a strong developer and support community, was the topic of many talks and posters. To help us with the challenges of adopting an open-source language in such a tightly regulated industry, the session introduced the cross-industry working groups researching the use of R in Pharma (R consortium working groups: CSRMLW, RTRS; R Validation Hub; PhUSE; Pharmaverse), as well as useful resources and case studies to kick-start any curious mind. Road maps to responsibly use and build confidence in R were showcased. The creation of a frozen R environment, the use of Riskmetric to validate packages, and the performance of double programming (with R) are such great tips! Lastly, one could hear the audience sigh of relief when it was shown that SAS and R, most of the time, yield results that match and provided troubleshooting pointers for when that is not the case.

At OCS Life Sciences we are keeping our eyes peeled for the announced new white papers and R packages!

The most important tags 

Mariska Burger

The PSI 2022 conference were packed with interesting plenary sessions, presentations, workshops and posters.  In the presentations and workshops there were a lot of focus on implementing the estimand framework of the ICH E9 guideline and speakers shared the estimand journey of Roche with us with some practical tips on how to get all stakeholders involved in the “estimand” discussion. There was also an interesting presentation on using Single World Intervention Graphs (SWIGS) to visualize the estimand and how to use this to communicate it to the different stakeholders.  Another focus at this year’s conference was on adaptive designs and specifically in platform trials, basket trials and umbrella trials.  Good strategies were shared of how to control the family wise error rate for these types of trials and how to develop a master protocol. There was an introduction to the EU-PEARL framework to design and conduct platform trials.

I also had the privilege to present my poster titled Non-parametric analysis: Distribution free, but not assumption free at the PSI 2022 conference.  The poster session was kicked of by a “gone in 60 seconds” poster presentation session allowing each presenter to introduce their poster in only 60 seconds.  If your 60 seconds expired you were gonged out by a bell .  All attendees then had the time to view and discuss the posters of their choice over a glass of bubbly and some snacks.  I had some interesting discussions and thought generating ideas on my poster and also got to meet a co-presenter who presented his poster titled No assumptions, no problem: Non-parametric tests next to my poster.  “No assumptions” versus “Not assumption free” obviously also led to some interesting discussions.

Off course there were some time for networking, meeting new people, building relationships with old connections and last but not least socializing and having fun with fellow statisticians on the beat of some ABBA hits from the 70’s!

Thank you to #OCS Life Sciences for the opportunity to attend the PSI 2022 conference and to all the sponsors who made this year’s event a huge success.