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CDISC has become the pharmaceutical industry’s standard when preparing our study datasets as part of a submission for regulatory approval and has been a game-changer in having a more mutual understanding of the data and the associated inferences between sponsor and regulator. The use of RWD in our study designs presents new challenges in CDISC compliance. RWD can be more complicated, coming from a whole range of sources, where the collection of different variables is more, or less, carefully controlled; variable-naming conventions, data structures and the purposes of collection are equally varied. Finding ways to transform this data to the CDISC standard is a test for both us and the standard and is always a lively topic of discussion! 

During this Community Forum, presenters will share their experiences on just this – the challenges they encountered and the solutions they came up with when working with RWD and CDISC standards.

This Community Forum event will take place over Teams on 5 October 14:00–15:00 (BST)/09:00–10:00 (EDT). Join the post-meeting discussions by adding your comments and questions to the Disqus forum below. Just log in with your Disqus, Facebook, Twitter or Google account to get started!insert abstract / summary 

Register here!

Lauren Green, Amgen

Lauren Green is a Biostatistical Programming Senior Manager at Amgen, where she provides leadership to the US-based oncology therapeutic area pipeline programming team. As the programming lead, she supports the execution of oncology-related real-world evidence observational studies and collaborates closely with epidemiologists and product leads in their respective spaces. In her career, Lauren has led additional efforts in the evaluation of real-world data aimed at improving the quality, safety and value of healthcare, publishing papers in emergency medicine, internal medicine and medical education. Her main interests include dissecting the challenges of real-world data (RWD) and the unprecedented opportunity it provides in preventative medicine and population health.

Christine Rossin, Pfizer

Jeff Abolafia, Pinnacle 21

Jeff Abolafia is currently Director of Product Innovation at Pinnacle 21 and supports multiple offices at the FDA. Previously, Jeff held the position of Chief Strategist of Data Standards and was a member of the faculty in the Department of Biostatistics at the University of North Carolina. He has been involved with public health research and data standards for over 30 years. Jeff co-founded the RTP CDISC User’s Group and is a member of the CDISC ADaM and Analysis Results teams and several PHUSE Real World Evidence Working Group Projects. His areas of interest include regulatory submissions, real-world evidence, mobile health, data standards and bioinformatics.

Sandra VanPelt Nguyen, Pfizer

Sandy VanPelt Nguyen has been working in clinical research for over 20 years and has been involved with PHUSE since 2015. She currently co-leads the Best Practices in Data Standards Governance Implementation project and supports the Clinical Integrated Study Data and Analysis Data Reviewer’s Guide and Submitting Real World Data projects. Sandy works at Pfizer as a Director in the Submissions and Standards team, focused on end-to-end data standards implementation, governance and optimisation.