The PHUSE Working Groups are busy throughout the year discussing and developing solutions to challenges and opportunities that clinical data scientists encounter! All the project’s deliverables are available for everyone to use and contribute to via the PHUSE website.

Several of the Working Group Projects are presenting their work at the US Connect. If you’re joining us in Orlando, be sure to attend the below presentations to find out more about their work and how you can contribute to the project.

Emerging Trends & Technologies Working Group

Digital Biomarkers in Clinical Submissions

ST10: Digging Deep into Digital Biomarkers: Empowering Clinical Trials – Vijay Pasapula, Cerus

Real World Evidence

RE02: Learnings from an External Comparator Study Based on Real-world Data (RWD)/Real-world Evidence (RWE) in T-Cell Therapy for Solid Tumours – Rabia Ahmad, GSK

Optimizing the Use of Data Standards Working Group

Best Practices in Data Standards Implementation Governance

DS02: Data Standards Governance and Implementation Across Industry: Key Challenges and Benefits – Matt Baldwin, Amgen

Implementation of Estimands (ICH E9 (R1)) using Data Standards

DS03: Implementation of Estimands (ICH E9 (R1)) Using Data Standards – Lori VanMeter, Janssen Research & Development

Safety Analytics Working Group

PP08: PHUSE Safety Analytics Working Group – Overview and Summary of Ongoing Projects– Mary Nilsson, Eli Lilly & Clio Wu, Chinook Therapeutics