It was another great year for the Launch and Lifecycle SIG–a group of statisticians interested in increasing the influence of statisticians to optimize evidence generation and inform clinical practice. The SIG meets monthly to discuss how to shape the field, common challenges and opportunities in the post-approval space, and solutions. If you would like to learn more or join our SIG, please find us on the web here or reach out to co-leads yulia.dyachova@merck.com or jenny.devenport@roche.com.
Wishing everyone an impactful 2025!
Publications
Do You Want to Stay Single? Considerations on Single-Arm Trials in Drug Development and the Postregulatory Space
Published manuscript: link
The Effective Statistician Conference Session
EFSPI Regulatory Conference (Basel) - LnL SIG poster
Ongoing work
- (in collaboration with other SIGs) - Implementation of estimands in RWD studies to evaluate questions of interest in the post-marketing space
- Translating concepts like treatment patterns in practice to the estimand framework
- Different types of intercurrent and / or competing events that occur in the real-world
- Challenges with estimands inherent to RWD
- Various presentations on integrated evidence plans: The Evidence Odyssey: From Clinical Trial Data to Clinical Practice Success