Innovations and Challenges In Interim Analyses in Clinical Trials

Innovations and Challenges with the Use of Interim Analyses in Clinical Trials

Group-sequential trials (GSDs) involve pre-planned, repeated comparisons between two competing treatment strategies that are stopped as soon as a decision can be made as to whether one treatment strategy can be regarded as superior to another, or both are equally effective. Specifically, GSDs allow interim analyses and potential early stopping for efficacy or futility based on accumulating data. In designing these trials, adaptations for sample size, timing, and number of interim analyses on the accumulated data are common. In recent years, simulation-guided designs are fast becoming the norm in GSDs. They enable sponsors to evaluate a broader range of trial design options before locking in a final trial design, stage analyses at critical interim points, optimize resource allocation, and improve hypothesis generation.

We welcome posters on the topic of patient reported outcomes or other topics in biopharmaceutical statistics. If interested in presenting a poster, please send the title to dirk.moore@rutgers.edu by Thursday, June 5.

For general questions about the symposium, contact the Symposium Organizing Committee Chair, CV Damaraju: cdamara1@its.jnj.com or Stephanie Pugh (American College of Radiology): spugh@acr.org

For registration questions contact Dirk Moore: dirk.moore@rutgers.edu

Venue (note that there is no option for remote attendance):

Rutgers Medical School Kessler Teaching Labs, Main Auditorium

675 Hoes Lane West, Piscataway, NJ 08854

Advance registration closes on Monday, June 9 at 11:30 AM. Late registration at the door is $20.00 extra.

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Speakers:

Susan Ellenberg, PhD, University of Pennsylvania

Practical difficulties faced by DMC/DSMB members in interim monitoring of

industry-sponsored trials

Krishna Padmanabhan, PhD, Cytel

Adaptive Pivotal Trial Designs using Multiple Hierarchical Endpoints (FS Statistics

and Win ratio): A practical example

Liangcai Zhang, PhD, Johnson & Johnson Innovative Medicine

Navigating Complexity: Joint Modeling of Multiple Longitudinal Endpoints and

Simulation-Guided Adaptive Designs in Clinical Trials

Ming-Dauh Wang, PhD, Bayer Pharmaceuticals

Title: Bayesian interim analysis and sample size re-estimation of clinical trials