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 ZGlyayAhIG1vb3JlIHwgcnV0Z2VycyAhIGVkdQ== by Thursday, June 5.

For general questions about the symposium, contact the Symposium Organizing Committee Chair, CV Damaraju: Y2RhbWFyYTEgfCBpdHMgISBqbmogISBjb20= or Stephanie Pugh (American College of Radiology): c3B1Z2ggfCBhY3IgISBvcmc=

For registration questions contact Dirk Moore: ZGlyayAhIG1vb3JlIHwgcnV0Z2VycyAhIGVkdQ==

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.

Travel notes: Parking is free. Please park in Lot C if space is available or in Lot A across the street. Do not park in reserved spots.

We recommend that you set your GPS to "683 Hoes Lane West, Piscataway, NJ". This will take you to the entrance to Lot C. The entrance to Lot A is directly across the street.

Failure to do this may result in a traffic citation. (Campus police verify registration by scanning license plates.)

parking registration link:

Challenges with the Use of Interim Analyses in Clinical Trials

[Rutgers faculty and staff with parking privileges may not use this link.]

Travel by train: NJ Transit Northeast Corridor to Edison or

New Brunswick. Take a taxi or other ride share to the venue.

Rutgers University-New Brunswick Student Centers encourages qualified persons with disabilities to participate in its programs and activities. If you anticipate needing any type of accommodation or have questions about the physical access provided at the Student Centers, please contact the Meetings and Events Office in advance of your participation or visit. The Meetings and Events Office may be reached at 848.932.8821 or via email at Y2VudGVycmVzIHwgZWNobyAhIHJ1dGdlcnMgISBlZHU=.

Speakers:

Susan Ellenberg, PhD, University of Pennsylvania

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

industry-sponsored trials

CG Wang, PhD, Regeneron

Multiplicity Control in Oncology Clinical Trials with a Surrogate Endpoint-Based Drop-The-Losers Design

Ming-Dauh Wang, PhD, Bayer Pharmaceuticals

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

Liangcai Zhang, PhD, Johnson & Johnson Innovative Medicine

Navigating Complexity: Joint Modeling of Multiple Longitudinal Endpoints and

Simulation-Guided Adaptive Designs in Clinical Trials

Krishna Padmanabhan, PhD, Cytel

Adaptive Pivotal Trial Designs using Multiple Hierarchical Endpoints (FS Statistics

and Win ratio): A practical example

Also check out other Meetups in Piscataway.