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 sanhita.sengupta@bms.com 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.
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.
You must register your vehicle and license number in advance at this web address:
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.
Information for Persons with Disabilities
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 centerres@echo.rutgers.edu.
Program:
8:30 - 9:00
 Registration and breakfast
9:00 - 9:05
 Opening remarks
9:05 - 10:00 CG Wang, PhD, Regeneron
Multiplicity Control in Oncology Clinical Trials with a Surrogate Endpoint-Based Drop-The-Losers Design
10:00 - 10:55 Ming-Dauh Wang, PhD, Bayer Pharmaceuticals
Title: Bayesian interim analysis and sample size re-estimation of clinical trials
10:55 - 11:15 Break / Posters
11:15 - 12:10 Liangcai Zhang, PhD, Johnson & Johnson Innovative Medicine
Navigating Complexity: Joint Modeling of Multiple Longitudinal Endpoints and
Simulation-Guided Adaptive Designs in Clinical Trials
12:10 - 1:10 Lunch
1:10 - 2:05 Susan Ellenberg, PhD, University of Pennsylvania
Practical difficulties faced by DMC/DSMB members in interim monitoring of
industry-sponsored trials
2:05 - 3:00 Krishna Padmanabhan, PhD, Cytel
Adaptive Pivotal Trial Designs using Multiple Hierarchical Endpoints (FS Statistics
and Win ratio): A practical example
3:00 - 3:10   
Coffee break
3:10 - 3:30
  
Panel Discusion
Moderator: CV Damaraju, Treasurer of ASA New Jersey Chapter
3:30   Closing remarks
Revathi Ananthakrishnan, ASA Princeton-Trenton Chapter
Information Source: New Jersey and Princeton-Trenton Chapters ASA | eventbrite

Middlesex County

United States

Piscataway

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