Activity Number:
|
568
- Simulation Report for Designing Adaptive Clinical Trials: Current Practices and Recommendations to Industry
|
Type:
|
Topic Contributed
|
Date/Time:
|
Wednesday, August 2, 2017 : 2:00 PM to 3:50 PM
|
Sponsor:
|
Biopharmaceutical Section
|
Abstract #322820
|
View Presentation
|
Title:
|
Current Practices in Reporting Trial Simulations for Adaptive Study Designs
|
Author(s):
|
cristiana mayer* and Parvin Fardipour
|
Companies:
|
Janssen R&D and ICON
|
Keywords:
|
simulations ;
simulation report ;
adaptive trial design
|
Abstract:
|
This talk will provide an overview of key components in conducting and documenting simulations in the context of designing adaptive clinical trials. The talk will touch upon both the general framework of the simulation report and the ultimate goal of eliminating unnecessary barriers in communicating to different audiences the operating characteristics associated to alternative study designs. A group of statisticians from industry and the FDA came together within the DIA Adaptive Design Scientific Working Group to work on the best practices and recommendations around simulation conduct and reporting in various settings of the most frequently used adaptive clinical trial designs. When adaptive designs are an integral part of a compound development program, the simulation report is to be regarded as a regulatory document. As stated in the 2010 FDA guidance on adaptive designs, detailed documentation on the simulation report and results should accompany the study protocol. Specific references will be made to the objectives and structure of the simulation report and how they link to the different goals and types of audiences that such report needs to address.
|
Authors who are presenting talks have a * after their name.