|
Activity Number:
|
102
|
|
Type:
|
Topic Contributed
|
|
Date/Time:
|
Monday, August 3, 2009 : 8:30 AM to 10:20 AM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #304411 |
|
Title:
|
Simulating Drug Supply for Adaptive Trials
|
|
Author(s):
|
Nitin R. Patel*+
|
|
Companies:
|
Cytel, Inc.
|
|
Address:
|
675 Massachusetts Avenue, Cambridge, MA, 02138,
|
|
Keywords:
|
adaptive ; drug supply ; simulation ; clinical trials
|
|
Abstract:
|
The cost and feasibility of drug supply for a clinical trial with an adaptive design is often a concern. The adaptive aspect of the design increases uncertainty because the demand for a particular dose is not known in advance but evolves dynamically as the trial progresses and responses of subjects to various treatments are observed. This is in contrast to non-adaptive designs where the total number of subjects to be allocated to each treatment is fixed. The task of simultaneously assessing the impact of uncertainties due to randomness in enrolment at multiple sites, shipping delays, and packaging strategies as well as adaptive dose allocation requires simulation software. We will use examples based on consulting projects to illustrate how such a simulation tool can be used to develop efficient drug supply plans for adaptive trials.
|
- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
Back to the full JSM 2009 program |
