|
Activity Number:
|
381
|
|
Type:
|
Contributed
|
|
Date/Time:
|
Wednesday, August 9, 2006 : 8:30 AM to 10:20 AM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #306085 |
|
Title:
|
Time to Rescue as a Surrogate Endpoint for Analgesic Efficacy in Acute Pain Studies
|
|
Author(s):
|
Julia Wang*+ and Akiko Okamoto and Surya Mohanty
|
|
Companies:
|
Johnson & Johnson Pharmaceutical R&D and Johnson & Johnson Pharmaceutical R&D and Johnson & Johnson Pharmaceutical R&D
|
|
Address:
|
920 Route 202, S., Raritan, NJ, 08869,
|
|
Keywords:
|
surrogate endpoints ; analgesic trials ; Prentice's criteria ; proportion of treatment effect explained
|
|
Abstract:
|
In controlled clinical trials involving acute pain, efficacy variables such as pain relief/intensity scores are collected longitudinally. The time course of these variables is vital for understanding analgesic effect of the test compound. However, subjects often require rescue with a supplemental analgesic medication, making it hard to characterize the analgesic activity of the new compound. We propose that the "time to rescue medication" be adopted as a primary endpoint in place of the conventional primary endpoints derived from the longitudinally collected pain relief/intensity scores by demonstrating the former to be a surrogate of the later. Validation of the proposed surrogacy will be demonstrated through various statistical methods, including graphical techniques and Prentice's criteria. Estimates of proportion of treatment effect explained by the surrogate will be provided.
|
