JSM 2015 Online Program

Online Program Home
My Program

Abstract Details

Activity Number: 577
Type: Invited
Date/Time: Wednesday, August 12, 2015 : 2:00 PM to 3:50 PM
Sponsor: ENAR
Abstract #314240 View Presentation
Title: Design Consideration for High Dropout Problem in Psychiatric Trials
Author(s): Jinglin Zhong* and Peiling Yang and Ni A. Khin and H.M. James Hung
Companies: FDA and FDA and FDA and FDA
Keywords: high dropout rate ; psychiatric trials ; major depressive disorder ; clinical trial design considerations

High dropout rate is a widely known problem in psychiatric trials. The average dropout rate is about 33% for Major Depressive Disorder trials and 45% for Schizophrenia trials. The high dropout rate weakens the reliability of analysis results and jeopardizes the statistical inference even if the primary analysis result is statistically significant. To address this issue, we conducted analyses to explore two design approaches based on our aggregated patient-level efficacy data from 41 randomized, double-blind, and short term clinical trials in Major Depressive Disorder. Our findings from evaluation of these two design approaches will be presented. The pros and cons of each of these approaches will also be discussed.

Authors who are presenting talks have a * after their name.

Back to the full JSM 2015 program

For program information, contact the JSM Registration Department or phone (888) 231-3473.

For Professional Development information, contact the Education Department.

The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.

2015 JSM Online Program Home