Online Program Home
My Program

Abstract Details

Activity Number: 483 - Multiplicity
Type: Contributed
Date/Time: Wednesday, August 1, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #328480
Title: Controlling the Family-Wise Type I Error Rate in a Phase II POC Trial of the Merck Pneumococcal Vaccine Program: An Application of the Hochberg Approach
Author(s): Jianing Li*
Companies: Merck Research Lab
Keywords: Hochberg Approach; Multiplicity; Pneumococcal Vaccine

In the late stage vaccine development, it is common that more than one formulation is proposed in the Phase II proof-of-concepts (POC) trial. These proposed formulations generally have the equal level of importance and will all be considered as primary endpoints, therefore multiplicity needs to be adjusted for the multiple primary endpoints. The Hochberg Approach is a popular approach to control the family-wise Type I Error Rate under this scenario. In the presentation, we will first briefly explain why the Hochberg approach is preferable to other approaches. Then, we will illustrate the application of the Hochberg approach in a Phase II POC Trial of the Merck Pneumococcal Vaccine Program and evaluate how this will impact the formulation selection before proceeding to Phase III trials.

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

Back to the full JSM 2018 program