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Activity Number: 118
Type: Topic Contributed
Date/Time: Monday, August 10, 2015 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #315438 View Presentation
Title: Statistical Challenges for Evaluating Malaria Vaccine Efficacy
Author(s): Ghideon Solomon*
Companies: FDA/CBER
Keywords: Malaria ; Vaccine Efficacy ; Endpoints ; Vaccine clinical trial
Abstract:

Malaria is a major public health problem. An effective vaccine against malaria is actively being sought and is yet to be developed. There has been much debate about the appropriate statistical methodology for the evaluation of malaria vaccine efficacy. In this presentation challenges that include selection of endpoints (first episode vs. multiple episodes), statistical design and model to use (for example: Cox regression, a model based on relative risk), interpretations (for example: Challenges in interpretation of time to event analysis and duration of efficacy for malaria) will be discussed.

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

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