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Activity Number: 162 - Statistical Challenge and Issues in Vaccine Development
Type: Topic Contributed
Date/Time: Monday, July 30, 2018 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section
Abstract #330857
Title: Recent Challenges in Vaccine Clinical Development
Author(s): Tsai-Lien Lin*
Companies: FDA/CBER
Keywords: Vaccine; Clinical trial

Many new vaccines have been and are being developed over the recent years; for example, vaccines for protection against unpredictable emerging diseases or diseases that still have no vaccine available, vaccines with novel adjuvant that offer special advantages over existing vaccines, vaccines for preventing recurrence of diseases, and vaccines delivered through maternal immunization for protecting infants. Different vaccines face different challenges in study design and analysis due to disease nature, ethical considerations, and regulatory considerations. This presentation will provide an overview of some challenges encountered and lessons learned from real examples.

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

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