TITLE: Experiences in Designing and Analyzing Vaccine Outcome Studies
INSTRUCTOR: Scott Patterson (Sanofi Pasteur)
MODERATOR: Dr. Alfred H. Balch
How does one describe the statistics and the role of a statistician in a vaccine outcome (or pivotal) clinical trial? It can be described as a sustained multi-year effort containing long times of shear boredom, meticulous attention to detail, and exhaustive paperwork interspersed with moments of extreme, frantic, concentrated activity requiring a great deal of statistical experience and expertise. Whether the outcome of the vaccine pivotal study is positive, negative, or questionable, there is no experience quite like it.
This session will cover statistical aspects of study design and sample sizing, analysis planning, and interpretation of vaccine clinical outcome data using published examples from the speaker’s experiences pertaining to pivotal vaccine:
– Immunogenicity studies (e.g., Pediatrics 2010; 126: e493-e505),
– Carriage studies (e.g., Clinical Infectious Diseases 2013; 57: 952-962), and
– Clinical Efficacy studies (e.g., NEJM 2015; 372: 1114-25 and Trials in Vaccinology 2016; 5: 92-96).
This session will provide attendees with a wide range of examples with SAS code (including in particular the use of simulation in sample sizing) and cover applications of statistics in vaccine outcome studies, with emphasis upon acceptance of methods relative to emerging regulatory guidance on multiplicity, adaptive designs, and vaccine clinical development.
Scott Patterson, Ph.D., PStat® is currently the Senior Director and Head of Statistical Innovation at Sanofi Pasteur. He is an expert on the design and statistical analysis of clinical and clinical pharmacology trials and has over 25 years of statistical consulting and collaborative experience. Dr. Patterson and Professor Byron Jones co-authored the textbook Bioequivalence and Statistics in Clinical Pharmacology, now in its second edition.