Stats Society Talk: Carlin -- Assessing the risk of a rare adverse outcome following rotavirus vaccination: a case study in biostatistical methods and collaborative engagement

We have a second Stats Society talk this month, this time at UTS. 

Details are below.

Cheers,

Michael


===================

6:00pm - 6.30pm: Refreshments

6:30pm - 7.30pm: Lecture

7:30pm - 8:00pm: Dinner



Venue:

The University of Technology Sydney, Building 2, Level 4, Room 23, Room
2.4.23, Corner of Harris St. & Thomas St., Ultimo, NSW 2007.

 
Professor John Carlin



Murdoch Children’s Research Institute & The University of Melbourne



Assessing the risk of a rare adverse outcome following rotavirus
vaccination: a case study in biostatistical methods and collaborative
engagement



Rotavirus infection is the leading cause of gastroenteritis in young
children: worldwide it is estimated to cause 200,000 deaths and 10 million
episodes of severe diarrhoea annually. The development of vaccines for this
infection suffered a major setback in 1999 when the first licensed vaccine
was withdrawn after it was linked with a substantially elevated risk of
intussusception, a rare acute bowel obstruction that can have fatal
consequences if not treated promptly. Since the mid-2000s, two
second-generation vaccines have been introduced to many national
immunisation programs following large-scale clinical trials that recruited
infants in sufficiently large numbers to rule out adverse event risks of
similar magnitude to those found with the first vaccine. However,
post-marketing surveillance studies from Brazil, Mexico and Australia
suggested that there might be risks with both of the new vaccines, at much
lower levels than with the first vaccine. Given that any level of incidence
of adverse events following vaccination is of major concern, the
Therapeutic Goods Administration (TGA) commissioned us to lead a national
study to assess the risk of intussusception associated with the two
vaccines in Australia. Close collaboration with clinical experts was
essential to this study but ultimately the main challenges were the
ascertainment of good data and careful statistical analysis using both a
self-controlled case series method and the more familiar case-control
method. The self-controlled method relies on conditional likelihood
inference and is challenging to understand intuitively and so to
communicate effectively. The talk will provide an account of this project
and of some lessons that may be drawn for effective biostatistical
practice. I will also give an overview of the Victorian Centre for
Biostatistics, an NHMRC-funded Centre of Research Excellence that aims to
train biostatisticians at doctoral and postdoctoral level within the
framework of a “methodological and translational pipeline”, extending
from the discovery and evaluation of new methods to collaboration and
consultation on a wide range of health problems.


Biography of Professor John Carlin

John Carlin has a national and international reputation in biostatistics,
the science of developing and applying statistical methods to problems in
health and medical research. This field is increasingly recognised as
fundamental to modern research because of rapidly increasing technological
capacity to accumulate and manipulate complex numerical data, in the face
of which deep understanding of the theory and application of statistical
methods has become ever more important. After completing a PhD in
Statistics at Harvard University, John began a career in medical and public
health research. As Director of the Clinical Epidemiology and Biostatistics
Unit at the MCRI and Royal Children’s Hospital, he has played a central
role in developing one of Australia’s leading biostatistical centres. This
Unit has developed a broad program of work, encompassing basic training in
clinical research methods, collaborative contributions to a wide range of
clinical and population health research, with a growing focus on paediatric
clinical trials, and its own methodological research program. In addition
to his role at MCRI, John has a professorial appointment in the Centre for
Epidemiology and Biostatistics, School of Population & Global Health,
University of Melbourne. His international standing in the core discipline
of statistics is attested by co-authorship of an influential graduate-level
textbook with colleagues from Harvard University (Bayesian Data Analysis,
2nd edition 2003). He has over 300 scientific publications across a wide
range of topics in statistical methodology and in numerous substantive
clinical and public health areas.