Governance Flowchart 05OCT2021

ASCOT International Trial Steering Committee (ITSC)

The ITSC includes clinical trialist, biostatisticians, regional lead investigators, domain led investigators and project managers

 Asha Bowen (Chair) Joshua Davis Naomi Hammond
Bala Venkatesh Justin Denholm Steven Tong
David Paterson Matthew O'Sullivan Susan Morpeth
David Price Megan Rees Tom Snelling
Jason Roberts Nanette Trask Vivekanand Jha 
Zoe McQuilten Bhupendra Basnet


ASCOT Sponsorship Committee

The board is responsible for monitoring quality control of the data, progress of recruitment and safety aspects of the trial.

Mark Rosenthal (Chair) Sarah Rickard Sharon Lewin
Andrea Fischer Mark Hargreaves Steven Tong
David Paterson Mark Sullivan


Data and Safety Monitoring Board (DSMB)

The board is responsible for monitoring quality control of the data, progress of recruitment and safety aspects of the trial.

Anthony Kelleher (Chair) Anne Chang David Price
Lorenza Trippa Ralph Stewart Prakash Ghimire
Thomas Jaki James Totterdell


Statistical Committee

The Statistical Committee is responsible for the development of the statistical analysis plan and provides recommendations for the analysis of the outcome data.

Tom Snelling (Co-Chair) Justin Denholm Ian Marschner
David Price (Co-Chair) Julie Marsh James McGree
Steven Tong Mark Jones Gian Luca Di Tanna
Joshua Davis Tim Spelman


Biobanking Steering Committee (ABC)

The ABC oversees sample collection, storage and applications for sample access related to biological research undertaken in ASCOT.

Justin Denholm (Chair) Priyanka Pillai Paula Ellenberg
David Paterson Vi Nguyen Mahesh Moorthy
Gagandeep (Cherry) Kang James McFadyen Susan Morpeth
Edward Raby Jason Roberts Katie Flanagan
Craig Gedye Damian Purcell Judy Chang
Michael Maze


Pregnancy Working Group

The pregnancy working group oversees the development of pregnancy specific eligibility criteria and data collection for the ASCOT ADAPT protocol.

Megan Rees (Co-Chair) Asha Bowen Sourabh Dutta
Clare Whitehead (Co-Chair) Adrienne Gordon
Susan Walker Michelle Giles


Domain-Specific Working Group (Antiviral, Antibody, Anticoagulation)

There will be a DSWG for each active and future planned domain. The DSWGs will be responsible for monitoring the current and potential interventions within a domain.


Susan Morpeth (Co-Chair) Tom Hills Megan Rees
Bala Venkatesh (Co-Chair) David Paterson Sharon Lewin
Steven Tong Jason Roberts Gagandeep (Cherry) Kang
Joshua Davis Greg Dore


Zoe McQuilten (Co-chair) Erica Wood Susan Morpeth
Matthew O'Sullivan (Co-chair) James Daly Veronica Hoad
Steven Tong Iain Gosbell Tom Hills
Richard Charlewood Aikaj Jindal Kristina Kairaitis


Zoe McQuilten (Co-chair) Sanjeev Chunilal Eileen Merriman
Jason Roberts (Co-chair) James McFadyen Jennifer Curnow
Huyen Tran Robert Medcalf Joseph John


Region-Specific Working Groups

The RSWGs are responsible for identification and management of sites and study documents within that region.


Justin Denholm (Co-chair) Jane Davies Nigel Raymond
Susan Morpeth (Co-chair) Naomi Knoblauch Eamon Duffy
Michael Maze Jack Dummer Lou Irving
Emily Rowe Peter Wark Andrew Burke
Alison Ratcliff Sandra Hodge James Molton


 India and Nepal

Gagandeep Kang (Co-Chair) Naomi Hammond Oommen John
Vivek Jha (Co-Chair) Bala Venkatesh Mahesh Moorthy
Dipak Haksar Steven Tong Zoe McQuilten
Aikaj Jindal Susan Morpeth Joseph John
Abhinav Bassi Baldeep Kaur Suman Pant
Santa Kumar Das Ashesh Dhungana Purnima Rao Jevaji


Sub-Study Committees

The sub study committees will review any proposals for additional studies to the main protocol, designed to ask a separate research question and initiate new data collection from the trial participants.


The Analytic Team

The analytic team is responsible for the conduct of the planned interim analyses by running the predetermined statistical models and providing the output to the DSMB.


Regional hubs

NT, SA, TAS, VIC, WA: The Peter Doherty Institute for Infection and Immunity (The Doherty)

ACT, NSW: Hunter Medical Research Institute (HMRI)

QLD: University of Queensland Centre for Clinical Research (UQCCR)

India and Nepal: The George Institute (TGI)

New Zealand: Middlemore Clinical Trials (MMCT)

Denmark: Centre of Research & Disruption of Infectious Diseases (CREDID)