Governance

Governance

Trial sponsor

University of Newcastle

ROADMAP Trial coordinating sponsor is the University of Newcastle, NSW Australia with each participating country having a regional sponsor, regional coordinating centre and regional Trial Steering Committee (TSC) and working groups. The overarching coordinating centre is the University of Newcastle located at the Hunter Medical Research Institute (HMRI).

Global Trial Management Group (TMG)

Global Trial Management Group

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Professor Joshua Davis
Chief Investigator

Professor Laurens Manning
Co-Chief Investigator

Dr Marline Squance
Global Clinical Trial Manager

Jessica Massie
Data Manager/Coordinator

Hanah Hart
Isolate Repository Coordinator

Sandy Isles
Administrative Assistant

Mia Di Virgilio
‍Clinical Trial Coordinator & Monitor (Australia)

Alana Di Giacomo
Clinical Trial Coordinator & Monitor (Australia)

Alexandra Mowday
Clinical Trial Project Manager
(New Zealand)

Georgia Fowler
Clinical Trial Coordinator
(New Zealand)

Global Trial Steering Committee (GTSC)

The GTSC is responsible for the overall decision making related to the trial including the strategic direction and operational structure of the trial including setting research questions, protocol and domain development, the inclusion of any trial related sub-studies, the research data analysis and final reporting of research findings including publication oversight.

The membership of the GTSC consists of lead representatives from infectious disease and orthopaedic surgical disciplines from each participating country, as well as experts in adaptive trials, statistics, microbiology, chairs of trial working groups, a consumer PJI expert and the Global project manager.

Global Trial Steering Committee

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Coordinating Principal Investigators & Co-Chairs:

Professor Joshua Davis

Professor Laurens Manning

Chief Investigators:

Professor Richard de Steiger ‍

Professor Steven Y.C. Tong

Dr Thomas Hills

Mr. Geoffrey Strong

Associate Professor Trisha Peel

‍Professor Tom Snelling

Associate Professor Nick Daneman

Associate Professor Stefano Giulieri

Dr Marline Squance

Professor Ian Harris

‍Associate Professor David Dewar

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‍Professor James Howard

‍Associate Professor Christopher Jones

Associate Professor David Campbell

Associate Professor Simon Young

Data Safety and Monitoring Committee (DSMC)

The DSMC membership is independent of steering committees, working groups and any sponsor Institute of the trial. The DMSC has the role of monitoring the safety and efficacy of the trial including patient safety and quality control of data as well as recruitment and the application of trial specific adaptive platform rules which have been set at the commencement of the trial. The DSMC, advise trial committees on all these areas of the trial.

The DSMC is composed of clinician and research members that are knowledgeable in the fields of prosthetic joint infections (PJI), surgical treatment of PJI, adaptive platform research trials, the pharmacological treatment of PJI, and research statistics.

We are currently working on finalising the membership of this group.

Data Safety and Management Committee

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Chair:

Roger Lewis

Members:

Nicolas Cortes-Penfield

Nicolas Piuzzi

Gerard Slobogean

Sandra Nelson

Regional Trial Steering Committees

Australia

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Chair:

Dr Paul Chapman

Members:

Professor Joshua Davis‍

Professor Laurens Manning‍

Professor Steven Y.C. Tong

Professor Piers Yates

Associate Professor Renjy Nelson
Yasser Khatib
Zhenya Welyczko

New Zealand - TBA

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Co-Chairs:

Dr Thomas Hills

Associate Professor Simon Young

Members:

Dr Mei Lin Tay

Dr Christopher Luey

Dr Alexandra Mowday

Ms Georgia Fowler

Mr John Mutu-Grigg

Canada - TBA

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Co-Chairs:

Associate Professor Nick Daneman

Dr Christopher Kandel

Members

Dr Jennie Johnstone

Dr Marisa Ann Azad

Dr Terence Wuerz

Dr Peter Daley
Dr Adam Hart
Tracey MacCharles

Dr Jesse Wolfstadt
Dr Jason Werle

Dr James Howard
Dr Elissa Rennert-May

United Kingdom - TBA

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Chair:

TBA

Members:

TBA

Antibiotic Working Group

Antibiotic Working Group

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1. Antibiotic Duration

Chair:

Professor Laurens Manning
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Members:

Professor Joshua Davis

Professor Owen Robinson

Associate Professor Nick Daneman

Associate Professor Renjy Nelson

Associate Professor Stefano Giulieri

Professor Richard de Steiger

Dr Paul Chapman

Dr Christopher Luey

Dr Thomas Hills

Dr Christopher Kandel

Dr Jennie Johnstone

Associate Professor Archana Sud

Dr Ravi Dotel

Professor Trisha Peel

Professor Eugene Athan OAM

Kelly Cairns

Dr Jesse Wolfstadt

2. Antibiotic Choice

Co-Chairs:

Professor Trisha Peel

Professor Joshua Davis

Members:

Professor Laurens Manning

Professor Owen Robinson

Associate Professor Nick Daneman

Associate Professor Stefano Giulieri

Professor Richard de Steiger

Dr Christopher Luey

Dr Thomas Hills

Dr Jesse Wolfstadt

Dr Jennie Johnstone

Associate Professor Archana Sud

Associate Professor Renjy Nelson

Dr Christopher Kandel

Dr Paul Chapman

Dr Ravi Dotel

Professor Eugene Athan OAM

Kelly Cairns

Surgical Working Group

Surgical Working Group

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Co-Chairs:

Associate Professor David Dewar

Associate Professor Simon Young

Members:

Professor Joshua Davis

Associate Professor David Campbell

Professor Ian Harris

Professor James Howard

Dr Roseanna Hoswell

Professor Laurens Manning

Associate Professor Craig Aboltins

Professor Richard de Steiger

Dr Thomas Bucher

Andrew Fraval

Associate Professor Christopher Jones

Bertrand Boyer

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Registry Working Group

Registry Working Group

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Chair:

Associate Professor David Campbell

Members:

Professor Joshua Davis

Professor Laurens Manning

Associate Professor David Dewar

Professor Mike Reed

Associate Professor Gavin Wood

Associate Professor Simon Young

Professor Richard de Steiger

Professor Steven Y.C. Tong

Statistics Working Group

Statistics Working Group

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Chair:

Professor Tom Snelling
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Members:

Professor Joshua Davis

Professor Laurens Manning

Dr Marline Squance

Jessica Massie

Associate Professor Chris Oldmeadow

Dr Daniel Barker

Daniela Vargas

James Totterdell

Mark Jones

Professor Steve Webb

Analytic Group

Analytic Group

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Chair:

TBA

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Members:

TBA

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Health Economics Group

Health Economics Group

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Chair:

Dr Victoria McCreanor

Members:

Professor Joshua Davis

Professor Laurens Manning

Microbiology Working Group

Microbiology Working Group

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Chair:

Associate Professor Stefano Giulieri

Members:

Professor Joshua Davis

Professor Laurens Manning

Dr Bernadette Young

Dr Marline Squance

Stéphane Corvec

Susan Morpeth

Consumer Reference Group

Consumer Reference Group

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Chair:

Tracey Cotter

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Members:

TBA

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ABOUT

ROADMAP Team

ROADMAP is supported by a number of key personnel in a global trial management group (TMG) as well as a global trial steering committee (GTSC), regional trial management groups from each participating country, and ROADMAP specialist working groups. Together they all guide the study to meet its research goals with scientific validity, safety and with a focus on improving health outcomes for people that experience prosthetic joint infections.

PJI investigators