Melbourne Centre for Clinical Trials (MCCT)
At the Melbourne Centre for Clinical Trials (MCCT), we bring together a consortium of world class clinical trial groups to deliver exceptional trials. What truly sets us apart is our commitment to maintaining the unique identity and business operations of each of our valued members. Professor Jane Gunn, Interim Provost
Who We Are
Make a global impact
MCCT has world-leading clinical trial experts, ensuring top-tier research and medical innovation.
Adaptive Platform Trials
The MCCT houses seven of Australia’s largest adaptive platform trials.
The Consortium
The MCCT is a collaborative powerhouse, uniting top-tier research institutions and experts and setting a benchmark in its field for scale and expertise.
Expertise and resource network
Provides a point of access to expertise and resources within The University of Melbourne and Melbourne Academic Centre of Health (MACH) clinical trials community by leveraging collective knowledge and diverse skills.
Our Purpose
The primary purpose of the MCCT is to facilitate best practices in the conduct of clinical trials, supporting stakeholders through collaboration with the MCCT. Providing access to a collaborative network and extensive resources that streamline and elevate every stage of clinical trial execution. At MCCT, innovation merges with efficiency to advance healthcare and medical research.
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- Strengthen the collaborative clinical research sector by connecting clinical researchers and methodology experts involved in the design and implementation of clinical trials.
- Improve quality assurance and compliance with systems by collating and maintaining a central resource of standardized operating procedures (SOPs) for the conduct of clinical trials, including protocol development, participant recruitment and safety, data management, and regulatory compliance.
- Streamline communication and dissemination of the review and approval processes for clinical trial protocols by relevant ethics committees and regulatory authorities.
- Promote the MCCT consortium partners and their events, short courses, and clinical trials education to support the development and training of staff involved in clinical trial activities, ensuring compliance with applicable regulations and guidelines.
- Facilitate collaboration with external partners, including industry sponsors (pharmaceutical companies and biotech firms), contract research organizations (CROs), and other research institutions, to enhance MCCT members capacity for conducting clinical trials.
Prof Julie Simpson
Methodology Director
Methodology Director Prof Julie Simpson (FAHMS) has >30 years experience as a biostatistician contributing to clinical and population health research. Previously she has worked at St Thomas's Hospital, London, Mahidol-Oxford Research Programme in Thailand, University of Aberdeen, and Cancer Council of Victoria. Her main research areas are: the integration of biostatistics and mathematical modelling to improve the control of infectious diseases and statistical methods for handling missing data. Julie is Head of the Biostatistics Unit, Melbourne School of Population and Global Health, Director of the Methods and Implementation Support for Clinical and Health research Hub and recipient of NHMRC Investigator Grants (Leadership L1, 2021-5; L2, 2026-30).
Prof Adam Deane
Clinical Director
Professor Adam Deane is an internationally recognised intensive care physician and leading critical care researcher. He trained in Intensive Care Medicine and Internal Medicine in Melbourne, Adelaide and Oxford (UK). Adam’s research focuses on clinical trials and outcomes following critical illness. He is Deputy Director and Head of Research at the Intensive Care Unit at The Royal Melbourne Hospital. At the University of Melbourne, he serves as Deputy Head of the Department of Critical Care, leads the Intensive Care Medicine stream, and is Clinical Lead for the MISCH Clinical Trials Node. Adam is a recipient of a National Health and Medical Research Council (NHMRC) Investigator Grant (Leadership Level 1).
Prof Steven Tong
Head of Adaptive Platform Trials
Professor Steven Tong is an infectious diseases physician with the Victorian Infectious Diseases Service and Co‑Head of the Clinical and Health Services Research division at the Doherty Institute. He leads large‑scale global clinical trials for common infectious diseases and holds leadership roles across multiple adaptive platform trials, including as lead of the Staphylococcus aureus Network Adaptive Platform (SNAP) trial and the Australasian COVID‑19 Trial (ASCOT). Steven’s research achievements include the discovery and naming of two new Staphylococcus species, identification of a novel hepatitis B genotype in Indigenous Australians, and the conduct of landmark clinical trials in MRSA bloodstream infections, COVID‑19 and impetigo, enrolling more than 5,000 patients with Staphylococcus aureus bloodstream infections. His research interests span skin and hospital pathogens, Indigenous health, viral hepatitis and influenza, with a strong focus on applying cutting‑edge science to clinically driven questions.
Renata Phyland
Clinical Trials Manager
Renata Phyland is the Clinical Trials Manager for the Melbourne Academic Centre for Health (MACH) and the Melbourne Centre for Clinical Trials (MCCT) network. She holds a Bachelor of Science (Honours) from the University of Melbourne. Renata has extensive experience in clinical trial governance and ethics across a wide range of therapeutic areas. She leads initiatives that streamline trial processes and improve regulatory compliance while fostering collaboration across institutions. Renata enjoys working closely with a variety of stakeholders to find practical solutions that meet everyone’s needs. Her work supports high quality patient centred research across Victoria and contributes to national efforts that enhance clinical trial efficiency and innovation.
Latest MCCT News
MCCT is the pre-eminent centre for clinical trials and the largest consortium of its kind in Australia. Operating under the oversight of The University of Melbourne and affiliated Melbourne Academic Centre for Health (MACH) hospitals and institutes. It is comprised of 13 clinical trials units and 2 methodology groups:
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Austin Hospital, Clinical Trials Unit
Austin Health comprises the Austin Hospital, Heidelberg Repatriation Hospital and the Royal Talbot Rehabilitation Centre. The Austin Clinical Trials Unit currently conducts trials investigating cancer, dementia, and antenatal depression treatment.
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Centre for Eye Research Australia Clinical Trials Unit
Cerulea delivers ophthalmic clinical trials for Australian and international biopharmaceutical and medtech companies, and is the home of investigator-initiated studies for the Centre for Eye Research Australia. Explore our list of current trials at Cerulea and CERA.
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Doherty Clinical Trials
The Peter Doherty Institute for Infection and Immunity has established Doherty Clinical Trials Ltd to deliver early phase studies for local and global clients.
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Methods and Implementation Support for Clinical and Health (MISCH) Research Hub
MISCH provides expertise in research methods to ensure high quality and impactful clinical and health research. This collaborative platform includes experts in the research methods - Biostatistics, Clinical Epidemiology, Health Economics, Health Informatics (REDCap), and Co-Design and Consumer Involvement.
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Northern Hospital, Clinical Trials Unit
Northern Health is the major provider of acute, sub-acute and ambulatory specialist services in Melbourne's north.
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Parkville Cancer Clinical Trials Unit at Peter MacCallum Cancer Centre
The Parkville Cancer Clinical Trials Unit, Australia's largest cancer clinical trials unit, was established in 2016, from the cancer clinical trials units of Peter Mac, Royal Melbourne and the Women’s. With 10 cancer stream teams specialising in haematology, solid cancers, theranostics and palliative care and specialised experience and expertise in first in human and complex clinical trials.
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Melbourne Children's Trials Centre @ MCRI
The Melbourne Children’s Trials Centre (MCTC) provides support for clinical trials, ranging from trials of novel therapies to large preventative public health trials. The MCTC is a unique collaboration between the Royal Children’s Hospital, The Murdoch Children’s Research Institute, The Royal Children’s Hospital Foundation and The University of Melbourne.
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Clinical Epidemiology & Biostatistics Unit (CEBU)
The Clinical Epidemiology and Biostatistics Unit (CEBU) specialises in biostatistics, epidemiological methods, and data management. CEBU collaborates with a wide range of clinical and population health researchers and also conduct methodological research, both to develop and strengthen the biostatistical methods underpinning modern health research and to develop future leaders in data science.
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The Royal Melbourne Hospital Clinical Trials Unit
The Royal Melbourne Hospital is recognised as a world renowned institution, not only providing outstanding care and treatment, but improving the outcomes for all through a comprehensive medical research program, and the training of future health professionals. The Clinical Trials Centre (CTC) is a dedicated purpose-built space for conducting clinical trials. All clinical trial visits at the Royal Melbourne Hospital take place in this space.
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St Vincent's Hospital, Melbourne Clinical Trials Unit
St Vincent’s Hospital Melbourne is at the forefront of innovative research making us a premier site for medical research and clinical trials. In 2020, St Vincent’s Health Network, Sydney and Melbourne has been selected as one of the 14 pilot sites for the pilot of the National Clinical Trials Governance Framework.
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Department of General Practice and Primary Care Trials Unit
The Primary Care Trials Unit is a specialised University of Melbourne team of primary care researchers develop and conduct clinical trials with a wide range of collaborators. Our focus is on health services research and implementation science using primary care innovation, clinical data analytics and linkage, and co-design with consumers and practitioners.
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Walter and Eliza Hall Institute of Medical Research
The Walter and Eliza Hall Institute is Australia's oldest medical research institute. WEHI researchers and clinicians are actively involved in clinical studies across a range of disease areas.
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Neuroscience Trials Australia
As part of The Florey Institute of Neuroscience and Mental Health (the largest brain research institute in the southern hemisphere), Neuroscience Trials Australia (NTA) is a global CRO specialising in conducting neuroscience clinical trials.
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The Florey Institute of Neuroscience and Mental Health
The Florey is recognised worldwide for its life-changing discoveries in neuroscience and mental health. Our researchers are investigating how the brain works, what drives behaviour, the underlying causes of diseases, and the connections between the body and the brain. Our work encompasses fundamental scientific discoveries, cutting-edge brain imaging techniques, developing disease biomarkers, developing new treatments, drug screening and taking our work to clinical trial
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Western Health, Clinical Trials Unit
Western Health Cancer Services has been involved in research to discover improved or new treatments for most cancer types for over 20 years. Our unit is a member of the Victorian Comprehensive Cancer Centre and Cancer Trials Australia.
MCCT is proud to be part of a new era in clinical research. We’re helping lead the way with adaptive platform trials. These trials can study several therapies at once and evolve as results come in by dropping what doesn’t work and focusing on what does. That means better care for patients, quicker answers for researchers and more efficient use of resources. It’s an exciting and cutting-edge approach that’s transforming how we improve healthcare.
ASCOT
Is finding fast and effective COVID-19 treatments to reduce deaths and ventilation needs in hospitalised patients before they become critically ill.
Find out more
BANDICOOT
This study tests multiple supportive care approaches in one trial to find what helps children recover best after a stem cell transplant. It aims to improve wellbeing now and build a stronger system for future research.
Find out more
PASSPORT
This study brings multiple sepsis treatments into one trial. It evolves over time to provide the most effective care to the participant.
Find out more
PLATIPUS
Is a world-first clinical trial that aims to improve the health of babies born and at risk of being born prematurely.
Find out more
SEAMLESS
This research tests new stroke treatments by building a national study using a flexible trial design to improve care and outcomes for patients across Australia.
Find out more
SNAP
This international trial is working with both adults and children to find better treatments for serious bloodstream infections caused by Staphylococcus aureus.
Find out more
STRAP
This study tests different treatments for serious strep infections in one trial to find what works best. It aims to improve care and outcomes for people of all ages.
Find out more
Training and Methodological Experts
Australian Clinical Trials Education Centre (A-CTEC)
Provides training regarding clinical trials including good clinical practice (GCP) training.
More informationAustralian Clinical Trials Alliance (ACTA) Resources
Resource for webinars and articles on investigator initiated clinical trials.
More informationThe Methods and Implementation Support for Clinical and Health (MISCH) Hub
A collaborative platform with experts providing expertise in research methods to ensure high quality and impactful clinical and health research.
More informationClinical Epidemiology & Biostatistics (CEBU)
Promote high quality research by partnering with the Melbourne Children’s Campus to provide expert training and resources for clinical and public health researchers at all stages.
More informationHelpful Tools
Clinical Trial Planner
Created by Health Translation Queensland this tool supports trial planning with practical information and guidance.
More informationHealth Data Australia
A national catalogue for Australian health data for researchers to use and register datasets.
More informationLegal Agreement Templates
Medicines Australia Clinical Trial Research Agreements
Clinical Trial Research Agreement (CTRA) templates that are the standard template for use in clinical trials.
More informationMACH Research Collaboration Agreement
Research Collaboration Agreement (RCA) template for use in investigator-initiated non-sponsored projects.
More informationEssential Guidance
Therapeutic Goods Administration (TGA) Clinical Trial Handbook
Guidance on conducting clinical trials in Australia using 'unapproved' therapeutic goods.
More informationNational Statement on Ethical Conduct in Human Research
The National Statement provides a framework to ensure human research in Australia is carried out responsibly.
More informationSafety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods
Defines roles for monitoring and reporting clinical trial safety issues.
More informationmarra ngarrgoo, marra goorri - The Victorian Aboriginal Health, Medical and Wellbeing Research Accord
The vision of marra ngarrgoo, marra goorri is to align research with Aboriginal and Torres Strait Islander principles of self-determination.
More informationStandard Operating Procedures (SOPs) and Templates for University of Melbourne Sponsored Clinical Trials
The below are SOPs and templates for University of Melbourne sponsored clinical trials to ensure that tasks are completed consistently and correctly. Use of these documents is not mandatory. These SOPs and templates have been developed as a resource to support clinical trial teams and reduce the administrative burden where possible.
SOP-02 Delegation of Responsibilities for University of Melbourne Clinical Trials
To describe the procedures and requirements related to the delegation of Sponsor responsibilities from University of Melbourne.
SOP-03 Site Staff Qualifications, Training Records and Capability
Document staff qualifications and site resources to ensure compliance with ICH GCP and governance standards.
SOP-04 Protocol and Investigational Brochure Requirements
Outline procedures for developing research protocol, IB, and amendments ensuring compliance with ICH GCP E6(R2).
SOP-05 Communication with HREC, RGO, Sponsor and Institution’s Insurer
Procedures for communication with HREC, RGO, Sponsor and Insurer regarding research governance requirements.
SOP-06 Site Initiation
To describe the procedures related to site initiation of a clinical trial at all sites.
SOP-07 The Study Master File
To describe the procedures related to the maintenance of the Study Master File (SMF) held at all clinical research sites/units, according to ICH GCP E6 (R2) Section 8 to ensure it is current at all times for the duration of the clinical study.
SOP-08 Case Report Forms and Source Documents
To describe the procedures related to the completion of electronic and paper based Case Report Forms (CRF), and maintenance of Source Documents.
SOP-09 Participant Informed Consent Process and Documentation
Describe procedures and documentation for informed consent including telehealth to ensure voluntary informed decisions through ongoing communication.
SOP-10 Handling and Shipping of Biological Substances (Cat B) and Dangerous Goods
Explain safe handling and shipping of Biological Substances (Cat B) and/or Dangerous Goods and the rules involved.
SOP-11 Management of Investigational Product
Explain how to manage to managing all aspects of Investigational Product (IP) from delivery to preparation, storage and disposal.
SOP-12 Safety Data Monitoring and Reporting Requirements for Clinical Trials
Outline steps for collecting, checking, and reporting safety data in clinical trials.
SOP-13 Site Close-Out and Archiving
To describe the procedures related to close-out of a clinical trial at all sites and archiving of trial related documentation at the end of the clinical trial.
SOP-14 Data Sharing and Access Procedure for the Release of Data from University of Melbourne Sponsored Investigator-Initiated Clinical Trials
Explain how to share trial data with researchers outside of the University of Melbourne.
SOP-15 Document Management and Version Control
To provide the procedure for document management and control, including drafting, issue, filing and revision of clinical trial documents.
SOP-16 Clinical Trial Registration of Investigator-Initiated Trials
Guide researchers on registering clinical trials and keeping registry records updated to meet all requirements.
SOP-17 Copying and Certifying Essential Documents
Explain how to handle and keep official copies of important documents.
SOP-18 Establishing International Clinical Trials
Describe how to establish and oversee international trials following University and regulatory guidelines.
SOP-19 Regulatory Green Light Approval for Clinical Trial Site Activation
Guide on pre-trial checks, approvals and drug release for local and international studies.
SOP-20 Monitoring Visit Activities for Clinical Trials of Investigational Products_
Explain how to monitor clinical trials to meet safety and regulatory standards.
SOP-21 Study Start Up for Clinical Trials
Explains steps for starting University of Melbourne sponsored clinical trials from planning to site activation.
SOP-22 Continuous improvement A Corrective and Preventative Action (CAPA) Plan
How to develop a corrective and preventive action (CAPA) plan.
SOP-23 Obtaining Informed Written Consent from a Medical Treatment Decision Maker
Explains how researchers obtain written consent from a medical treatment decision maker.
SOP-24 Obtaining Informed Verbal Consent from a Medical Treatment Decision Maker
Describes the process for obtaining verbal consent from a medical treatment decision maker.
SOP-25 Obtaining Informed Consent to Continue
Describes how to confirm continued participation after emergency enrolment within a clinical trial.
SOP-26 Opt Out Consent Process
Explains the opt-out consent processes after a medical emergency enrolment as part of a clinical trial.
SOP-28 Audit Preparation and Process
Touches on audit preparation and the process researchers should follow when audited.
TEMPLATE 01 - Green Light Approval Form v1.0
Checklist for the essential documentation required prior to conducting the site initiation meeting.
International Clinical Trials Day Webinar
The Melbourne Centre for Clinical Trials was delighted to host a joint webinar with the Melbourne Academic Centre for Health and the Methods and Implementation Support for Clinical and Health research Hub to celebrate International Clinical Trials Day on the 20th of May 2026. A heartfelt thank you to our wonderful speakers (Mary Stathopoulos, Haustine Patt Panganiban, Renata Phyland and Dr Ana Potemkin) for sharing their expertise and insights.