Melbourne Children’s Trials Centre (MCTC) offers researchers assistance with study start-up, including feasibility assessment, sponsorship approval, ethics submissions, budgeting and contracting.

We can also assist researchers sourcing or connecting with research coordinators/nurses for study conduct, either on a short term or long term contract basis.

MCTC has developed a process of endorsement for Investigator Initiated studies whereby researchers can engage with senior, experienced MCTC researchers and biostatisticians for guidance

and support in developing a research question as well as protocol design and development.

Where researchers require access to inpatient or outpatient clinical space in which to conduct their trial or study, MCTC can assist with evaluating available space for suitability.  Space is limited so it is important to engage with MCTC as early as possible.

For researchers new to industry sponsored or investigator initiated studies, MCTC can provide guidance directly to researchers or link the researcher with other experienced trial investigators.

Depending on the activity and type of study, MCTC may be required to charge for some of the above services. For more information contact MCTC staff on mctc@mcri.edu.au

High quality trials provide the strongest evidence for the choice of treatments in children.

Established processes for trial conduct

MCTC works closely with the Clinical Research Development Office (CRDO) who have implemented numerous initiatives to equip new and current researchers with the resources and tools they require to conduct high quality research.  The following research resources are available.

  • Protocol templates
  • Translation toolkit
  • Study binder toolkit
  • Standard Operating Procedures
  • Forms and templates
  • Links to national research regulations and guidelines

Centralised financial management

MCTC has established defined processes to coordinate clinical trial budgeting and financial management, which offer researchers the ability to accurately budget their clinical trials.  The MCTC Business and Operations Manager will facilitate the conduct of feasibility studies required for commercially sponsored trials, assist with the preparation of study budgets and facilitate the preparation, review and sign off of contracts. MCTC will also facilitate invoicing, payments and budget reporting during the conduct of the study.

MCTC aims to increase efficiency of clinical trials by bringing together existing expertise, and increasing capacity in key areas.

Efficient recruitment from a diverse RCH patient population

Participants in clinical trials are referred from Royal Children’s Hospital clinics, the Emergency Department and the Intensive Care Unit. For recruitment in community trials the campus has strong ties with paediatricians and primary schools.

Streamlined ethics submission and approval processes

High quality ethics submissions ensure timely approval.  Our Ethics Submission Specialist can provide guidance on the preparation of ethics submissions and centralised preparation of ethics documents.

Clinical Trial Management System (CTMS)

MCTC is implementing a Clinical Trial Management System (CTMS) to capture top level information for all clinical trials and research studies conducted on campus.  This centralised trial information will enable the Campus to efficiently report on general trial activities and performance.  The CTMS also provides study specific management modules to enable individual study teams to enhance their study management and tracking.  MCTC is also working closely with the EPIC project team to ensure effective clinical trial visibility in terms of the new hospital Electronic Medical Record (EMR) which will ultimately aid in patient recruitment.

Florence eBinders

Florence eBinders is a new cloud-based filing platform purpose built for clinical trials.  Key features include:

  • Cloud based filing
  • Digital Signatures
  • Redaction Tools
  • Placeholder reporting
  • Role-tailored access
  • Full 21 CFR Part 11 and GDPR compliance

CRDO and CEBU offer clinical research staff training in Good Clinical Practice (GCP) as well as:

Experienced and dedicated research nurses

MCTC has a team of research nurses experienced in all phases of clinical trials, who coordinate study activities from start up to close out.  During the course of a study, research nurses will facilitate study visits, coordinate hospital supporting department set-up and recruit, screen and assist with eligibility determination of study participants.

Ethics submission specialists

Ethics and governance applications form a significant time component of starting up a new research project. The MCTC ethics submission specialists can assist research teams with the completion of full ethics applications to meet RCH HREC expectations and timelines. They have experience in single and multi-centre ethics submissions, as well as investigator initiated projects and pharmaceutical sponsored trials.All of these specialists have built strong working relationships with Supporting Departments across the Campus.

Biostatisticians and data support

The MCTC works closely with the Clinical Epidemiology and Biostatistics Unit (CEBU), the lead partner in an NHMRC Centre of Research Excellence in biostatistics. Members of the biostatistics team have extensive experience in clinical trial design and analysis, and can provide support for trials on campus including development of the research question, protocol development, sample size estimation, data collection and management, statistical analysis and paper writing. By engaging early with the MCTC researchers are able to engage with a statistician, essential for high-quality research.

Business and Operations Manager

Our Business and Operations Manager is responsible for the management, operation and administration of MCTC services. Her role specifically includes financial management and budget negotiations to ensure clinical trials are costed and remitted appropriately, guaranteeing the sustainability of research at the Melbourne Children’s. The Business and Operations Manager is also responsible for facilitate contract review and sign off and conducting feasibility studies.

Drug study area

Located on Level two of the West Building, the drug study area (formerly known as the Australian Paediatric Pharmacology Research Unit, APPRU) is equipped in much the same way as an inpatient hospital ward.  The area meets all regulatory and safety requirements for the conduct of high risk and early phase drug trials.

Administrative offices and support area

Administrative offices on Level four of the South Building accommodate a range of staff required to support MCTC activities.  This area provides the necessary security and confidentiality requirements for the management of clinical trials data entry and documentation.  Meeting, education and training rooms are also available.

Observational research and outpatient clinic area

Outpatient clinic rooms are located on Level 4 of the West Building and offer a mix of interview, video, consult and procedure rooms. The area has a large family friendly waiting area, and is overseen daily by receptionists who can assist with room bookings and managing appointments.

In order to be a leader in clinical trials, MCTC has invested in innovation.

Clinical trials integrated into Australia’s first and most advanced EMR (EPIC)

EPIC, the Royal Children’s Hospital’s Electronic Medical Record (EMR), will use the latest technology to provide a smart record, with inbuilt features that will improve the safety and care of patients. Features include warning of possible medication allergies, upload of patient observations direct from monitors and alerts for patient eligibility for a clinical trial. MCTC is working closely with the EPIC project team on the integration of clinical trials with the system.

Close links with health economists at the University of Melbourne

With clinical trials being increasingly viewed as a natural vehicle for economic analysis, MCTC has developed close links with leading health economists at the University of Melbourne.  Researchers engaging with MCTC can access expert guidance on trial design, to capture relevant and important economic outcome measures in order to determine the impact of therapy on overall resource use.

Investment into innovative trial design and conduct

Differential patient dropout, treatment cross-over and non-adherence occur frequently in clinical trials and can lead to substantial bias in effect estimation. Recent methodological developments provide solutions to these problems but require consideration at both the design and analysis stage of a trial. In collaboration with the Clinical Epidemiology and Biostatistics Unit (CEBU), MCTC has invested in innovation into trial methodology and enforces the application and development of enhanced study designs and inference techniques.

The INPRES Partnership is a collaboration between institutions around the world, leading and undertaking research in the field of perinatology.

The Partnership, founded in 2021 by two world-leading paediatric clinical trials unit: Melbourne Children’s Trial Centre (MCTC) and the University of Oxford’s National Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit, aims to support clinicians and researchers in developing and facilitating clinical trials and observational research projects in the perinatal, neonatal, and paediatric population.

The goal of INPRES is to enable the world’s experts in the perinatal, neonatal, and paediatric clinical research field to work together to improve diagnosis, implement personalised treatment decisions, and develop new treatment strategies that will benefit newborn infants and their families around the world.

The cross-border sharing of expertise, knowledge and leveraging of scientific and clinical strengths between leading perinatal clinician scientists and clinical trial teams, will accelerate and advance the development and execution of collaborative, international, investigator-led research.

Through the Partnership, collaborations are facilitated to promote and foster clinical research, combining research efforts already underway in addition to developing new research proposals. This involves cooperation at multiple levels including the individual project level, as well as partnering to develop the infrastructure required to support programs of research.

All members will work together to lay the groundwork for future networking prospects, with the intent of expanding to include additional perinatal, neonatal, and paediatric research groups globally, in order to further accomplish its mission.

Current Partners

The Murdoch Children’s Research Institute:

Melbourne Children’s Trial Centre (MCTC)

www.mcri.edu.au

 

The University of Oxford:

National Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit

 https://www.npeu.ox.ac.uk/

 

 

Current Research Activities:

 

www.POLARTrial.org.au

 

The Partnership’s flagship project, the POLAR trial, aims to establish how to best, and safely, support the fragile lungs of premature babies at birth.

This trial will compare two commonly used respiratory strategies that both use gentle pressure to open the lungs. The trial will assess whether a brief period of higher oxygen pressure at birth, called PEEP (positive end expiratory pressure), which is adjusted to the oxygen and breathing needs of the baby, helps premature babies immediately after birth, and improves their survival without chronic lung disease, compared with the current typical newborn resuscitation practice of a using a lower, unchanging level of PEEP (commonly referred to as static PEEP).

Through this we hope to give guidance to clinicians that can be easily, rapidly, and cheaply be translated into everyday practice.

 

 

The James Lind Alliance (JLA)
Priority Setting Partnership in the Tiniest Infants

 

 

The James Lind Alliance (JLA) is a non-profit making initiative, established in 2004. It brings patients, carers, and clinicians together in Priority Setting Partnership’s (PSPs). These PSPs identify and prioritise evidence uncertainties, or unanswered questions, that patients, carers, and clinicians agree are the most important.

The aim of this exercise is to help ensure that those who fund health research are aware of what really matters to the people who need to use the research in their everyday lives.

The specific aim of our PSP exercise is to prioritise the most important questions for the most premature of infants born <25 weeks of gestation.

 

Additional research projects are in the early phases of development.

 

Further Information

For further information regarding the INPRES Partnership or requests to join the international partnership, please contact laura.galletta@mcri.edu.au 

For access to templates, toolkits, guidelines and more information regarding trials please visit the Research Launching Pad

Want to know more?

To engage with the MCTC please send an email to mctc@mcri.edu.au

To find the details of a particular staff member, please visit the contact us page