Researchers

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:

• Short courses in methods of quantitative research, including Getting started in clinical research, Data management and Introduction to Biostatistics
• Workshops on managing a research project, including Guidelines and Legislation, Ethical requirements and Information Consent Essentials
• Start up education sessions for new clinical research groups

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.