Industry and sponsors
The Melbourne Children’s Trials Centre (MCTC) supports the Melbourne Children’s Campus by overseeing more than 70 active clinical trials in all phases of drug development, and in a wide range of indications, including cancer. With access to dedicated staff, skills, and space as required, MCTC can enable investigators to conduct each trial efficiently and to high quality standards.
Please click here to download a booklet detailing key MCTC capabilities.
Trials are essential to the Melbourne Children’s because they:
- Increase the knowledge base to improve healthcare for children
- Provide children access to new and novel therapies
- Deliver on core hospital KPIs
MCTC understands there are key drivers for industry and other sponsors in their selection of sites for the conduct of clinical trials. To this end, MCTC aims to deliver:
|Time||Short time frames to ethics approvals and study start up|
|Recruitment||Reliable and innovative recruitment strategies to achieve study targets|
|Quality||Experienced and trained staff to conduct studies to the highest quality standards|
The top 6 areas of research at the Melbourne Children’s are:
|Cancer||Psycho-social||Vaccines and infectious diseases||Respiratory||Blood disorders||Metabolism|
Dedicated study coordinators and research nurses
A team of experienced coordinator and nursing staff ensure clinical trials are conducted according to the protocol, Good Clinical Practice (GCP) and agreed timelines.
- Coordinate and facilitate study visits
- Coordinate hospital supporting department set-up
- Recruit, screen and assist with eligibility determination
- Complete data entry according to agreed study timelines
Ethics submission specialist
High quality ethics submissions ensures timely approval. In providing the services of an Ethics Submission Specialist, MCTC offers centralised, consistent preparation of ethics documents. Close liaison with the sponsor and HREC by the Ethics Submission Specialist ensures a smooth process of review and approval.
- Complete full ethics applications to meet RCH ethics committee expectations and timelines
- Experience in managing multi-centre ethics submissions
Business and Operations Manager
The MCTC Business and Operations Manager offers a single point of contact for sponsor companies looking to engage with the campus for new clinical trials.
- Supervise and co-ordinate feasibility studies for proposed clinical trials
- Review and negotiation of budgets in conjunction with investigators
- Finalise Clinical Trial Research Agreements and Indemnities and arrange for institutional sign off
- Ensure appropriate allocation of space and staff for the conduct of the study
- Facilitate sponsor invoicing through centralised financial management system
Recruitment to clinical trials involves participants being referred from Royal Children’s Hospital clinics, Emergency Department and Intensive Care Unit. For community trials the campus has strong ties with paediatricians and primary schools for access to participants. In terms of recruitment MCTC benefits from a diverse RCH patient population.
Melbourne Children’s is also integrating clinical trials into Australia’s first and most advanced Electronic Medical Record (EPIC) due to be launched in 2016.
Paediatric Trials Network Australia (PTNA)
Melbourne Children’s is a founding member of Paediatric Trials Network Australia (PTNA). PTNA draws together paediatric researchers from around the country dedicated to improving child health through the facilitation of paediatric clinical trials. The network provides industry and other sponsors with access to a critical mass of researchers and research participants across Australia so clinical trials, in particular in rare diseases, can be successfully completed.
Velo e-Research is a Clinical Trial Management System (CTMS) software used in all Victorian Comprehensive Cancer Centre (VCCC) partners and is a vital part of increasing our capacity in oncology trials. The system is also able to be used for non-oncology trials for tracking study progress, patient recruitment, patient visits, budget management and invoicing. Velos e-Research will be integrated with the new electronic medical record EPIC to more efficiently conduct research across Melbourne Children’s.
Centralised financial management of clinical trials through MCTC offers investigators the ability to more accurately and consistently budget their clinical trials and offers sponsors a single point of contact for the preparation of budgets and clinical trial research agreements. Investigators are therefore able to keep track of invoicing and study payments in a timely manner.
Melbourne Children’s Trials Centre (MCTC) brings together expertise both geographically and functionally in the design and conduct of clinical trials. We also provide campus researchers with support for all types of clinical research ranging from trials of novel therapeutic agents to large public health prevention trials. We aim for excellence and leadership in paediatric health research bringing new therapies to children and generating knowledge to better the health of all children.
Clinical Research Development Office (CRDO)
The Clinical Research Development Office (CRDO) offers clinical research staff training in Good Clinical Practice (GCP) as well as:
- Workshops on managing a research project
- Start up education sessions for new clinical research groups
- Links with national and international research groups
Drug study area
Located on Level 2 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 4 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 ensuring researchers are contacted when patients arrive for appointments.
Now Gene Therapy Ready!
The MCTC has the capability to deliver in vivo viral vector gene therapies.
The Gene Therapy Trials Readiness Coordinator has expertise in the regulations around gene therapy trials and can provide advice or assist in the set up for trials.
Site gene therapy capabilities include:
- Clinical trials pharmacy with staff trained in the preparation of GMO products
- Suitable facilities for pharmacy preparation of GMO products
- SOPs for GMO handling
- GMO waste disposal
- Institutional Biosafety Committee
- Local review of studies with OGTR licenses
- Submission of protocols to the OGTR to obtain license
- Training for clinical staff in handling of GMOs
- Assistance with the submission gene therapy trials to the RCH HREC and RGO
To enquire about including RCH as a site in a gene therapy trial, please reach out to MCTC by emailing firstname.lastname@example.org, or contact the Gene Therapy Trials Readiness Coordinator directly at email@example.com
MCTC is in the process of implementing Florence eBinders, a cloud based filing platform purpose built for clinical trials. With a click of a button, Research Coordinators can provide Monitors remote viewing access to the eISF, and can generate reports on document workflows and timelines.
Florence ensures 21 CFR Part 11 and GDPR compliance, maintaining meta data, audit trails, and version history of all files.
To engage with the MCTC please send an email to firstname.lastname@example.org
To find the details of a particular staff member, please visit the contact us page.