Clinical Cancer Research Network (CCRN)
About UsThe CCRN office was established in 2007 with the goal of providing support and facilitating communication with cancer clinical trial units across Hunter New England Local Health District (HNE LHD), whom otherwise operated autonomously. To date, the CCRN has promoted integration across 13 diverse clinical trial units, facilitating efficient conduct of cancer clinical trials throughout Hunter New England (public & private settings).
The CCRN office have developed a Site Information Booklet / Schedule of Fees
- Information resource to assist sponsors with determining the feasibility of conducting cancer clinical trials In the Hunter New England region.
- Tool to assist sponsors and clinical trial units with estimating costs associated with conducting cancer clinical trials In the Hunter New England region.
Conducting Cancer Clinical Trials in the HNE RegionThe CCRN is well established, with positive relationships existing between all 13 CTUs. The impact of establishing the CCRN office can be seen in the following three main, interrelated areas.
Figure 1. CCRN key activities and outputs
a. Quality Assurance (Quality Research Management Practices)All clinical trial units under the HNE CCRN umbrella operate with the highest quality of research management practices.
Each trial unit complies with the following National guiding principles;
The National Health and Medical Research Council’s (NHMRC):
The Therapeutic Goods Administration’s (TGA):
Standard Operating Procedures
All CCRN trial units follow a set of nine (9) Standard Operating Procedures (SOPs). These SOPs were specifically developed by the CCRN office, in consultation with all trial units, as a quality management system. The SOPs are based on guidance principles outlined in the TGA’s annotated version of ICH GCP E6 (1996), the NHMRC’s National Statement on Ethical Conduct in Human Research (2007), NSW Health’s National Ethics Application policy (2007) as well as local regulatory and governance requirements.
N.B The SOPs were developed to meet all regulatory requirements. Each SOP was independently reviewed by an external QA consultant prior to being implemented and adopted by the individual clinical trial units in 2010.
Internal Audit Program
All CCRN trial units have been involved in an internal audit program (peer – peer review). This program, operating since 2009, was developed as a quality assurance tool with the goal of ensuring trial units maintain the highest of standards through adherence to ethical and regulatory standards. A total of 27 internal audits have been conducted.
Through peer review, transparency was encouraged & trial units exchanged useful techniques/processes that increased the efficiency of their own unit. The internal audit program promoted CTUs to achieve regulatory compliance by performing a systematic evaluation of the following areas:
- Adherence to trial unit SOPs
- Risk Management: participant safety
- Data integrity / validity (critical data points)
- Protocol Compliance
For further information or to obtain a copy of the CCRN SOPs or Internal Audit Program please contact the CCRN office on email@example.com.
b. CommunicationPatient Management
All patients recruited onto a clinical trial across the CCRN receive specialised treatment by a dedicated team of investigators and trial coordinators. Trial visits are arranged and coordinated in advance as to protocol requirements, and consistent, friendly patient follow up strategies ensure patients maintain satisfaction in participating in the clinical trials, leading ultimately to effective patient retention.
Clinical Cancer Research in the Hunter New England region prides itself on its well-coordinated patient services. With the belief that communication is the key, multiple strategies are used to inform everyone involved in patient care, from support services to cancer care coordinators, are up to date with current and upcoming clinical trials.
c. Training and Education Experienced Research Staff
Ongoing training and professional development is highly regarded for all members of the CCRN.
- Clinical trial orientation is provided by the CCRN office for all new trial coordinators
- All CCRN trial coordinators and Investigators complete Good Clinical Practice training conducted by a leading external QA consultancy firm, Caledonian Clinical Training. Refresher GCP courses are held bi-annually.
- Webinars and face to face education/information sessions, coordinated by the CCRN office, are held on a regular basis with invitations to all CCRN members. Sessions include;
- Pathology and treatments of disease states such as ovarian cancer, prostate cancer, colon cancer, lung cancer, rectal cancer
- Data management, including investigator site files, delegation logs
- Safety Reporting: SAE/AEs, SUSARs
- Ethics and research Governance: responsibilities of lead sites
- Radiation safety requirements
- Other areas of training and development regularly coordinated by the CCRN and attended by most members of the CCRN include;
- Ethics & regulatory training
- Communication skills