In 2005, COSA & the Cancer Cooperative Trials Groups successfully applied for an NHMRC Enabling Grant. We were awarded $1.84 million over 5 years.
Aim
To enhance the capacity of all member Cancer Cooperative Trials Groups of COSA to conduct high quality clinical research by developing and providing fundamental resources in 4 areas:
- Protocol development from concept outline to externally approved protocol
- Web-based randomisation and data collection
- Independent, comprehensive quality assurance program
- Standardised operating procedures
Achievements
The Enabling Project has achieved several important outcomes in the key areas of the project. These include but are not limited to the following:
- The development of a comprehensive governance structure (pdf, 44kb) to manage the Enabling Project. This structure includes the collaborative input of all member CCTGs and other key stakeholders working in the clinical trials field.
- In partnership with COSA, worked to develop and provide ongoing support to the Executive Officers Network. This group is a collaborative network of Executive Officers (or equivalent positions) of the COSA and ANZ Cancer Cooperative Trials Groups (CCTG). The aim of the Network is to:
- Increase the efficiency of cancer cooperative research through sharing of information
- Provide a forum for discussion and exchange of experiences and information
- Identify and address the needs of Executive Officers through mentoring and identification of relevant education and training opportunities
- Strengthen relationships between the CCTGs
- Commissioned a report by Healthcare Risk Resources International to review the indemnity requirements for clinical trials at all levels and in all states across Australia and New Zealand
- The report was presented at the COSA ASM in November 2007.
Protocol development
Specific aims
- To develop a set of generic tools and templates for cancer clinical trial protocol development
- Review of generic protocol tools by Steering Committee
- Facilitate a series of new protocols developed utilising generic tools
- Piloting of generic protocol tools at 2006 ACORD Workshop
- Training sessions on efficient use of protocol tools offered to all members
Achievements
- The Enabling Project has supported the development of 23 concepts and protocols. View a breakdown of concepts and protocols (pdf, 25kb).
- In addition the Enabling Project has supported the following:
- Ethics submissions
- Study preparation
- Feasibility assessment
- Statistical modeling
- Investigator meetings
- Minutes and meetings
- Trial centre data management
- Representation at meetings
- 0.166 FTE Statistician
- 1.25 FTE Trial Coordinator
- 0.012 FTE Executive Officer
- 0.1 FTE Data manager
Information systems
Specific aims
- Evaluate current systems and processes within CCTGs and IT collaborators
- Steering Committee agreement on priorities for software development
- IT collaborators to develop agreed modules of applications towards web-based functionality
- IT collaborators to provide access to clinical trials website for each CCTG
Achievements
- The Information systems subcommittee of the Enabling project conducted a needs assessment for all CCTGs in Feb 2006
- A comprehensive review of existing clinical trials web-based management systems including e-CRF, randomisation and drug management modules was the undertaken by the project
- Most recently, funds have been provided to support the ongoing development of: the NHMRC Clinical Trials Centre Flexetrial system registration/randomisation and e-CRF systems at the Peter MacCallum Cancer Centre. This investment will help to ensure that Australian CCTG are operating to the latest world standard.
Quality assurance
Specific aims
- Review existing QA programs and resources
- Identify QA needs of CCTGs in relation to GCP and training in GCP
- Completion of two training courses; review pilot data by QA committee
- Roll out training courses for online learning of CCTG staff and members from COSA website
Achievements
- The CCTG undertook a needs assessment to address requirements in this area in June 2006
- A Quality Assurance Workshop (pdf, 81kb) which had broad consumer representation was held on the 25 August 2006. The purpose of this workshop was to agree on definitions in QA terminology and identify a collaborative way to address the specific aims. The workshop identified the need for the development of a standardised education program and the development of basic QA standards, specifically SOPs.
- A training course in Clinical Trials Operational Procedures has been developed by an Education and Training Working Party and the Quality Assurance Subcommittee. This training program has been piloted at the ANZBCTG meeting in July 2007 and at the COSA ASM in Nov 2007 and at the Australian Health & Research Data Managers Association (AHRDMA) meeting in March 2008. A report on the pilot ICH GCP Workshop is available for viewing.
- A review of national and interantional clinical trials education programs is in the midst of being completed.
Standard Operating Procedures (SOP)
Specific aims
- Obtain and review standard operating procedures & available resources of all coordinating centres
- Where appropriate, acquire SOPs and make available for all CCTGs
- Undertake a SOP pilot project, refine it and provide training for CTG staff
- Complete an annual review of SOPs and circulation of revisions
Achievements
- A SOP Working Party has been formed
- Currently the Enabling Project is working to collect and seek agreement on an SOP index for coordinating centres
- In addition, work has commenced to review SOPs for investigational sites and with Cancer Institute NSW recommend minimum standard
For further information about the Enabling Project please contact:
Prof Steve Ackland
Chief Investigator
Phone +61 2 49 211155
Email: stephen.ackland@newcastle.edu.au
Laura Jakob
Program Coordinator
Phone: +61 2 8063 4163
Email: laura.jakob@cancer.org.au