In 2005, COSA & the Cancer Cooperative Trials Groups (CTGs) 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 3 areas:
- Protocol development from concept outline to externally approved protocols
- Web-based randomisation and data collection
- Independent, comprehensive quality assurance program
Summary of Achievements
Over the last four years, substantial progress has been made in each of these areas. The achievements of this Enabling Grant include but are not limited to the following:
- The development of a comprehensive governance structure (pdf, 22kb) to manage the Enabling Project. This structure includes the collaborative input of all member CCTGs and other key stakeholders involved in clinical trials.
- In partnership with COSA, worked to develop and provide ongoing support to the Executive Officers Network. Membership consists of the senior operations staff of COSA and all he Cancer Cooperative Trial Groups and facilitates open discussion, information sharing and stronger links between the groups generating a range of efficiencies in the management of clinical trials.
- 39 concepts and protocols developed by mid 2008 with 11 activated and 5 recruiting (pdf,77kb);
- By the end of 2009, it is anticipated that at least 40 protocols will be developed and 20 activated with greater than 500 patients recruited;
- On-line randomisation and data management system available and in use with 5 trials;
- QA workshop defined terms and prioritised strategies;
- Development of a Table of Contents of Standard Operating Procedures (SOPs) for Group Governance, Trial Coordinating Centres and Participating Sites;
- 3 Workshops on clinical trials education and training have been conducted;
- Report (pdf, 636kb) on the availability of clinical trials education detailing available education programs for clinical research staff completed;
- Presentation and evaluation of eight modules of clinical trials education presented in face-to face format;
- Completion of a Clinical Trials Research Agreement (CTRA) template for Cooperative Trial Groups and participating sites. Adaptation of this CTRA for use in other environments (New Zealand, private hospitals) is underway;
- Comprehensive report on insurance and indemnity for clinical trials in Australia;
- Establishment of an Umbrella clinical trials insurance policy for 9 CTGs at a substantially reduced overall cost of the premium.
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
Margie Campbell
Program Coordinator
Phone: +61 2 8063 4163
Email: margie.campbell@cancer.org.au