The Palliative Care Clinical Studies Collaborative (PaCCSC) was officially launched at the Melbourne Exhibition Centre on Wednesday the 29th of August 2007 by Senator Brett Mason. 

This Project forms part of the Australian Government’s commitment to improve access to and quality use of palliative care medicines in the community and is a key initiative of the National Palliative Care Program. The Department is supported in this work by the Palliative Care Medicines Working Group (PCMWG) which is the Department’s advisory committee on palliative care medicines.

Phase 3 clinical studies will verify the effectiveness of individual medications in symptom management for palliative care patients. Phase 4 current practice and effectiveness will provide additional data on the benefit to risk balance for individual medication including the use of medication in a normal clinical setting and in comparison with current practice.

These studies may support the registration of a number of medicines used in palliative care on the Australian Register of Therapeutic Goods (ARTG) and subsequently support the possible listing of these medicines on the Pharmaceutical Benefits Scheme (PBS).

For the first round of studies,  priority medications have been chosen. These medications have been determined through projects which specifically addressed medications used in palliative care, but were not available on the Pharmaceutical Benefits Schedule for prescribing in palliative care patients managed in the community. The medications to be studied are:

To date, the project outcomes that have been achieved are:

There are currently 8 phase 3 partner organisations/agencies associated with PaCCSC. This number will increase throughout the life of PaCCSC. Conducting a number of parallel studies across a number of organisations/agencies through PaCCSC will ensure effective and efficient recruitment of patients and will build research capacity within the palliative care sector.

Standard Operating Procedures

PaCCSC have developed a number of Standard Operating Procedures (SOPs) to ensure uniformity across activities. These SOPs have been reviewed and endorsed by a series of committees within PaCCSC. While they are specific to PaCCSC,  they may be used by other researchers. Individuals wishing to use the SOPs are asked to email PaCCSC (tania.shelby-james@flinders.com.au) to obtain electronic copies of the official SOPs.

To view the samples of the current SOPs please select from the list below and a PDF will be displayed.

• 4.0 Investigator Roles
• 4.7.1 Randomisation
• 4.7.2 Unblinding
• 5.5.1 Electronic Data Handling
• 5.5.2 Electronic Data Transfer
• 5.5.5 Allocation of ID
• 5.14.1 Investigational Product Handling
• 5.17 Adverse Events
• 5.18 Monitoring
• 5.23.1 KPI Compliance
• 5.23.2 CRF Completion
• 6.0 Protocol Development
• 6.5.1 Study Recruitment
• 6.5.2 Re-screening
• 6.10 Version Tracking
• 6.12 Ethical Approval
• 8.0 Essential Documents
• 8.4.1 Archiving
• 8.4.2 Record Destruction