The Palliative Care Clinical Studies Collaborative (PaCCSC) is a research infrastructure that consists of a Coordinating Agency, Flinders University

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2 The Palliative Care Clinical Studies Collaborative (PaCCSC) is a research infrastructure that consists of a Coordinating Agency, Flinders University of South Australia, a committee structure including a Management Advisory Board (MAB), and a number of agencies that will be collaboratively involved in a number of Phase 3 and Phase 4 clinical medication studies.

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4 Phase 3 clinical studies will verify the effectiveness of individual medication in symptom management for palliative care patients, and Phase 4 (or pharmacovigilance studies) 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). The aims of the PaCCSC are to: develop an efficient and effective method of generating research data that will support the listing of palliative care medicines on the ARTG; to build the research capacity of the palliative care sector so that ongoing clinical medication studies can occur; and to build the evidence base to support the ongoing implementation of studies on medicine use and quality practice in palliative care. 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 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. To date, the project outcomes that have been achieved are: The establishment of the supporting committees and standard operating procedures for PaCCSC; Letters of Agreement entered into with six research sites across Australia to agree to become partner organisations with PaCCSC and to contribute to ongoing clinical medication studies in palliative care; The development of methodology and documentation for ethics approval for the initial medication studies.

5 There are currently six phase 3 partner organisations/agencies associated with PaCCSC. This number will increase throughout the life of this Project as will the number of studies conducted by 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. The expected outcomes for this Project are: Six completed Phase 3 clinical medication studies with at least one other Phase 3 study developed to full protocol; Phase 4 data to support the completed phase 3 studies; A pharmacovigiliance study on the prescribing of benzodiazepines in the palliative care population; Drug utilisation research on medicines with dual listing in the Schedule of Pharmaceutical Benefits; Analysed data that will support possible submissions to Therapeutic Drugs Administration (TGA) and PBAC; Evidence to support the clinical usage of medicines in palliative care; PaCCSC Reporting Lines Executive Group Management Advisory Board Data Analysis Subcommittee Increased investigator capacity within the palliative care research community to undertake multi-site clinical medication studies in palliative care; and An increased awareness by the pharmaceutical industry of the needs in the community for palliative care medicines and increased responsiveness. Management Committee Data Safety & Monitoring Committee Scientific Committee Publications & Implementation Subcommittee Phase 4 Committee

6 Enquiries p e maree.tumbas@rgh.sa.gov.au Flinders University receives funding for PaCCSC from the Australian Government Department of Health and Ageing under the National Palliative Care Program.