Cancer Australia Supporting cancer clinical trials in Australia Evaluation framework and performance criteria

Transcription

1 Cancer Australia Supporting cancer clinical trials in Australia Evaluation framework and performance criteria Background Through the Support for Cancer Clinical Trials program the Australian Government provides $5 million per annum to build Australia s capacity to conduct cancer clinical trials. This program is administered through Cancer Australia and currently there are 12 Multi-site, Collaborative National Cancer Clinical Trials Groups supported under this program. They are: Australasian Gastro-Intestinal Trials Group; Australasian Leukaemia and Lymphoma Group; Australasian Lung Cancer Trials Group; Australia and New Zealand Melanoma Trials Group; Australia New Zealand Gynaecological Oncology Group; Australian and New Zealand Children s Haematology and Oncology Group; Australian and New Zealand Urogenital and Prostate Cancer Trials Group; Australian New Zealand Breast Cancer Trials Group; Australian Sarcoma Study Group; Cooperative Trials Group for Neuro-oncology; Psycho-Oncology Co-operative Research Group; and Trans-Tasman Radiation Oncology Group. Under the Boost Cancer Research program, the Australian Government has committed an additional $5 million per annum through until for independent clinical trials of drugs and research into cancer treatment. This measure includes options to support the establishment of new Multi-site Collaborative National Cancer Clinical Trials Groups and to provide research grant funding for industry-independent cancer clinical trials*. Under this program, the Australian Government established the Primary Care Collaborative Cancer Clinical Trials Group. Cancer Australia Evaluation Framework and Performance Criteria *Industry-independent clinical trials are defined as investigator-initiated clinical trials where collection, analysis and ownership of data together with dissemination of findings lies within the control of the research collaborative.

2 Program objective The objective of this program is to build Australia s capacity to conduct cancer clinical trials by supporting and increasing the number of cancer clinical trials conducted in Australia and increasing participation in clinical trials by cancer patients and clinical professionals. It is a formal requirement that Cancer Australia evaluates and reports on the Boost Cancer Research and Support for Cancer Clinical Trials programs. The evaluation framework and performance criteria provides a reporting structure for the Multi-site Collaborative National Cancer Clinical Trials Groups assisting them to measure and benchmark their performance across a range of indicators over time, and will offer a means for Cancer Australia to assess the outcomes and impact of these programs. Evaluation should be continuous and should address both process and outcomes. The evaluation framework, performance measures, and reporting structure must be designed, implemented and reviewed in this context. Goal To implement an evaluation framework, and define performance criteria by which to measure program outcomes, and evaluate and report processes and activities funded by the Boost Cancer Research and Support for Cancer Clinical Trials programs. Performance criteria The performance criteria listed below (Attachment 1) include a combination of performance and process measures. Performance criteria outlined in Cooperative Clinical Trials in Cancer the need for increased capacity (The Wall Report; Oceania Health Consulting, 2002) has been incorporated into these criteria. Measures are grouped by those collected every six months, annually and longer term outcome measures which will be reported at the end of the funding period. Each performance measure is linked back to a in the Cancer Australia Principles Document. The s outlined in this document form a guiding framework for the Multi-site Collaborative National Cancer Clinical Trials Groups as they apply for funding from the Boost Cancer Research and Support for Cancer Clinical Trials programs. The s are listed in the Cancer Australia Principles Document. Initial data collection forms a baseline for comparison in future developments of the programs. Evaluation framework To document the progress and impact of the Boost Cancer Research and Support for Cancer Clinical Trials programs, the performance criteria should be assessed at regular intervals. The evaluation framework will provide a structure by which the performance criteria relating to outcome and impact measures will be measured and evaluated in a timely and meaningful way. The evaluation framework will comprise of baseline data reporting and ongoing data collection and reporting (see Figure 1). The evaluation framework should be viewed as a cyclic process which incorporates ongoing measurement and evaluation of performance, process and impacts. When they are first established and in the short term, new Multi-site Collaborative National Cancer Clinical Trials Groups may not be able to report against all measures outlined in the evaluation framework, however, it is anticipated that over time these new groups will be able to report against most measures listed. Cancer Australia Evaluation Framework and Performance Criteria

3 Figure 1: Evaluation framework Baseline Data Performance measures Process measures Impact measures Reporting Baseline data and reporting In order for the Multi-site Collaborative National Cancer Clinical Trials Groups to measure their performance over time and for Cancer Australia to assess the impact of the Boost Cancer Research and Support for Cancer Clinical Trials programs, it will be necessary to collect base line data relating to the selected performance criteria. The baseline data will collect and review the governance, processes and clinical trials activities related to the performance criteria for the Multi-site Collaborative National Cancer Clinical Trials Groups. Implementation and timelines The evaluation framework and acceptance and adherence to reporting requirements will be a specified deliverable in the Boost Cancer Research and Support for Clinical Trials program grants. Reports will be required on a six monthly and annual basis. A final report will be required at the end of the funding period. The reports will be reviewed by the National Manager of Research and staff within the Research and Clinical Trials section of Cancer Australia. Reports will be kept confidential and the reports will not be distributed without the permission of the Chair of the relevant Multi-site Collaborative National Cancer Clinical Trials Group. The submission of reports will be linked to payments under the Cancer Australia funding agreement. The data provided in the reports will be used by Cancer Australia to assist measure the impact of the Boost Cancer Research and Support for Cancer Clinical Trials programs. In particular, aggregated data from reports will be used to demonstrate changes in different measures such as capacity, membership, trial activity, consumer involvement and collaboration. The evaluation of the program may be submitted to the Australian Government and the Minister for Health and Ageing. Summary de-identified data may also be published in Cancer Australia s Annual Report. Multi-site Collaborative National Cancer Clinical Trials Cancer Australia Evaluation Framework and Performance Criteria

4 Groups will have access to the summary data. It is acknowledged that different groups are at different stages of development and data will not be used to compare activities with other Multi-site Collaborative National Cancer Clinical Trials Groups. Cancer Australia Evaluation Framework and Performance Criteria

5 Attachment 1: Performance Criteria 6 month Measure Measure Related Necessary 1 11 Financial accountability Measure: Financial statement/ audited financial statement (annual) and evaluation of spending in line with approved budget provided by Cancer Australia 2 11 Adherence to plans Measure: Progress, challenges/ difficulties, changes to key outcomes/ activities 3 2, 3 & 4 Staffing Measure: details of the total number and FTE of staff that have been employed to the Groups Annual * Measure Measure Related Necessary 4 2, 3 & 4 Defined governance structure and succession planning and central plans Measure: details on changes/ implementation/ operational aspects of the Group s governance structure, succession planning; development/ implementation of strategic/ business/ disaster recovery plan 5 1 & 6 Membership of Multi-site Collaborative National Cancer Clinical Trials Group Measure 5.1: Number of group members. Measure 5.2: Number and percentage of members from states and territories. Measure 5.3: Activities undertaken to increase membership. Measure 5.4: Number and percentage of members from rural and regional Australia. Measure 5.5: Activities undertaken to engage members in rural and regional areas. Measure 5.6: Number and percentage of members across different disciplines. Measure 5.7: Activities undertaken to mentor/ build experience/ capacity in your Group 6 14 & 15 Pilot Study or Clinical Trial Protocols Developed Measure: Number, type, and description of protocols developed 7 6, 7, 13, 14 & 15 Trial Recruitment Measure: Number of trials open for recruitment, sites recruiting, number of patients recruited 8 7 Trials registered on Australian Clinical Trials Registry (ACTR) and accessible through Australian Cancer Trials Measure: Trials listed on the Australian Cancer Trials Registry and accessible through Australian Cancer Trials consumer portal. 9 7 Profile of patient recruitment Measure: Number of patients recruited to trials by state 10 2 & 7 Consumer involvement Measure: Involvement of Consumers in the Governance Structure, Conception/ Design and Conduct of Clinical Trials or Other Studies 11 8 Capacity building and engagement of other Multi-site Collaborative National Cancer Clinical Trials Groups Measure: Number and type of joint activities undertaken 12 6 Number of competitive grants awarded to trials developed by the Multi-site Collaborative National Cancer Clinical Trials Groups Measure: Number of competitive grants awarded in this reporting period with total amounts Cancer Australia Evaluation Framework and Performance Criteria

6 13 5 QA activities including audit activities for trials undertaken Measure: Number and type of QA activities undertaken. development/ implementation/ review of agreed minimum audit and quality standards 14 9 Facilitating translation of results into policy and practice Measure 14.1: Peer & non-peer reviewed publications produced as an outcome of clinical trials or studies: peer reviewed/non-peer reviewed journal articles book chapters conference presentations abstracts clinical guidelines systematic reviews Measure 14.2: Details of other activities undertaken by the Group to translate the outcome of your trials into further research, practice or policy Use of national support services Measure: evaluation of use and quality of national support services Measure Related Process mapping for all new trials 16 6 & 7 Participation of patients from non-metropolitan locations, Aboriginal, Torres Straight Islander and Culturally and Linguistically Diverse backgrounds Measure 16.1: Postcode of patients (application of ARIA (Accessibility/Remoteness Index of Australia) classification will identify participation of patients from non metropolitan locations) Measure 16.2: Number of patients from Aboriginal, Torres Straight Islander and Culturally and Linguistically Diverse backgrounds Please note that this process mapping will only commence when data elements to be collected have been finalized. Long Measure term outcomes Measure Related Necessary 17 9 Changes in treatment/ care/ health outcomes Measure: measurable in 5-10 years 18 9 Translation of results into routine clinical practice or policy Measure: Uptake of trial results into routine practice/ guidelines * Annual reporting = six month measures plus annual measures Cancer Australia Evaluation Framework and Performance Criteria

7 Guiding s The following set of s will form a guiding framework for the Multi-site Collaborative National Cancer Clinical Trials Groups as they apply for funding from the Boost Cancer Research and Support for Cancer Clinical Trials programs. It will be a condition of funding that the Multi-site Collaborative National Cancer Clinical Trials Groups demonstrate compliance with these guiding s. Principle 1 National, multi-disciplinary membership Principle 2 Governance structure Principle 3 Succession planning Principle 4 Strategic and business planning Principle 5 Data and quality Principle 6 Capacity building Principle 7 Consumer involvement in clinical trials Principle 8 Collaboration and mentoring Principle 9 Translation into policy and practice Principle 10 Support services Principle 11 Evaluation framework Principle 12 National and international policies and guidelines Principle 13 Data ownership Principle 14 - Investigator initiated trials Principle 15 Improvements in health outcomes More details regarding these guiding s can be found in the Cancer Australia Principles document. Cancer Australia Evaluation Framework and Performance Criteria