Clinical Trials Jurisdictional Working Group: Update

Transcription

1 ACTA International Clinical Trials Symposium Clinical Trials Jurisdictional Working Group: Update James Cokayne Principal Policy Officer, Research Ethics and Governance Unit NSW Office for Health and Medical Research 10 October

2 CT-JWG Vision Australia viewed as a single clinical trial destination: Federal system fosters variability among States Barrier for international investment in clinical trials Increased consistency needed in study start up Challenge: ensure the national and jurisdictional reform programmes complement each other Important to recognise each of our roles and strengths 1

3 Health Ministers (COAG HC) Minister for Health Minister for Industry and Science Australian Health Ministers Advisory Council (AHMAC) Hospitals Principal Committee (HPC) Member of Reports to Works with National Mutual Acceptance Working Group Clinical Trials Jurisdictional Working Group Clinical Trials Advisory Committee State and Territory Health Commonwealth Health Portfolio Commonwealth Industry and Science Portfolio NHMRC Clinical Trialist, Clinicians and Hospitals Pharmaceutical and Biotech Industry Consumer Groups

4 CT-JWG Purpose To identify and implement actions to enable consistent national approach to multijurisdictional clinical trials within Australia enhance Australia s ability to attract national and international clinical trials. Identify barriers and enablers to a consistent national approach; and identify specific and achievable actions to support the undertaking of clinical trials.

5 Key priority areas (projects) Establish a metrics system and promote ICT interoperability Enhance national consistency for ethics and governance Improve efficiency of recruitment and accruals Strategy for positioning Australia as a preferred location for performing clinical trials Lead¹ VIC Professor Brook NSW Dr Penna (interim) VIC Professor Brook NSW Dr Penna Objectives - Develop and implement a national monitoring system to assess the timeliness and efficiency of clinical trials. - Promote ICT interoperability and consistent regulations, to support nationally compatible systems for clinical trials. - Working with NHMRC, streamline and standardise clinical trial startup processes to maximise efficiency and predictability. - Agree, develop and implement methods to improve recruitment to clinical trials. - Agree where Australia s competitive advantage lies and implement strategies for promoting and positioning Australia as a preferred location for performing clinical trials. Key Activities & Timeframe 1. Agree and seek approval from HPC and AHMAC on a set of reportable metrics to facilitate national reporting, including objectives and data definitions 2. Implement and source the agreed set of metrics and KPIs for commercial trials (Stage 1), then deliver the first national report to HPC and AHMAC 3. Implement a wider set of reportable metrics for both commercial and investigator led trials to include quality and compliance metrics (Stage 2) 4. Develop an ongoing strategy to promote continuous improvement JAN to MAR onwards 1. Participate in NHMRC pilot site project to test proposed governance models. Phased approach across major sites 2. Identify core elements critical to efficiency and predictability, and agree key principles 3. Jurisdictions to implement agreed principles 4. Promote uptake of, and jurisdictional participation in, the National Mutual Acceptance (NMA) Scheme onwards Ongoing 1. Enhance the understanding of barriers and enablers to consumer participation in clinical trials 2. Explore opportunities to support clinicians in the recruitment of patients to clinical trials 3. Explore opportunities to encourage patients to engage in trial seeking behaviour onwards 1. Convene Round Table with key experts in the clinical trials field to identify potential niche areas and how best to position Australia to compete internationally 2. Develop an overarching framework for clinical trial reform 3. Undertake public relation activities to promote awareness of clinical trial reforms 4. Develop a comprehensive communication strategy to position Australia globally as a preferred location for clinical trials Complete JUN JUL onwards onwards 5. Jurisdictions to achieve interoperability as system ICT changes are required Ongoing 5. Expand NMA beyond jurisdictions by encouraging universities and private hospitals to join the scheme Ongoing 4. Explore mechanisms for actively managing slow recruiting trials onwards CTJWG will collaborate with, and contribute to the work of, the Clinical Trials Advisory Committee (CTAC), the National Mutual Acceptance Working Group and key stakeholders as required ¹ Each Jurisdictional Lead will be supported throughout by the Commonwealth Department of Health and, where required, by external Consultants and SMEs February

6 CTJWG Key Priority Areas 1. Establish a nationally-agreed metrics system and promote ICT interoperability To assess timeliness and efficiency of clinical trials Strategic and operational objectives 2. Enhance national consistency for ethics and governance Standardise clinical trial start up processes Result: Efficiency and predictability 3. Improve efficiency of recruitment and accruals 4. Strategy for positioning Australia as a preferred location for clinical trials 5

7 Priorities and consultation Tested with a Roundtable workshop State and Federal Government with Industry and noncommercial sector leaders (Melbourne, Feb ) Industry Liaison Workshops Big, small Pharma and CROs, University & CRG representatives (Melbourne and Sydney, June )

8 National Aggregated Statistics for CT Performance All jurisdictions agree to the same dataset and data dictionary Strategic and organisational level metrics will: Increase transparency Reduce variation Enable governments, organisations and stakeholders to evaluate reform success. McKeon Report: Evaluating and tracking research outcomes will assist in driving the required cultural change towards an impactoriented mind-set, while also increasing the accountability of health professional researchers. 7

9 Enhance National Consistency for E&G Need to maximise efficiency and predictability NHMRC Pilot project testing a proposed governance model Identification of core elements critical to ethics and governance efficiency and predictability. Priority items include: Define/clarify roles and responsibilities (to reduce duplication of activity) Standardise definitions and operational requirements (e.g. the handling and categorisation of amendments to HREC/governance office)

10 Recruitment and Accrual Improve patient recruitment supporting clinicians Expand participation in clinical trials encouraging patients Actively managing slow recruiting trials Perhaps Review current approaches to informed consent Use of GPs / GP Networks / Role of Primary Care Services Look to overseas campaigns

11 Positioning Australia Noting / building on the work of Dept of Industry & Austrade Clinical Trials Capability Report Develop & Implement: Comprehensive communications strategy (Q4 Q2 2016) Selling the positive story / Communicating the reforms Agreeing where Australia s competitive advantage lies

12 Overall Strategy Building on what has already been done Identify and progress the mission critical issues Ensure jurisdictions continue to implement their current strategies fixing up our own backyards is essential Build on this with the interjurisdictional issues Focus on the national agenda and connectivity among States / Territories