Clinical Trials and related Initiatives Gordon McGurk Research Policy Taskforce
Overview – NHMRC’s research guidelines (and review) – NHMRC’s Funding for clinical trials – The National Approach (HoMER) and CTAG – NHMRC’s role in the Expediting Clinical Trials Initiative
NHMRC’s Research Guidelines- Development and Review
Australian national standards Endorsed by: � National Health and Medical Research Council � Australian Research Council � Universities Australia
Review of the Australian Code for the Responsible Conduct of Research (2007) • Last reviewed in 2007 • Will be issuing supplementary advice to the Code around: – Implications of the Defence Trade Control Bill ie. Dual Use research – Managing Conflicts of Interest – Open Access Policy (Dissemination of Research Findings) • Will consider other issues for future review
Review of the National Statement on Ethical Conduct in Human Research 2007
From our website • AHEC is undertakes a rolling review of the National Statement on Ethical Conduct in Human Research . • Revisions to the National Statement: – Preparations for public consultation on the inclusion of guidelines on opt-out consent into Chapter 2.3, – Finalisation of Chapter 3.4: Human Biospecimens in Laboratory Based Research , – Appraisal of the National Statement to determine whether it continues to meet the needs of users and to determine priority areas for future review.
NHMRC Funding for Clinical Trials
Clinical Trials funding through Project Grants ($m) $120,000,000 $100,000,000 $80,000,000 Over the last 5 years, the average clinical trials project grant budget was $815,000. $60,000,000 $40,000,000 $20,000,000 $0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
NHMRC Funding of Clinical Trials (Project, Program and Development Grants) Through Project, Program and Development grants, NHMRC has provided grants for research which involves the conduct of clinical trials: Year commenced No. of grants Grant total 2008 50 $58,375,543 2009 71 $52,536,873 2010 72 $59,628,193 2011 107 $78,469,141 2012 118 $152,200,818
The National Approach (HoMER) and CTAG
• HoMER: – A body of work, including the development of a National Certification Scheme for ethical review processes, to enable the recognition of a single ethical review of multi-centre human research within and/or across Australian jurisdictions. • National Approach to Single Ethical Review – The implementation of the tools and guidelines developed under the HoMER initiative via a system of mutual acceptance of single ethical review.
The National Approach applies to all human research Health and medical research Human research Clinical research* Privately Publicly funded clinical funded clinical trials trials *Not to scale
National Approach to Single Ethical Review • Private hospitals, universities and research institutes can accept a single ethical review outcome from a NHMRC Certified Institution. • Processes of 44 Institutions (47 HRECs) certified under a National Certification Scheme for ethical review of multi-centre human research. • Implementation of the Interstate Mutual Acceptance Scheme…..
Renewal of Certification
Renewal of Certification – NHMRC has commenced the process for renewal of certification in line with the process set out in the National Certification Scheme Handbook See more at: http://hrep.nhmrc.gov.au/certification/nomination-certification – NHMRC is also proceeding with changes to its reporting requirements for HRECs to reduce duplication for Certified Institutions
Implementation of the recommendations in the Clinical Trial Action Group (CTAG) report (2011)
Recommendation A: Adoption of HoMER for clinical trials in public hospitals : – Tools and guidance material developed – National Certification scheme (44 institutions) – Standardised forms eg. PICFs/PISCs – Implementation of the National Approach by States and Territories • Australian Health Ministers Advisory Council processes.
Development of a list of ‘standard items’ associated with the conduct of Clinical Trials – now being priced by IHPA (Rec. C) … Australianclinicaltrials.gov.au – a consumer-friendly clinical trials website (Rec. E) …a Clinical Trials Factsheet for consumers (Rec. H) …identification of ‘clinical trial networks’ and registries – now on Australianclinicaltrials.gov.au (Rec. I)
Recommendation B : Progress Recommendation A through University and Private hospital sector: • 2 Universities certified – Small number of private hospitals certified • Now being progressed under the new funding initiative.
Recommendations E&F : (E)Develop a consumer friendly web portal that includes information on all current clinical trials in Australia (F) Feasibility study • australianclinicaltrials.gov.au – Launched in October 2012 – Currently being enhanced • Development of a fully interactive portal – NHMRC working closely with the Department of Innovation. – Funded under current funding initiative (2013-2017)
Australianclinicaltrials.gov.au
Current and proposed improvements to australianclinicaltrials.gov.au : • Linking in searchable clinical trial information from ANZCTR • More real stories • Consideration of culturally and linguistically diverse users • Separating clinical trials registries from networks and clinical research organisations.
NHMRC role in the Australian Government’s Expediting Clinical Trials Initiative
Key components of the Initiative 1. Streamline research governance and improve research governance processes ( NHMRC ). 2. Training and education of clinical trials proponents and Research Governance Officers ( NHMRC and Innovation ) 3. Development of a web portal ( NHMRC and Innovation ) 4. Establishing standard costs for clinical trials (IHPA) 5. Incorporation of PCEHR into clinical trials (NEHTA)
Streamlining Research Governance
Streamlining Research Governance – Enhancing NHMRC’s capacity to work with states, territories and other stakeholders on a nationally consistent approach to clinical trials (addresses CTAG recommendations A,B & I) • NHMRC will work with key stakeholders to improve governance and ethics review arrangements for clinical trials in the public hospital sector. • NHMRC will also work with public and private sector organisations to streamline approval processes for clinical trials involving multiple levels of jurisdiction.
Governance – some issues identified • Communication difficulties between coordinating sites and local sites – Lack of transparency throughout the submission process • Lack of understanding or knowledge about ethics and governance processes • Inconsistency of governance process between States and between sites • Lack of sharing of best practice in Australia and how we compare globally • Resources, training…..
National forum, mapping and consultation processes.
Streamlining Research Governance Activities – Proposed National Research Governance Forum – Establish working group(s) of key stakeholders – Scoping current public hospital and public/private sector organisations governance arrangements – Engage a consultant to work with individual jurisdictions to clarify issues and find solutions to specific policy, legal and governance issues – Develop action plan with key stakeholders
Training and Education Activities Improve clinical trial conduct and timeliness of governance approvals through the provision of education and training (addresses CTAG recommendations A & B): – Conducting joint needs analysis with Innovation – Will complement the governance work – Must consider other proposed changes
Development of a national interactive web portal Improve the management of clinical trials through a pilot project to develop a national interactive web portal (addresses CTAG recommendations E,F & H): • The current website is Phase I of the portal • Phase II envisages a fully interactive portal that will aid patient recruitment, be able to report on KPIs, will communicate with existing information management systems (AU-RED and others)
Where is the portal process up to? • Largely the responsibility of Innovation • NHMRC is likely to co-ordinate the portal steering group • Need to consider the feasibility study that has already been conducted • Need to consider related sites and portals
The National Ethics Application Form (NEAF) v2 • Modules link specifically with the National Statement on Ethical Conduct in Human Research 2007 and other guidelines Current design of NEAF application Summary of Researchers / Prior Confidentially Resources Project Project Investigators / Privacy reviews Ethical Review Section: Administrative Section: • Research team • Type of research • Research sites • Benefit/Risk • Project Funding and support • Monitoring Timeline • Research participants • • Peer review • Confidentiality and Privacy • Data and Information
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