clinical trials and related initiativesdocs2.health.vic.gov.au/docs/doc... · 2015-07-23 · –...
TRANSCRIPT
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
Australian national standardsEndorsed by:
� National Health and Medical Research Council
� Australian Research Council
� Universities Australia
• 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 Australian Code for the
Responsible Conduct of 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.
$0
$20,000,000
$40,000,000
$60,000,000
$80,000,000
$100,000,000
$120,000,000
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Over the last 5 years, the average clinical trials project grant
budget was $815,000.
Clinical Trials funding through Project Grants ($m)
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
• 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
Clinical research*
Privately
funded clinical
trials
Publicly
funded clinical
trials
Human research
*Not to scale
Health and medical
research
• 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…..
National Approach to Single Ethical
Review
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
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)
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.
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 –
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…..
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
ProjectResearchers /
InvestigatorsProjectResources
Confidentially
/ Privacy
Prior reviews
Administrative Section:• Research team
• Research sites
• Project Funding and support
• Timeline
• Peer review
Ethical Review Section:• Type of research
• Benefit/Risk
• Monitoring
• Research participants
• Confidentiality and Privacy
• Data and Information
Proposed Review of NEAF
• Objectives:
– Align with the Clinical Trials Action Group (CTAG) report
recommendations
– Align with the reviews of the National Statement
– Progress enhanced project management features (cf. IRAS UK)
• Update user interface and improve usability
• Improve form logic and question paths/series
• Evaluate data export and import facilities