Clinical

Trials and related InitiativesGordon 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 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)

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

$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

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

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

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

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

gordon.mcgurk@nhmrc.gov.au

www.nhmrc.gov.au