Improving the Australian Clinical Trials Environment

Samantha Robertson

Executive Director

Evidence, Advice and Governance Branch

• Setting the scene for Clinical Trials Reforms

• Barriers to reform – Legal or Cultural?

• Many reforms – not all regulatory

• The Good Practice Process

Overview

1. Each year approx. $6b is invested in health R&D in Australia

– Approximately 0.4% of GDP

– 20% is in the private sector (mostly pharmaceutical R&D)

2. $1.3b is funding from the Australian Government

3. Governments are the majority funders of our public health system

Why is Government interested?

• Three reports over seven years– Pharmaceuticals Industry Strategy Group 2009

– Clinical Trials Action Group 2010

– McKeon review – April 2013

• Budget measures– 2013-14 - $9.9m over 5 years – A Plan for Australian

Jobs: Clinical Trials Reform in Australia

– 2014-15 - $9.9m over 5 years – Simplified and Consistent Health and Medical Research

Why Clinical Trials Reform?

Commonwealth

Industry

States

Territories

&

Peak bodies (MA/MTAA)

CT Networks

Sector complexity

Universities/ MRIs

Public hospitals Private/Catholic Hospitals

Patients

• Funding body

• Standard setter

• Guideline developer

• Ethics advice

• Clinical trials

• Research translation…the list goes on…….

What is NHMRC and why is it involved in clinical trials?

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Australia’s end game?

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Preferentially selected as a destination to conduct trials due to:

• Cost• Timeliness• Quality• Recruitment efficiency

But, there is much more to it than that…

• Patient centred model

• Evidence-(data)-based policy development

• Recognise the existing structures that can help us translate research

• Working together

Other important aspects to consider

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Clinical Trials Jurisdictional Working Group

– All states and territories

– Large reform agenda:

1. Establish a metrics system and promote ICT interoperability:

2. Enhance national consistency for ethics and governance:

3. Improve efficiency of recruitment and accruals:

4. Strategy for positioning Australia as a preferred location for clinical trials

A multi-jurisdictional approach

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QUICKER AND MORE EFFICIENT RESEARCH GOVERNANCE AUTHORISATION

Australia is competitive globally and delivers clinical trials of high quality

EFFICIENT ETHICS APPROVAL

INCREASED SITE READINESS AND TRANSPARENCY

BETTER TRAINED STAFF

INCREASED PATIENT RECRUITMENT AND COMMUNITY AWARENESS

What does a strong clinical trials environment look like?

What do we need to make Australia competitive?

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Quality

Transparency and Predictability

Efficiency

Collaboration

• Fragmented decision making and approvals

• Inconsistency in rules between jurisdictions

• Institutional culture and the power of myths

• Lack of single point of contact between institution and sponsor

Barriers to reform

• Quicker and more efficient ethics review and research governance authorisation:

– Good practice process for site assessment and authorisation

– Redesigned ethics application

• Better trained staff:– Learning modules for clinical trials

– Development of competencies for clinical trialists

• Increased recruitment and awareness of clinical trials

– www.AustralianClinicalTrials.gov.au

• Improved quality and transparency in clinical trials– Alignment of safety monitoring and reporting requirements

– Establishment of national scientific committees

Clinical trials work being done by NHMRC

• Long standing concern in sector

• Different views on what the problem is

• Myth? Law? Institutional culture? Distrust?

Addressing Barriers - Insurance and Indemnity

• No particular barriers, as long as the approving ethics committee is insured.

• No particular requirement that clinical trials in a public health service cannot be ethically reviewed by an external, private sector HREC….

• No insurers stipulate use of a particular HREC – public or private.

Cross jurisdictional issues regarding insurance and indemnity?

• Variation in laws across States and Territories

• Impacts on single ethical review…but

• …distinction between legal and ethical issues

• 2016 Review by NHMRC and upcoming Fact Sheets for HRECs

Guardianship and Consent Laws

• GPP developed in consultation with sponsors, researchers, institutions and other stakeholders

• Tested in a two-phase pilot:

• Phase 1 – 16 sites around Australia

• Phase 2 – 9 sites (drawn from original 16).

• GPP provides the value proposition for engagement of a CTLO

The Good Practice Process (GPP)

Impact of Clinical Trial Liaison Officer

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• Collect data to improve internal processes

• Communication

• Central contact

• ‘Shepherding’ of applications

GPP MetricsMetric Process Phase Time period measured

1a-1d Feasibility AssessmentDate the Confidential Disclosure Agreement is sent to the Principal Investigator to the date the sponsor notifies the site of site selection.

2Document Preparation

Date the sponsor notifies the site of site selection to the date valid site assessment/ethics review documentation is submitted to the institution.

3 Ethics ReviewDate a valid ethics review application is provided to the institution to the date an ethics approval notification is provided to the (Co-ordinating) Principal Investigator.

4 Site AssessmentDate a valid site assessment application is provided to the institution to the date the site assessment is finalised.

5 Site authorisationDate a valid site assessment has been finalised to the date the site authorisation is granted by the CEO or their delegate.

6First patient recruitment

Date site authorisation is granted to the date the first participant is recruited into the clinical trial.

• Collect and advertise information on sites

• Involve sponsors and CROs in meetings with sites

• Sites having sponsor evenings

• Need to work with Medicines Australia and other Peak Bodies

Working with industry

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• Many actors involvement in delivering improved clinical trial start up times

• NHMRC focusing on its strengths:

– Standard setter

– Broker

– Education

• Improvements can be driven by changes in behaviour; not just changes in legal regimes

Conclusions

• Aust CT website - www.Australianclinicaltrials.gov.au

• Twitter - @NHMRC• Twitter - @AustCT• Research Tracker - https://www.nhmrc.gov.au/media/subscription-service

• NHMRC website - https://www.nhmrc.gov.au/research/clinical-trials

Keep up to date with NHMRC Clinical Trial activities:

ClinicalTrials@nhmrc.gov.au