Enabling Research Governance Capacity in Cancer Research in NSW

Angelina Catanzariti, Kirsten Legione, Rodney Ecclestone, Heidi Welberry, Carmel Edwards, Jim Bishop

Background

NSW Cancer Trials Network:• Established under NSW Cancer Plan

2007-2010• Provides a formal structure to facilitate clinical

trials in cancer throughout NSW.• Consolidates funding provided to support

cancer clinical research in NSW.• Encouraging collaboration between clinical

cancer research groups.

NSW Cancer Trials Network

NSW Cancer Trials NetworkEXECUTIVE COMMITTEE

Chair: Prof Robyn Ward

Site ReviewSub-Committee

Protocol ReviewSub-Committee

Cancer Institute NSWClinical Research Grants

Clinical Trials Partnership Grants

Quality AssuranceKendle Australia

Clinical Trial Operation and Statistical Support

NHMRC CTC

Partnership Operational Executive Committee

(POEC)

National Clinical Trials Groups - Infrastructure

Grants

Cancer Research Infrastructure Grants

AHS Clinical Cancer Research Support Grants

Area Health Service (AHS)

Networks

Clinical Trials Nurses and Data Managers Support Grants

Multi-centre Cancer Research in NSW

• Multi-centre cancer research activity reviewed for 32 trial units (2004-2006) which demonstrated:– over 65% of trials were conducted across at

least two sites in NSW; and – 30% of trials were conducted across 4 or

more sites.

Multi-centre Cancer Research Activity in NSW

Cancer Trials open to Recruitment in NSW 2004 - 2006

0

20

40

60

80

100

120

1 site inNSW

2 sites inNSW

3 sites inNSW

4 sites inNSW

5 sites inNSW

6 or moresites inNSW

Nu

mb

er

of

Tri

als

Support for Multi-centre Cancer Research

• High levels of Multi-centre research increases need for co-ordination and streamlining of processes for research governance and ethical review in NSW.

• Clinical Cancer Research Support Grant established within NSW Area Health Services providing funding for:– Director of Clinical Cancer Research (0.1FTE)– Clinical Research Regulatory Affairs Officer (1

FTE)

Clinical Cancer Research Support Grant

• Funding commenced January 2007 and provided to individual Area Health Services (AHS).

• Established as direct response to changing environment of ethics and governance in NSW.

• Roles established to facilitate and co-ordinate ethics and governance processes for cancer clinical trials within each AHS.

Clinical Research Regulatory Affairs Officers

• 1 FTE funded for each AHS.• Responsible for:

– Co-ordination of applications for single ethical review of multi-centre research,

– Co-ordination and streamlining of research governance within their AHS,

– Provides a central point of contact for all cancer clinical research within the AHS.

Supporting Streamlined Governance

• Clinical Research Regulatory Affairs Officers support implementation of NSW Health Model for single ethical review of multi-centre research.

• Provide support and a centralised approach for Research Governance Office for each AHS for cancer research.

• Provide support to individual trial units within each AHS.

Goals of the Clinical Cancer Research Support Grant

• Provision of dedicated resources to co-ordinate and streamline ethics and governance processes.

• Increase collaboration between clinical trial units within each AHS.

• Reduce time taken to have high quality cancer trials available to patients.

• Increase activity in cancer clinical trials in NSW.