CLINICAL RESEARCH IN AUSTRALIA

CLINICAL RESEARCH IN AUSTRALIA

NHMRC Clinical Research Working Group report 1 CLINICAL RESEARCH IN AUSTRALIA REPORT OF THE NHMRC CLINICAL RESEARCH WORKING GROUP November 2001

NHMRC Clinical Research Working Group report 2 Contents Membership of the Clinical Research Working Group 5 Foreword 7 Principal recommendations 8 1 Introduction 13 1.1 Why the Working Group was established 1.2 Terms of reference 1.3 Definition of ‘clinical research’ 1.4 What the Working Group did 2 Current status of clinical research in Australia 17 2.1 Preamble 2.2 Main sources of funding 2.3 Information on clinical research activity 2.4 Information on support for clinical research 2.5 Specific recommendations 3 Clinical research training 24 3.1 Scope of clinical research training 3.2 Training expectations and needs of clinicians entering clinical research 3.3 Training program structures and curricula 3.4 Funding of clinical-research training 3.5 Specific recommendations 4 Maintaining clinical research capacity 35 4.1 Preamble 4.2 Proposal for a Clinical Practice Research Development Scheme 4.3 NHMRC clinical-research assessment processes 4.4 Clinical trials and large-scale patient-recruitment research 4.5 Clinical trials centres 4.6 Centres of Clinical Excellence 4.7 Office of the NHMRC 4.8 Specific recommendations 5 Repositories for clinical research 51 5.1 Tissue banks 5.2 Disease registers 5.3 Registers of clinical trials 5.4 Specific recommendations Appendix 1: Consultation of the health and medical research community 58 Appendix 2: Examples of clinical research initiatives undertaken 66 by professional organisations References 72

NHMRC Clinical Research Working Group report 3 NHMRC Clinical Research Working Group Membership Professor Lawrie Beilin Head, Department of Medicine University of Western Australia Royal Perth Hospital Professor Judy Black NHMRC Senior Principal Research Fellow Department of Pharmacology University of Sydney Professor John Chalmers (chair) Chair, Research Development Faculty of Medicine University of Sydney Professor Chris Del Mar Director, Centre for General Practice University of Queensland Professor Paul O’Brien Head, Department of Surgery Monash University The Alfred Hospital, Melbourne Professor Don Roberton Head, Department of Paediatrics University of Adelaide Women’s and Children’s Hospital, Adelaide Professor Tania Sorrell Professor of Clinical Infectious Diseases Deputy Head, Department of Medicine University of Sydney Associate Professor Robyn Ward Department of Medical Oncology University of New South Wales St Vincent’s Hospital, Sydney Professor John Zalcberg Director, Division of Haematology and Medical Oncology Peter MacCallum Cancer Institute University of Melbourne

NHMRC Clinical Research Working Group report 4 Secretariat Ms Elizabeth Hoole, Office of NHMRC Ms Wendy Fahy, Office of NHMRC Reporter Associate Professor Michael Frommer Deputy Director, Effective Healthcare Australia Sub-Dean (Research) School of Population Health and Health Service Research University of Sydney This report was prepared by: Michael Frommer John Chalmers Lucie Rychetnik

NHMRC Clinical Research Working Group report 5 Foreword In commissioning the Clinical Research Working Group, the National Health and Medical Research Council emphasised that its deliberations would represent the first phase in a broader continuing program of inquiry into clinical research in Australia.

The Working Group was required to limit its consideration of workforce development to issues affecting medical graduates, as the NHMRC intended to establish other working groups to examine issues affecting other professional disciplines. Therefore, in accordance with its terms of reference and the specific instructions received from the NHMRC, the Working Group restricted its consideration of clinical research workforce development, training and career structures to issues affecting medical graduates.

The Working Group conducted a very broadly-based e-mail survey of issues relevant to clinical research. The survey was distributed to researchers from all disciplines and to all other individuals on the NHMRC e-mail list server. The Working Group also sought opinions and information from a wide range of professional, academic and government bodies involved in the training, employment and career structure of medical graduates participating in clinical research. The Working Group did not consult with analogous bodies involved in the training and career development of other health professionals participating in clinical research.

It was foreshadowed that such consulation would be undertaken by a new working group set up specifically for the purpose in a second phase.

NHMRC Clinical Research Working Group report 6 Principal recommendations Recommendations in this report comprise principal recommendations 1-21, given below, and specific recommendations, given at the end of Chapters 2-5. Principal recommendations 1-2: Leadership role of the NHMRC Recommendation 1 The NHMRC should take a leadership role in the enhancement, development and support of clinical research programs, capacity and infrastructure in Australia. The Office of the NHMRC should appoint a full-time clinical academic to implement this leadership role (see Recommendation 20).

Recommendation 2 Through its leadership role, the NHMRC should resolve the current paradox whereby governments, health authorities and universities promote evidence-based practice and acknowledge the importance of clinical research that generates the evidence, but impose service workloads that prevent talented researchers from pursuing clinical research.

Principal recommendation 3: Contribution of clinical research to evidence-based practice and improvements in the safety and quality of health services Recommendation 3 Through its leadership role, the NHMRC, in partnership with other agencies, should ensure support for clinical research that underpins the development of evidence-based practice and improvements in the safety and quality of health services. Principal recommendations 4-6: Partnerships and alliances Recommendation 4 The NHMRC should recognise that the enhancement, development and support of clinical research will require collaboration, cooperation and partnerships with and between Commonwealth, State and Territory governments (especially departments of health and education), health authorities and health services, universities, professional colleges and societies, and research agencies and foundations.

Recommendation 5 The NHMRC should recognise the crucial role of academic health services in supporting or potentially supporting clinical research. The NHMRC should seek collaborations with these health services (which include teaching hospitals and non-

NHMRC Clinical Research Working Group report 7 hospital academic clinical units) to enhance the development and support of clinical research. Recommendation 6 In supporting the development of clinical research, the NHMRC should seek to work with and through existing national, State and Territory bodies such as the National Institute of Clinical Studies, the Australian Council for Safety and Quality in Health Care, and the NSW Medical Training and Education Council.

The NHMRC should encourage and facilitate the formation of similar bodies in States and Territories where these do not already exist.

Principal recommendation 7: Monitoring the status of clinical research in Australia Recommendation 7 The NHMRC should formulate criteria for classifying research-grant applications as ‘clinical’ or ‘non-clinical’, and should develop mechanisms for monitoring the extent and quality of clinical research and the capacity for clinical research in Australia. Other agencies that fund clinical research in Australia should be encouraged to use the same criteria. Principal recommendation 8: Clinical research workforce development, training and career structures for non-medical graduates Recommendation 8 The NHMRC should establish further working groups to examine clinical research workforce development, training and career structures for non-medical graduates.

Principal recommendations 9-12: Commitment to developing and maintaining the clinical-research workforce and capacity Recommendation 9 The NHMRC should take responsibility for improving and coordinating the recruitment of well-trained and talented clinical researchers, and for their retention in the research workforce.

Recommendation 10 The NHMRC should take responsibility for improving and coordinating the training of clinical researchers, recognising that this requires cooperation of many organisations that each play important but segmented roles, including universities, professional colleges and societies, health services and hospital authorities, and governments.

NHMRC Clinical Research Working Group report 8 Recommendation 11 NHMRC-funded clinical trials centres, Centres of Clinical Excellence, recipients of NHMRC program grants for clinical research, and recipients of substantial NHMRC funding for other initiatives connected with clinical research, should be required to support the training of clinical researchers and the mentoring of clinical research trainees.

Recommendation 12 The NHMRC should initiate and contribute to a national Clinical Practice Research and Development scheme, with the aim of increasing the recruitment and retention of clinician researchers in the research workforce through the progressive introduction and development of positions providing protected research time in clinical centres for fully-fledged, well-trained clinical researchers.

Principal recommendations 13-14: Enhancing the assessment of clinical research funding applications by the NHMRC Recommendation 13 The NHMRC should establish a Grants Review Panel (GRP) to assess grant applications for clinical trials and other large-scale patient-recruitment (CTLS) research. The functions of this GRP should be similar to the functions of other GRPs (or discipline panels). Like other GRPs, it should make direct recommendations for funding of research proposals. Recommendation 14 The NHMRC should substantially strengthen the clinical-research expertise represented in a number of GRPs, so that these GRPs can make balanced, well- informed assessments of the majority of applications for funding of clinical research projects.

Principal recommendations 15-16: Support of clinical trials centres and networks, and support of Centres of Clinical Excellence Recommendation 15 The NHMRC should continue, and enhance, existing programs that support clinical trials centres, and should initiate support for clinical trials networks and other collaborative clinical-research networks. Recommendation 16 The NHMRC should continue, and enhance, existing programs that support Centres of Clinical Excellence in Hospital-Based Research.

NHMRC Clinical Research Working Group report 9 Principal recommendations 17-18: Development of human tissue banks and disease registers Recommendation 17 The NHMRC should take a leadership role in a national approach to the development of human tissue banks, and should convene a regular forum to make recommendations on standardised procedures for the management and operation of tissue banks.

This forum should report to the Research Committee. Recommendation 18 The NHMRC Research Committee should take a leadership role in promoting the development of disease registers, particularly clinic- and hospital-based registers. The Research Committee should sponsor a regular national forum for methodological development of disease registers, including linkages between tissue banks and disease registers.

Principal recommendation 19: Development of a national register of clinical trials Recommendation 19 The NHMRC should take a leadership role in working with State and Territory health authorities and other agencies to foster the development of a national register of clinical trials. Principal recommendations 20-21: NHMRC infrastructure for the development of clinical research Recommendation 20 The NHMRC should immediately establish a post for a full-time clinical academic to fulfil a catalytic role in promoting and coordinating clinical research initiatives. He or she should take responsibility for the NHMRC’s initiatives in the training, recruitment and retention of clinical researchers, the provision of adequate infrastructure support, and the development of partnerships with governments, health services, teaching hospitals, universities, professional societies and colleges, and foundations.

Recommendation 21 The NHMRC should immediately increase resources available within its own Office for the support of clinical research. Unless sufficient resources are provided within the NHMRC, the recommendations of this report cannot be implemented. Core resources within the NHMRC are crucial to generate development of Australia’s capacity for clinical research.

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