Victorian Comprehensive Cancer Centre Strategic Research Plan 2017-20

VICTORIAN COMPREHENSIVE CANCER CENTRE

STRATEGIC RESEARCH PLAN 2017-20

Supported by

STRATEGIC RESEARCH PLAN 2017-20

VCCC STRATEGIC RESEARCH PLAN 2017-20 | 1

CONTENTS About the VCCC

3

VCCC Strategic Research Plan 2017-20

4

Programs of work

6

Leadership and Collaboration

8

An Outstanding Cancer Workforce

11

Research Capability and Capacity

15

Expand Clinical Trials

21

Budget breakdown

31

End notes

32

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ABOUT Victorian Comprehensive Cancer Centre An alliance to advance the control and cure of cancer The Victorian Comprehensive Cancer Centre (VCCC) is a powerful alliance of 10 leading research, clinical and academic institutions with a shared commitment to saving lives through the integration of cancer research, education and patient care.

The VCCC’s multi-site, multi-disciplinary model brings together the complementary strengths of Peter MacCallum Cancer Centre, Melbourne Health (including The Royal Melbourne Hospital), The University of Melbourne, The Walter and Eliza Hall Institute of Medical Research, The Royal Women’s Hospital, The Royal Children’s Hospital, Western Health, St Vincent’s Hospital Melbourne (including St Vincent’s Institute), Austin Health (including the Olivia NewtonJohn Cancer Research Institute and Austin Lifesciences) and Murdoch Children’s Research Institute. The alliance also integrates patient and carer perspectives through formal consumer consultation processes.

The VCCC is founded on the National Cancer Institute’s Comprehensive Cancer Centre model. Under this model, research excellence is the basis for accelerating the discovery, dissemination and adoption of better ways to prevent, diagnose and treat cancer through the integration of cancer research, education and clinical care.

The VCCC alliance – and the scope, scale and depth in expertise, knowledge, practice and patient numbers it represents – provides a strategic advantage, and opportunity to drive innovation and accelerate translation of new research into treatments and care.

Vision The VCCC aims to save lives through the integration of cancer research, education and patient care. Through innovation and collaboration, the VCCC will drive the next generation of improvements in prevention, detection and cancer treatment.

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VCCC STRATEGIC RESEARCH PLAN 2017-20 What’s needed to turn research discoveries into better outcomes for Victorian cancer patients?

As Australia’s first comprehensive cancer centre, how can the VCCC speed up the process of turning cutting edge research into the future of cancer care?

This Strategic Research Plan (SRP) sets out to answer these questions. The SRP, supported by $30 million from the Victorian State Government, maps a structured approach to tackling some of the big challenges in cancer with the aim of delivering long-lasting benefits.

Over the past year, more than 200 representatives from VCCC partner organisations, external stakeholders, consumers and the community have contributed to the planning, process, design and development of this plan. As such, it represents the shared vision and purpose of people and organisations committed to working together in new and better ways towards optimising outcomes for cancer patients.

This is a plan that seeks to convert new research from knowledge to action. It’s about plugging into the potential of the alliance: collaborating, enabling, galvanising, facilitating and networking. It strategically fills gaps and capitalises on opportunities. It’s about inspiring leadership, breaking down barriers, building effective systems, advancing knowledge, and creating and embedding smarter ways of working. >> The programs in the SRP are grouped into four broad themes: Leadership and Collaboration; An Outstanding Cancer Workforce; Research Capability and Capacity, and Clinical Trials Expansion.

Just as ‘the whole is greater than the sum of its parts’, the 19 programs that form the SRP cannot be considered in isolation - each is intrinsically linked and connected to the others.

At the end of three years, success will mean: >> more clinical trials covering more cancer disciplines, and more patients getting the opportunity to participate in trials and clinical research >> greater capacity and capability of the cancer workforce >> new collaborative programs in cutting-edge areas of cancer research, such as immunotherapy, targeted therapies, precision prevention and tailored screening. >> effective leadership across the alliance and a culture of collaboration embedded at an organisation level >> faster translation of research advances into standard care for patients with cancer.

Together, these achievements will ensure promising cancer research can move rapidly from potential to reality in the form of better treatments, practice, policy and care. By 2021, Victorians will be experiencing the benefits of a world-class, future-ready comprehensive cancer centre.

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How can the VCCC turn research discoveries into better outcomes for Victorian cancer patients?

$30 MILLION

50+ CONSULTATIONS

200+ CONTRIBUTORS

investment by State Government of Victoria

Representing all cancer disciplines as well as cancer patients and carers.

Active, collaborative, inclusive co-design process:

IDENTIFY NEEDS

SET GOALS

COLLECT IDEAS

AGREE PRIORITIES

SHARE AND ENGAGE

PLAN, BUDGET

TEST, REVISE AND REVIEW

DESIGN PROGRAMS

The Result 19 programs aligned to four interconnected themes OUTSTANDING CANCER WORKFORCE

CLINICAL TRIALS EXPANSION RESEARCH CAPABILITY AND CAPACITY

LEADERSHIP AND COLLABORATION

One Strategic Research Plan > Prioritising activities that cannot be done by individual VCCC partners alone > Targeting opportunities to complement and expand on existing work > Focusing on areas of unmet need

One shared goal

TURN EXCELLENT RESEARCH INTO BETTER OUTCOMES FOR VICTORIAN CANCER PATIENTS

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PROGRAMS OF WORK The 19 programs that make up this Strategic Research Plan have been grouped into four broad themes: Leadership and Collaboration, Outstanding Cancer Workforce, Research Capacity and Capability and Clinical Trials expansion. The programs are, however, intrinsically interconnected and most span other themes. The overall Strategic Research Plan should be considered as a whole, ultimately working towards one clear goal: better outcomes for Victorian cancer patients.

IMMUNOTHERAPY

✓ New collaborative programs in cutting-edge areas of research

PRECISION PREVENTION AND TAILORED SCREENING

UNDERSTANDING RESPONSE AND RESISTANCE TO TARGETED THERAPIES

RE AND LEAD

BUILDING CONNECTIVITY

PRECISION ONCOLOGY

✓ Faster translation of research into care

✓ Greater capacity and capability of the cancer workforce

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ON BUILDING ANALYTICAL CAPABILITY FOR DATA DRIVEN RESEARCH

B N RE CA

✓ Effective leadership and culture of collaboration

BUILDING CAPACITY THROUGH EFFICIENCY INVESTIGATORINITIATED TRIAL CAPACITY BUILDING

ESEARCH EDUCATION D PROGRAM

TELETRIALS

BUILDING TRIAL GROUP CAPABILITY

REGISTRY TRIALS METRICS FOR CLINICAL TRIAL PARTICIPATION

INCREASING AWARENESS OF CLINICAL TRIALS

NE GOAL Better outcomes for Victorian cancer patients

BUILDING NURSING ESEARCH APABILITY MASTERS OF CANCER SCIENCES

INCREASING ADOLESCENT AND YOUNG ADULT CLINICAL TRIAL ACCESS

NEW APPROACHES TO CLINICAL TRIALS DEVELOPMENT OF CLINICAL TRIALS WORKFORCE CAPACITY AND CAPABILITY

✓ Expanded clinical trials and increased patient participation

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LEADERSHIP AND COLLABORATION Leadership and collaboration are fundamental to what the VCCC does, and the way that it works.

In a comprehensive cancer centre setting, leadership means the ability to harness collective effort to achieve maximum gain, and build networks of knowledge and expertise to tackle the most difficult clinical challenges. It requires working democratically across organisational boundaries while raising the bar of expectation and achievement.

Similarly - at an organisational level - effective collaboration must be strategic and insightful, offering benefits for all participants, providing the opportunity to achieve much more than one group or organisation could do alone.

The two programs in this section are flagship programs that are both representative of the nature of the alliance and critical to the success of the SRP.

>> Research & Education Leads >> Building Connectivity Theme Focus For communication purposes, the SRP programs are grouped into the four broad themes. As the programs are interlinked and most have elements of multiple themes, the Focus Theme bar indicates the proportionate emphasis of each program against the themes.

Theme Focus Key

Leadership and Collaboration Outstanding Cancer Workforce Research Cabability and Capacity Expand Clinical Trials

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Research & Education Lead Program

Investment $4.2 Theme Focus

The Program: The Research & Education (R&E) Lead Program will systematise collaboration across the VCCC to turn the idea of integration of research, education and clinical care, into reality.

area across the VCCC. The Research & Education Lead program already has six established Leads, with a further six to be introduced as part of this program.

Key elements of this program include:

Phase i) Development of an evidence-base to inform and support collective planning through a mapping exercise and engagement with relevant healthcare professionals, researchers and educators across all partner sites.

>> building leadership and networks for tumour streams and selected cancer themes across the VCCC >> expand reach of the tumour stream/cancer theme through needs-based educational programming.

Rationale This program manifests the foundational principles of the VCCC by systematising and normalising collaborative activities across the VCCC partners.

The program addresses a significant proportion of the priorities for the VCCC, leading to integration of research, education and clinical care; sharing of ideas and knowledge to improve patient outcomes; and facilitating shared education and training across member organisations.

Goals >> Better leadership and strategic direction for research and education. >> Integrate research, education and clinical aspects of tumour streams or cancer themes. >> Embed international and local research and evidence into clinical practice. >> Increase the impact, breadth and depth of research relevant to the cancer theme. >> Add value to education programs that underpin excellence in clinical care and research. >> Facilitate better use of integrated research and clinical data. >> Enable multi-site clinical trials.

Once a Lead is appointed, there are three phases of activity in the program:

Phase ii) Development of an agreed, strategic VCCCwide direction for the tumour stream or cancer theme, with a focus on creating new networks and other ways to enable transfer of knowledge.

Phase iii) Dissemination of knowledge and evidence to integrate research, education and clinical care and facilitate practice change across the VCCC. Research and Education Leads will also have key roles in a number of programs that require leadership and expertise.

Key measures of success: Measures of success will be tailored for each tumour stream or cancer theme and include: >> measures of engagement >> impact of research meetings and educational activities >> measures of consensus on strategic direction and important clinical challenges >> numbers and impact of collaborative activities >> measures of practice change.

This program is designed to build leadership capability to enhance knowledge translation and collaboration leading to greater collaborative research and better integration of research and education into clinical care.

Activities include Appointing senior clinician-scientists as Research & Education Leads to develop and harmonise high quality, research and educational activities within their specialty

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Building Connectivity

The Program: Actively build and enhance connections, networks, and groups to support sharing of knowledge and growing trans-disciplinary collaborations in key areas of interest.

The key elements of the Building Connectivity program are: >> establish groups in at least three priority areas of focus >> use lessons from these initial areas, plus a review of international best practices, to develop the framework, processes and resources required to enable connectivity across the VCCC.

Rationale Consultations across the alliance have consistently highlighted the need for a coordinated approach to help bring together individuals with shared interests.

By facilitating these connections, researchers and clinicians across the partnership will have the opportunity to share, learn, identify and solve problems and ultimately, improve outcomes for patients. Effective connections and communication among groups with similar or complementary interests will be central to enabling the VCCC alliance to realise its potential, by ensuring the best minds in cancer care are working together.

Goals >> Build connectivity and networks that reduce organisational boundaries to enable strategic and systematic collaboration. >> Develop the capability and processes that will enable effective connections between organisations, disciplines and research specialities.

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Investment $620,000 Theme Focus

Activities include >> Setting up and supporting the connection of the initial groups. >> Providing support for face-to-face activities such as meetings, targeted professional development, forums and preceptorships. >> Consultation with potential new and emerging groups to assess the opportunities for collective gain within this program. >> Identification and development of resources and/ or infrastructure such as mentoring resources and other enablers, to address identified group needs and enhance connectivity. >> Utilise lessons and best practice processes to enable tailored connectivity for new and emerging groups.

Key measures of success: >> establishment of active and engaged groups within the VCCC partners >> measures of engagement such as numbers of meetings/ activities and numbers of participants >> number of groups that achieve the goals or outcomes that they define >> awareness of the value and utility of the connecting role of the VCCC, evidenced by requests for assistance with connectivity.

As an alliance organisation, the VCCC’s ability to develop and implement effective processes that build and foster connectivity will be central to achieving our mission.

AN OUTSTANDING CANCER WORKFORCE A highly skilled and capable cancer workforce is essential to research excellence and high-quality, patient-centred care.

In addition to filling clearly identified gaps, needs and opportunities in education and training, these programs will further develop the strong, adept and flexible cancer workforce required to keep pace with rapidly advancing research and future needs.

>> Masters of Cancer Sciences >> Development of Clinical Trials Workforce Capacity and Capability >> Building Nursing Research Capability

Theme Focus Key

Leadership and Collaboration Outstanding Cancer Workforce Research Cabability and Capacity Expand Clinical Trials

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Masters of Cancer Sciences

The Program: Development of a wholly online, contemporary, evidence-based suite of graduate programs in research, education and care for health professionals who care for cancer patients.

Key elements of this program include: >> a fully flexible online elective program delivered through a combination of online courses, webinars and interactive digital workshops >> a nested program that provides qualification points at the Specialist Certificate, Graduate Certificate and Masters level >> a multidisciplinary program for cancer clinicians from the fields of surgery, radiation oncology, medical oncology, haematology, nursing, allied health and other health professions.

Rationale The Master of Cancer Sciences will be the first cancerspecific, multidisciplinary and wholly online Master’s program offered in Australia and one of two available in the world. Positioning the VCCC as a centre for educational excellence, graduates will contribute to a world class workforce that improves the experience and outcomes of cancer patients.

The development of customised postgraduate education and training has been consistently identified as a need across the VCCC and is a requirement of the VCCC core funding and Strategic Research Plan Funding Agreement 2016-20. It also aligns with the strategic objectives of becoming a leading national and regional centre for cancer education and training that fosters a skilled, high calibre, sustainable workforce in Victoria to meet the demands of future cancer control.

Investment $600,000 Theme Focus

Goals >> An education and training program that contributes to building the future cancer workforce for Victoria, and more broadly across Australia and internationally. >> Recognition of the VCCC as the pre-eminent cancer education and training institution in Australia. >> A postgraduate program that is sustainable through online delivery and fee-based cost recovery. >> Ability to repurpose content for ongoing professional development activities that may provide opportunities for broadening educational reach and revenue streams.

Activities include >> Identifying and appointing course and subject coordinators. >> Comprehensive 12-month process of planning, content-writing, recording, post production, delivery and evaluation. >> Successive development of the ten subjects that comprise the elective subject list to be rolled out progressively thereafter.

Key measures of success: >> number of participants enrolled, and cross enrolment, conversion, retention and completion statistics in the specialist certificate, graduate certificate and masters of cancer sciences >> number of course development coordinators, subject development coordinators, working party members, assessors, and markers involved in the development and delivery of the program >> student and faculty satisfaction surveys measuring the quality of the program from the perspective of the participants and faculty.

The VCCC investment in the Masters of Cancer Sciences will position the VCCC as a centre for excellence in cancer teaching and learning in Australia and internationally.

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Development of Clinical Trials Workforce Capacity and Capability

Investment $1.8m Theme Focus

The Program Development and delivery of a cancer clinical trials education and professional development program which will contribute to establishing a highly trained clinical trial workforce capable of meeting the demand for increased clinical trial activity across VCCC, the state and nationally.

Goals

Key elements of this program include:

>> key cancer clinicians and trial managers who have advanced skills such as the business management and business development aspects of the clinical trial system

>> a granular needs analysis of clinical trial workforce education, training and professional development >> competency frameworks for key sections of the clinical trial workforce >> developing education and training offerings to address unmet needs and upskill the workforce to have the competencies required to enable increased clinical trial activity.

Rationale A key focus of the SRP is the expansion of clinical trial activity, meaning more patients will be enrolled in clinical trials. There is, however, a recognised deficit in the highly-trained clinical trial workforce needed to support this increased clinical trial activity.

Currently, there are no professional development pathways supported by a recognised, best-practice education program for the clinical trial workforce.

This program will develop the education and training programs required to fill unmet needs and support the development of a skilled clinical trials workforce within the VCCC.

Develop a capable and competent VCCC cancer clinical trials workforce including: >> more research nurses with the skills to support and coordinate clinical trials >> more cancer clinicians with the skills and experience to be investigators on clinical trials

>> more scientists with the skills to be study coordinators.

Activities include >> Mapping of the clinical trials workforce across the VCCC and regional Victoria. >> Mapping and needs analysis of current education and professional development available to the workforce to identify gaps and unmet needs. >> Development of competence framework to guide development and delivery of education and training programs. >> Development and delivery of education and training programs.

Key measures of success: >> number of education and training programs developed >> attendance at education and training programs >> number of staff trained.

The VCCC’s investment in development of workforce capacity and capability will facilitate expansion of clinical trial activity.

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Building Nursing Research Capability

The Program Development of cancer nursing research capability that has potential to enhance patient care, health outcomes and health services efficiency.

The key element of this program is the development of research literacy and capability among cancer nurses, centred around a VCCC nursing research innovation hub, that will result in greater nurse-led clinical research activity across the VCCC, Victoria and Australia.

Rationale A nursing workforce that is skilled and active in research is a fundamental component of a truly comprehensive cancer centre (CCC). However, both locally and internationally, the essential contribution of nursing knowledge to the practice, education and research objectives of a CCC has been largely overlooked.

The majority of a cancer patient’s time is spent with nurses, and nurses form the largest component of the health workforce in metropolitan, regional and rural areas. Rigorous nursing research activity in areas such as access to and equity of care; symptom and side-effect management; efficient models of care, and post-treatment care, has considerable potential to positively impact cancer patient care and health outcomes. Committing to the growth and development of academic cancer nursing will set the VCCC apart in an international context.

Investment $1.0m Theme Focus

Goals >> Grow academic leadership in nursing research and create a point of connectivity and research mentorship for nurses from across Victoria. >> Increase capability of nurses to integrate evidence into routine practice and to lead health services research in all aspects of care including clinical trials. >> Develop a research culture among VCCC cancer nurses and through this systematically improve hospital-based service delivery and consequently improve patient experience and outcomes.

Activities include >> Design and establishment of the VCCC nursing research innovation hub incorporating: ¬¬ academic and nurse clinician-researchers; ¬¬ a supportive training and mentorship structure for cancer nurses conducting research; ¬¬ seed funding for nurse-led research projects; ¬¬ a central point for nurse-led cancer research, to maximise impact. >> Management of the hub by a Program Manager who will promote the activities, coordinate access to educational programs and evaluate the structure and function of the hub for continuous improvement.

Key measures of success: >> measures of engagement including numbers of participants in the various activities of the hub >> numbers of nurses taking up activity-based research training programs and bringing forward new ideas and projects >> growth overall of nurse-led projects of all types, funded and published cross-institutional collaborative programs, and clinical impact on patient experience and outcomes.

The VCCC nursing research innovation hub will actively support and train the cancer nurse research leaders of the future.

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RESEARCH CAPABILITY AND CAPACITY Collectively, the VCCC alliance is Australia’s largest and highest impact cancer research program. The Strategic Research Plan seeks to build capacity and accelerate translation in areas of research strength, and build new capability where it is needed for a truly comprehensive cancer research program.

A systematic, academic program of outcomes-focussed health services research is one way of reducing the impediments to the highest standards and latest advances in healthcare being available for cancer patients. The first program in this section is focused on building infrastructure and new capability in cancer health services research.

The other four programs in this section capitalise on the strengths in cancer biology across the VCCC to accelerate translation into clinical practice. These programs complement VCCC partners’ clinical strengths in early phase trials, imaging and prevention.

Together these programs aim to help close the gap between the VCCC’s research excellence and areas of need in clinical practice.

>> Building Analytical Capability for Data Driven Research >> Precision Prevention and Tailored Screening >> Understanding Response and Resistance to Targeted Therapies >> Immunotherapy >> Precision Oncology >> Theme Focus Key

Leadership and Collaboration Outstanding Cancer Workforce Research Cabability and Capacity Expand Clinical Trials

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Building Analytical Capability for Data-driven Research

The Program Making better use of existing health data by testing and validating ways to utilise retrospective health data that is already collected and stored electronically.

Key elements of this program include: >> a platform that facilitates sharing of, and access to, VCCC and external cancer health data for research. >> building cancer health services research and datadriven clinical research >> bringing together data sciences and clinical expertise.

Rationale Sharing health data and data-driven research have been frequently cited as priorities for the VCCC partnership, while independent evidence shows that health data usage represents a major capability gap in Australian health and medical research. The VCCC alliance provides an ideal environment in which to test a model for access, linkage and analysis of health data for research.

The dearth of health services research highlighted in the McKeon Report and the lack of integration across healthcare sectors (including primary care) in Australia, compound to result in less than optimal health and wellbeing outcomes. With direct access to recordlinkable hospital data and both university and hospital partners, the VCCC is well positioned to build a platform suitable for data-driven research as well as a systematic, academic program of outcomes-focused, data-driven health services research.

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Investment $1.3m Theme Focus

Goals >> Establish a platform for sharing and accessing health data that can grow, is flexible and meets researchers’ needs. >> Increased data-driven cancer research (including health services research, health economics, clinical research and patient outcomes-focussed research) that will: ¬¬ impact patient outcomes and efficiency of health services; ¬¬ influence health policy and practice.

Activities include >> Completing and maintaining linked VCCC administrative datasets, and add a range of other datasets such as VCCC hospital costing data, primary care data, Victorian Cancer Registry data and relevant VCCC clinical datasets. >> Developing a data-driven research hub to improve data access for researchers.

Key measures of success: >> establishment of a useful and active data-driven research hub that facilitates health services research >> growth in collaborative and cross-disciplinary health services research activity and impact >> numbers of new clinical datasets and registries contributed to the platform.

Sharing health data and data-driven research will grow high-quality health services research that can positively influence health service delivery and patient outcomes.

Precision Prevention and Tailored Screening

The Program Support for the development of strategies and activities to enable precision prevention and tailored screening.

The key elements of this program are: >> bring together expertise in this area, improve coordination and identify opportunities for collaboration >> develop consensus on a collaborative program of work that enhances research translation and impact.

Rationale Precision prevention is defined as prevention that is specific to an individual, while tailored screening considers an individual’s risk profile when determining the best approach to screening for cancer. Prediction of people’s future cancer risk (risk prediction) is a key component of both precision screening and prevention because it enables tailored screening programs and targeted prevention programs.

Over the past 20 years, research on personal risk of some common cancers has led to the development of risk models that can classify individuals into cancerrisk strata. However, risk prediction models and new evidence on best practice for risk-stratified screening are not routinely translated into clinical practice or public health policy. Cancer screening programs that are targeted at high-risk individuals will have improved benefits and reduced harms, as well as increased costeffectiveness.

VCCC expertise in precision prevention and tailored screening is not currently well-coordinated, and increasing connectivity improve this to expedite translation of research.

Investment $800,000 Theme Focus

Goals >> Develop an agreed program of work in the field of precision prevention and tailored screening. >> Translation of suitable existing risk prediction methods or models closer to routine prevention and/ or screening guidelines or practices. >> Increase translational research activity across the VCCC for research into precision prevention and tailored screening.

Activities include >> Facilitating connection of groups with complementary expertise that want to develop risk stratified prevention studies and/or tailored screening trials, to explore relevant existing research, and develop plans for future prevention and screening studies. >> Activities for developing consensus on what is required to support precision prevention and tailored screening activities and/ or translation of relevant research closer to routine practice.

Key measures of success: >> consensus across the VCCC partners on a strategy and approach to improve precision prevention and tailored screening >> implementation of a program of work that provides the greatest value-add for the VCCC partner organisations and the broader community.

This investment in precision prevention and tailored screening will grow an area that currently has low translational research investment and activity, yet holds great potential to reduce the burden of cancer.

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Understanding Response and Resistance to Targeted Therapies

Investment $940,000 Theme Focus

The Program Enable and support research that will improve understanding of the biological basis of resistance and super-response to targeted therapies being explored in clinical trials at the VCCC.

Goals

Key elements of this program include:

>> More frequent use of PET imaging for assessing response in early phase clinical trials.

>> Create new capability and capacity in key platform technologies for biomarker assays. >> Integrate Positron Emission Tomography (PET) molecular imaging data uniformly into assessment of response and resistance to targeted therapies in early phase clinical trials. >> Systematise and streamline targeted patient sample collection and distribution.

Rationale Matching the correct targeted therapies to individual patients is a major challenge. While targeted therapies hold the key to improved outcomes for patients being treated for cancers with a poor prognosis, patient selection remains the major barrier - especially in cancer types where only a small proportion of patients have durable responses to targeted therapies.

This program capitalises on strengths in VCCC partner organisations in early phase trials of targeted therapies, PET imaging, cancer biology and cutting-edge analytical platform technologies. Connecting and developing existing expertise and facilitating greater use of PET imaging to assess response and/or resistance to targeted therapies in clinical trials will add value to the current resources.

>> More patients accessing the right novel targeted therapies in clinical trials. >> Enhanced expertise across the VCCC in targeted therapies, their clinical use and the latest techniques for predicting and assessing response to treatments.

>> Position the VCCC alliance as a global leader in international efforts to understand response and resistance to targeted therapies, capitalising on its competitiveness in early phase clinical trials.

Activities include >> Developing processes to enable samples from clinical trial patients to be assayed for biomarkers of response and/or resistance to targeted therapies >> conducting biomarker assays using key analytical platform technologies. >> Accrediting PET facilities at St Vincent’s Hospital Melbourne and Western Health to enable their use for clinical trials. >> Appointment of new roles in physics, statistics and data management to increase capacity for use of PET in clinical trials. >> Conducting focussed annual scientific symposia to grow expertise in targeted therapies.

Key measures of success: >> number of collaborative projects between researchers working with specialist analytical technologies and clinicians researching response and resistance to targeted therapies >> number of targeted therapy clinical research projects utilising biomarker assays >> number of PET instruments accredited to contribute to clinical trials >> number of targeted therapy clinical trials utilising PET imaging.

This program will improve understanding of response and resistance to targeted therapies and allow more patients to benefit from receiving the right novel therapies.

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Immunotherapy

Investment $1.1m Theme Focus

The Program Increased application of techniques from fundamental- and tumour immunology research to the clinic.

Key elements of this program include: >> leadership for the new Centre for Immunotherapy* >> support for a VCCC Virtual Translational Immunobiology Laboratory.

Rationale Immunotherapies are a new class of anti-cancer therapy that have the potential to change the way cancer is treated. The VCCC partners already have internationally competitive research programs in fundamental immunology and tumour immunology however Australia currently lags behind its international counterparts in clinical use of immunotherapies.

The biggest clinical challenge in the field is identifying which patients will benefit from different immunotherapeutic agents (alone and in combination with other therapies) and understanding the biology behind these benefits.

Activities include >> Appointing Centre for Immunotherapy* staff (Director and Laboratory Manager). >> Leading development of an integrated immunotherapy research and clinical program designed to maximise collective gain. >> Facilitating access to existing research platforms to conduct assays for immunotherapy clinical trials and clinical research in the VCCC Virtual Translational Immunobiology Laboratory.

Key measures of success: >> number of immunotherapy-related collaborative projects, research grants and clinical trials >> numbers of clinical trials and clinical research projects utilising assays provided by the virtual laboratory.

This coordinated, collaborative immunotherapy program will increase and improve patient access to clinical trials in this rapidly evolving area of research and treatment.

Coordination of existing research expertise and infrastructure will increase use in clinical studies and clinical trials of immunotherapies.

Goals >> More patients, with more types of cancer, having the opportunity to benefit from immunotherapies. >> Better integration of existing laboratory and clinical research expertise. >> Greater collaboration between laboratory-based immunology researchers and cancer clinicians. >> More clinical trials of novel immunotherapies.

* The Centre for Immunotherapy on Level 13 of the VCCC building will house 60 laboratory-based scientists plus dry-lab researchers and support collaboration with cancer immunology researchers across the VCCC alliance.

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Precision Oncology

Investment $1.5m Theme Focus

The Program Bringing next-generation genomic technologies closer to the clinic through increased integration of patients’ genomic data into routine clinical decision-making.

Key elements of this program include: >> a system to request genomic assays for those patients who are most likely to benefit >> standardised interpretation and reporting of genomic pathology data >> integration with clinical trials of therapies matched to genetic lesions, particularly n=1 trials via the New Approaches to Clinical Trials program (p 22).

Rationale The principle of precision oncology is to ‘give the right drug to the right patient at the right time’ by using genomic profiling of the tumour to guide treatment.

Next-generation genome sequencing technologies are increasingly used in clinical research and patient selection for clinical trials, but are not yet well integrated into routine clinical practice.

This program builds on the VCCC partners’ existing genomics expertise and infrastructure including the University of Melbourne Centre for Cancer Research’s platform for whole genome sequencing and Peter Mac’s Comprehensive Cancer Panel, as well as the wellestablished VCCC Molecular Tumour Board.

Goals >> Greater consensus on the optimal application of different genomic pathology tests. >> Genomic tumour profiling for patients who are most likely to benefit in a clinically useful timeframe. >> More cancer clinicians skilled in the use and interpretation of genomic pathology.

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Activities include >> Developing and testing of a system to request genomic tests for patients most likely to benefit, including criteria and processes for referral. >> Appointing two curation scientists to provide extra resources for curation of genomic data and to analyse the data in a clinically useful timeframe.

These curators will work at both Peter Mac and the University of Melbourne Centre for Cancer Research. >> Appointing of a medical oncologist to provide clinical input into the reporting of genomic pathology data to referring clinicians and the VCCC Molecular Tumour Board as required. >> Refining of the operations of the VCCC Molecular Tumour Board to align with new referral/request systems and standardised reporting so that genomic pathology, computational oncology and clinical care are integrated. >> Genomic testing for a limited number of cancer patients for whom there is good evidence for an expectation of clinical benefit, but for whom testing is not yet reimbursed and a suitable research study is not available.

Key measures of success: >> number of referrals for genomic testing >> number of reports on genomic data in a clinicallyuseful timeframe.

The VCCC investment in precision oncology will expedite integration of patients’ genomic data into routine clinical decision-making.

EXPAND CLINICAL TRIALS As a critical bridge between research discoveries and new treatments and care, clinical trials are a key feature of the comprehensive cancer centre model and this plan.

The programs outlined here represent a cohesive multi-pronged approach to deliver an expanded clinical trial portfolio. There are strong emphases on building capability in currently underserved areas; increasing access for patients across Victoria, and developing metrics to improve measurement and evaluation.

The programs target areas in which the VCCC has the potential to add the greatest value, while leveraging the efforts of the many organisations already working towards improvements in clinical trials. Underpinned by the plan to build the capacity and capability of the clinical trials workforce, these programs will ensure that more Victorians are participating in cancer-related clinical trials.

>> New Approaches to Clinical Trials >> Registry Trials >> Teletrials >> Increasing Awareness of Clinical Trials >> Increasing Adolescent and Young Adult Clinical Trial Access >> Building Trial Group Capability >> Building Capacity Through Efficiency >> Investigator-Initiated Trial Capacity Building >> Metrics for Clinical Trials Participation

Theme Focus Key

Leadership and Collaboration Outstanding Cancer Workforce Research Cabability and Capacity Expand Clinical Trials

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New Approaches to Clinical Trials

Investment $680,000 Theme Focus

The Program This program provides an option to treat patients in instances where genomic pathology identifies an actionable mutation (genetic lesions that indicate a likely response to a targeted therapy) however a suitable clinical trial is not currently recruiting.

Goals

The key element of this program is the set up and implementation of an N=1 trial.

>> Developing and writing a protocol for N=1 trials.

Rationale An N=1 trial is a novel trial design suited to precision oncology, providing an option for patients with an actionable mutation to access a targeted therapy. This new approach to trial design provides a framework to perform a preliminary evaluation of response to new therapies and to investigate predictors of response and mechanisms of resistance through biomarker evaluation.

>> More options for participation in matched-therapy clinical trials for patients who have had genomic testing and been found to have actionable mutations.

Activities include >> Establishing a framework for N=1 trials. >> Developing and agreeing new consent, ethics and governance processes required for efficient Implementation of multi-site precision oncology trials. >> Developing agreements with pharmaceutical companies for access to targeted therapies.

Key measures of success: >> approval of trial protocol >> number of molecular targets covered by accessed therapies >> number of patients discussed through the Molecular Tumour Board enrolled onto an N=1 trial.

Of the new genomics-based approaches to trial design being used in oncology, N=1 trials are the most applicable for the VCCC, due to the design of the precision oncology program.

22 | VCCC STRATEGIC RESEARCH PLAN 2017-20

Registry Trials

Investment $1.8 m Theme Focus

The Program Prospective registry-based randomised controlled trials (registry trials) are a new clinical trial design that offers the potential for large numbers of patients to participate in clinical trials.

Goals

The key elements of this program are:

>> Greater understanding across disciplines of which trials and which questions are feasible for registry trials, and more clinicians capable of conducting them.

>> conducting a set of demonstration registry trials >> analysis of the critical success factors for the registry trial methodology in the oncology setting and the design of clinical registries that enable registry-based trials >> dissemination of findings to increase impact of the program.

Rationale Registry trials are a cost-effective methodology for randomised interventional trials with large numbers of enrolled patients, providing the opportunity to cost-effectively answer pragmatic but important clinical questions. Generalising results from traditional randomised clinical trials involving restricted and relatively small patient numbers is problematic. Because registry trials enrol real-world patients from routine clinical practice the results can inform, and be quickly translated into, routine clinical care.

An in-depth academic assessment of the critical success factors required to enable registry-based trials has been included because registry trials are not yet commonly used in oncology. Therefore the efficacy, efficiency and quality of the registry-based trial approach needs to be demonstrated in the oncology setting to increase uptake. Understanding and sharing these critical success factors to upskill investigators will be essential to building sustainable capability in the conduct of this novel trial type.

>> Establishment of registry-based trials as a common trial methodology. >> High patient participation rates in registry trials for both common and uncommon cancers.

>> more clinical registries at a standard suitable for use in registry trials.

Activities include >> Demonstration trials in three different tumour streams, using registries at different stages of maturity. Each trial will be designed to answer pragmatic clinical questions in both common and rare cancers. The aim is for two trials to be opened per tumour stream. >> Assessing the critical success factors for both trial design and methodology, and registry design and quality. >> Dissemination activities to inform investigators how to successfully conduct registry trials.

Key measures of success: >> successful evaluation of initial registry trials >> number of patients recruited in registry trials >> increased knowledge about why, when and how to conduct registry trials.

Broadening the VCCC portfolio to include new trial types such as registry trials creates the opportunity for more clinical trials and greater patient participation.

VCCC STRATEGIC RESEARCH PLAN 2017-20 | 23

Teletrials

Investment $1.5m Theme Focus

The Program Use of tele-health technology to provide rural and regional Victorians with the opportunity to have more cancer clinical trial-related treatment closer to home.

The key elements of this program are: >> appointment of VCCC Regional Oncology Leads to support building partnerships and networks with regional cancer services

Goals >> Improved access to, and increased participation in, cancer clinical trials for patients living in regional and rural Victoria. >> Reduced burden of participation in cancer clinical trials – including time, cost and social disruption – for patients living in regional and rural Victoria.

Activities include

>> implementation and evaluation of pilot teletrials.

>> Appointing a VCCC Regional Oncology Lead and Deputy Regional Oncology Lead (September 2017).

Rationale

>> Implementing a first tranche of pilot teletrials with attention to:

Compared to metropolitan Melbourne, proportionally fewer patients from rural and regional Victoria participate in cancer clinical trials. The key barrier to equitable access to clinical trials for rural and regional cancer patients is the cost and time required to travel to Melbourne to participate. Inequality in clinical trial access is a factor in poorer cancer outcomes for regional Victorians.

Teletrials enable rural and regional patients to maximise the proportion of their trial-related treatment that is closer to home, offering the potential to reduce the burden of trial participation without compromising safety. Teletrials complement regional clinical trial networks by providing patients with access to clinical trials that are not open at regional hospitals.

¬¬ selection of primary and satellite sites ¬¬ governance and regulatory considerations ¬¬ engagement of trials groups/drug companies and selection of trials. >> Undertaking a process evaluation to inform the design of the second tranche of teletrials. >> Testing a more complex cluster model with multiple teletrial sites in the second tranche of teletrials.

Key measures of success: >> number of rural/regional patients recruited to a teletrial >> number of eligible regional patients participating in a metropolitan clinical trial via tele-health >> number of investigators and healthcare professionals with greater knowledge or experience of conducting teletrials.

Establishing teletrials will improve clinical trial access and participation for patients living in regional and rural Victoria.

24 | VCCC STRATEGIC RESEARCH PLAN 2017-20

Increasing Awareness of Clinical Trials

The Program More opportunities for patient participation in clinical trials through increased awareness of trials that are actively recruiting.

The key elements of this program include: >> a feasibility study of real time updates to the Victorian Cancer Trials Link (VCTL) website and app >> a coordination resource to supplement the VCTL clinical trial app and website to streamline awareness of actively-recruiting Phase 1 trials.

Rationale As the main source of clinical trials information for many patients, treating clinicians are key to patient awareness of actively-recruiting trials.

Information about actively recruiting trials is often out of date, creating a barrier to awareness and recruitment.

Provision of real time information, with automatic updates to the VCTL platform, should provide reliable and accurate information for patients and clinicians, consequently increasing awareness of actively recruiting clinical trials.

In addition, awareness of open Phase 1 trials presents a distinct challenge, as their status changes particularly rapidly therefore requiring a hands-on approach to ensure seamless patient referral to major Phase 1 sites.

Investment $900,000 Theme Focus

Activities include Feasibility study of real time updates to the VCTL clinical trial website and app: >> Establishing a partnership with Cancer Council Victoria team who have developed the VCTL platforms. >> Testing the feasibility of automated, real time updating of VCTL clinical trial status data from at least two VCCC sites.

Coordination of patient referrals between three Phase 1 sites: >> Employing coordinators to facilitate seamless patient referral to Phase 1 sites and coordination of molecular testing for trials with rare molecular subtypes.

Key measures of success: >> number of eligible patients who have clinical trial participation offered and discussed with them >> number of patients being pre-screened for Phase 1 studies >> number of patients enrolled in Phase 1 trials.

Efficient, practical improvements and upgrades to current systems and tools will increase awareness of actively-recruiting clinical trials.

Goals >> Continued improvements to support greater usage of the VCTL website and app. >> Improved participation in clinical trials. >> Better recruitment to Phase 1 trials through improved coordination of referrals for all Victorian patients to all Victorian Phase 1 trial centres.

VCCC STRATEGIC RESEARCH PLAN 2017-20 | 25

Increasing AYA Clinical Trial Access

The Program: Increase participation of adolescent and young adult (AYA) cancer patients in clinical trials, irrespective of whether a trial is open at an adult or paediatric hospital.

The key element of this program is implementing new administrative and governance processes that remove identified barriers to AYA clinical trial access.

Rationale AYA patients are enrolled into cancer clinical trials at a lower rate than adults or younger children, which may contribute to poorer outcomes for this group of patients. Many in this age group have rare cancers and typically, trials for these cancers are not open at multiple sites, creating barriers to participation. In addition, novel targeted therapy trials often cater only for adults or for children. Consequently 18-25 year olds may be unable to access clinical trials designed for paediatric patients at the Royal Children’s Hospital (RCH), while 15-17 year old cancer patients at RCH are unable to access clinical trials at adult hospitals.

Investment $340,000 Theme Focus

Activities include >> Conducting stakeholder meetings, mapping current processes and identifying opportunities for improvement. >> Identifying champions at each VCCC site, developing new processes required at each site and supporting communication between sites. >> Establishing new administrative, governance and other processes to support participation of AYA patients in a clinical trial while potentially having other parts of their treatment conducted at different sites. >> Developing and propagating guidelines and/or Standard Operating Procedures for referral of AYA patients to different sites. >> Validating that proposed new processes meet all regulatory requirements.

Key measures of success: >> number of AYA patients who have relevant clinical trials discussed with them in the clinic >> number of AYA patients referred between VCCC hospitals to assess enrolment in a trial

Goals

>> number of AYA patients recruited to a paediatric or adult cancer clinical trial.

>> Removal of barriers for adolescent and young adult cancer patients to access appropriate clinical trials.

>> number of investigators who report understanding of new clinical trial processes.

>> A greater number of AYA cancer patients participating in clinical trials which may offer them significant benefit.

26 | VCCC STRATEGIC RESEARCH PLAN 2017-20

This program will remove the barriers that can prevent adolescent and young adult cancer patients from accessing clinical trials that may benefit them.

Building Trial Group Capability

Investment $850,000 Theme Focus

The Program:

Activities include

Support the development of clinical trial activity in a broader range of clinical disciplines, thereby expanding the number of trials and increasing patient participation.

Providing tailored pathways for more clinical disciplines to build a clinical trial portfolio in their field, which includes:

The key elements of this program are: >> development of academic leadership for disciplines seeking to develop clinical trial activity >> creation of networks of clinicians and healthcare professionals across VCCC organisations >> training and mentoring for new clinical trial investigators within the network >> clinical trial fellowships >> access to the clinical trials resources and workforce development opportunities in other clinical trial programs within the SRP.

Rationale Expanding the diversity of clinical trials on offer will increase the chances that a patient will be eligible for an open trial. Clinicians from cancer related disciplines other than medical oncology and haematology have lacked opportunities to develop the expertise and experience needed to develop and run clinical trials.

Palliative care has been identified as the first clinical discipline to be supported in this program, as there is a large pool of patients across the alliance and the area has been highlighted as a priority by cancer patients and the community. The VCCC also has an existing leader with the academic credentials and research experience to build a trials program, and there is an opportunity to conduct both sponsored and investigator-initiated palliative care trials.

>> identifying and/or supporting clinician-researcher leaders to provide academic leadership and drive new clinical trials enterprise in their discipline >> support to build networks of clinicians and healthcare professionals that form the foundation for collaborative multi-site clinical trials >> professional development and mentoring of the workforce >> support to protect research time for a limited period until the trial group is self-sufficient >> evaluation to ensure lessons can be applied to subsequent trials groups.

Key measures of success: >> more palliative care clinical trials and more patients enrolled these trials >> number of palliative care healthcare professionals upskilled in clinical trials >> number of new or changed practice guidelines based on evidence from supported investigator-initiated trials >> changes in practice regionally, nationally and internationally that align with trial results.

Broadening and diversifying clinical trial groups expands patient access to clinical trials.

Goals >> A greater diversity of clinical trials on offer at any one time at VCCC sites. >> More clinical trials in palliative care initially, expanding to other disciplines such as supportive care, surgical oncology, allied health, radiation oncology and/or other groups when feasible. >> Establish clinical trials as routine practice within palliative care services.

VCCC STRATEGIC RESEARCH PLAN 2017-20 | 27

Clinical Trials: Building Capacity through Efficiency

The Program Generate new clinical trial capacity by improving efficiency, quality and consistency of clinical trial management to decrease costs per trial and free up site staff time for clinical trial work.

This program consists of a series of complementary projects that aim to increase capacity by reducing administrative, governance and regulatory workload for trials across the VCCC alliance.

Rationale Increasing the number of cancer clinical trials and clinical trial participation requires growth in trial infrastructure. Improving efficiency, quality and consistency of clinical trial management will decrease costs per trial and free up site staff time for clinical trial work by decreasing the administrative burden.

Many bottlenecks in clinical trial processes occur during start-up, such as timelines for governance and ethics approvals. Reducing the time taken to open clinical trials will increase the appeal of VCCC sites to commercial trial sponsors.

Investment $1.4m Theme Focus

Goals >> Increased efficiency, quality and consistency of opening and managing clinical trials at VCCC sites. >> Attraction of more commercially-sponsored trials. >> More clinical trials at VCCC partner sites.

Activities include >> Developing and implementing a series of complementary projects to increase efficiency of any trial within the VCCC. Initial steps will involve: ¬¬ bringing together key stakeholders, particularly clinical trial managers, to share experiences and identify opportunities for greater efficiency through collaboration; ¬¬ reaching consensus on and planning efficiency and/or harmonisation projects; ¬¬ commencing projects in priority order.

Key measures of success: >> number of prioritised efficiency and harmonisation projects generated and taken through to implementation.

Once prioritised projects have been agreed, measures of success will be developed for each project.

The VCCC investment in increasing efficiency, quality and consistency of opening and managing clinical trials will attract more sponsored trials and lead to more clinical trials available for cancer patients.

28 | VCCC STRATEGIC RESEARCH PLAN 2017-20

Investigator-initiated Trial Capacity Building

Investment $8.1m Theme Focus

The Program Provision of resources to help more investigators to open and conduct clinical trials, will significantly increase the number of VCCC investigator-initiated trials.

Activities include

The key elements of this program include:

>> mentoring of investigators including assistance with grant applications.

>> creation of a VCCC Clinical Trial Development Hub to support idea generation, protocol development, and mentoring of investigators >> development of a VCCC Clinical Trial Assistance Scheme to provide access to resources to support the development, conduct and management of selected investigator-initiated and non-commercial trials.

Rationale Increased support for investigator-initiated trials is the highest strategic priority for the VCCC alliance, aligning with recognition at a national level that this is the number one unmet need in the clinical trials sector. It is recognised that infrastructure to support non-commercial, ‘publicgood’ trials is not being addressed within current efforts to improve the conduct of clinical trials in Australia.

These trials benefit patients by asking questions that pharmaceutical or biotech industries are unlikely to invest in. On average, non-commercial trials at VCCC sites recruit more patients per trial than commercially-sponsored trials.

Cost-effective access to support for investigator-initiated trials will remove barriers to start trials and significantly increase the number of VCCC investigator-initiated trials.

Establishing VCCC Clinical Trial Development Hub offering: >> support for idea generation; >> support for protocol development including biostatistics;

Setting up VCCC Clinical Trial Assistance Scheme to: >> develop tenders and/or agreements with existing service providers to provide cost effective support for both contract research organisation (CRO)-like functions and trial management functions.

Key measures of success: >> number of investigator-initiated trials that attract grant, industry or philanthropic funding resulting from support from this program >> number of publications arising from supported investigator-initiated trials >> number of guidelines using findings from supported investigator-initiated trials >> changes in practice regionally, nationally and internationally that align with trial results.

This program to develop and open investigator-initiated clinical trials addresses the number one unmet need in the cancer clinical trials field.

Goals >> More high quality investigator-initiated clinical trials within the VCCC. >> Greater number of cancer patients enrolled in clinical trials. >> Improve quality and increase quantity of evidence for practice change. >> Expanded numbers of experienced clinical trial investigators. >> High quality, consistent start-up processes for investigator-initiated clinical trials. >> Consistent collection of data for non-commercial trials.

VCCC STRATEGIC RESEARCH PLAN 2017-20 | 29

Metrics for Clinical Trial Participation

The Program This program will develop metrics that not only measure system change, but can be used as evidence and levers for improvement of the clinical trial system, particularly to drive the system-wide cultural changes that will be required to achieve lasting outcomes.

The key elements of this program include: >> defining the value of clinical trials and developing metrics that reflect this

Investment $570,000 Theme Focus

Goals >> A suite of metrics agreed across the VCCC to allow improvements in participation, impact and innovation in clinical trials to be demonstrated.

Activities include >> Working closely with key stakeholders to gain consensus on the most useful, meaningful and practical metrics to measure trial numbers, participation, timeliness, cost-effectiveness, quality and impact.

>> testing and validating the feasibility of collecting agreed metrics that encapsulate the value of clinical trials, and address their potential to create perverse incentives.

>> Developing and testing agreed metrics within selected VCCC sites.

Rationale

Key measures of success:

While government, clinicians, researchers and cancer patients support improvement of the cancer clinical trials system, it is less clear how to achieve this or how to know when it has been achieved.

>> engagement of stakeholders as measured by attendance at relevant meetings and forums

Metrics have three roles in system change: measurement of change; as evidence for advocacy for changes in policy or process; and as levers to drive change. The key risk in developing metrics, particularly in terms of their use as a lever, is the creation of perverse incentives. In this scenario, the system improvement initiatives drift so that the focus is improvement of the metric rather than improvement of the system to achieve the original objectives. In contrast, wellconstructed, robust metrics can contribute towards positive system change when teamed with clear objectives that have buy-in from stakeholders.

Improvements in participation, impact and innovation in clinical trials cannot be demonstrated unless new metrics are developed and agreed.

30 | VCCC STRATEGIC RESEARCH PLAN 2017-20

>> Testing the feasibility and cost-effectiveness of data collection.

>> agreement on metrics to be tested and validated >> number of metrics agreed to be valuable to measure trial numbers, participation, timeliness, costeffectiveness, quality, impact and innovation >> number of metrics that are determined to be feasible and cost-effective to collect.

Once metrics are developed and agreed, they become a core part of how clinical trials are measured.

BUDGET BREAKDOWN Key Leadership and Collaboration D

Outstanding Cancer Workforce Research Cabability and Capacity Expand Clinical Trials R Q

S

C

B A

P O

E N

G M

H L

F J K I

A

B

C

D

E

Increasing AYA clinical trial access

Building trial group capability

Building capacity through efficiency

Investigatorinitiated trial capacity building

Metrics for clinical trial participation

$340,000

$850,000

$8,100,000

$570,000

F

G

H

I

J

Research and Education Lead Program

Building connectivity

Masters of Cancer Sciences

$620,000

$600,000

Develpment of workforce capacity and capability

Building nursing research capability

$1,800,000

$1,000,000

K

L

M

N

O

Building analytical capability for datadriven research

Precision prevention and tailored screening

Response and resistance to therapies

Immunotherapy

Precision Oncology

$1,300,000

$800,000

$940,000

P

Q

R

S

New approaches to clinical trials

Registry trials

Teletrials

$680,000

$1,800,000

Increasing awareness of clinical trials

$4,200,000

$1,400,000

$1,500,000

$1,100,000

$1,500,000

$900,000

VCCC STRATEGIC RESEARCH PLAN 2017-20 | 31

END NOTES

32 | VCCC STRATEGIC RESEARCH PLAN 2017-20

Notes

Governance

A detailed operational version of the Strategic Research Plan was submitted to the State Government of Victoria on 26 October, 2017.

The VCCC governance structure will provide oversight and support in the effective delivery of the outcomes articulated under this plan.

Principles The VCCC Strategic Research Plan was developed in line with the following Board principles: >> The draft Strategic Research Plan will align with (and interpret) the direction given in the Funding Agreement that the VCCC is a translational research platform. >> The SRP is to be based around four areas: building research capability; cancer education and training, translating research into practice and policy and developing the cancer clinical trials program. >> The programs proposed in the VCCC Strategic Research Plan should clearly build on the work already done within the VCCC partnership and on the research plans developed by the VCCC partners. >> The VCCC will not act as a funding body for research, but rather seek to build joint research capability and activities collaboratively with partners and by leveraging funding. >> The Strategic Research Plan will prioritise activities most likely to make the greatest impact on patient outcomes that cannot be easily achieved by individual VCCC partners alone.

The VCCC Governance Framework consists of a Board of Directors with appointments made to the Board by each of the Members of the VCCC Ltd. It meets every two months. The Board has an independent Chair and Deputy who are appointed by the State Government. The Board is served by a range of standing committees that provide expertise in, for example, areas such as cancer research, education and information management, and constitutes standing and project committees when required to meet operational needs.

The rules outlining the interaction and objects of the VCCC are contained in a joint venture agreement that appoints the VCCC Ltd to manage the operations and activity of the partnership.

During the Strategic Research Plan planning and implementation, the VCCC will review its governance structure to ensure it remains aligned with the role it plays, the manner in which it’s funded and the activities it’s delivering. A governance framework that can adapt to the changing needs of the organisation and best allows the partnership to achieve its objectives will be maintained.

A set of program development principles were also established to guide the development and prioritisation of programs.

VCCC STRATEGIC RESEARCH PLAN 2017-20 | 33

Acknowledgement and thanks The Board and Executive of the VCCC would like to thank the many contributors to this plan.

Particular thanks to Committee and Working Group Chairs: Professor Andrew Roberts, Chair of the Strategic Research Plan Working Group and the VCCC Cancer Research Advisory Committee; Professor Mark Rosenthal, Chair of the Clinical Trial Development Working Group; Professor Geoff McColl, Chair of the Cancer Education and Training Committee and Sophy Athan, Chair of the VCCC Cancer Consumers Advisory Committee (CCAC) as well as all members of CCAC for their significant contributions, counsel and advice.

Thanks to the members of the various committees and working groups who actively participated in the creation of this plan: >> Strategic Research Plan Working Group >> Clinical Trial Development Working Group >> Immunotherapy Working Group >> Outcomes Data Working Group >> Precision Oncology Working Group >> VCCC Cancer Research Advisory Committee >> Response & Resistance to Targeted Therapies Working Group >> VCCC Cancer Education and Training Advisory Committee >> VCCC Cancer Consumer Advisory Committee Thanks to all the other individuals who gave of their time, knowledge and expertise.

Finally, our thanks to the State Government of Victoria for sharing and supporting the vision of the VCCC and funding the development of this Strategic Research Plan.

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Victorian Comprehensive Cancer Centre Level 10, Victorian Comprehensive Cancer Centre 305 Grattan Street, Melbourne VIC 3000 Tel: 03 8559-7160 | www.viccompcancerctr.org Victorian Comprehensive Cancer Centre Ltd trading as Victorian Comprehensive Cancer Centre ABN 84 140 233 790 We acknowledge the Traditional Owners of the lands on which we work and pay our respects to their elders past and present.

36 | VCCC STRATEGIC RESEARCH PLAN 2017-20