discover

innovate

collaborate

STRATEGIC PLAN 2017 - 2021

Better healthcare through research Vision & Direction Better healthcare through research

NHMRC Clinical trials Centre (CTC) Key focus areas for 2017 – 2021 EXCELLENCE INNOVATION EVIDENCE aims to be a leading academic Academic clinical trials research Better health practice through Use best evidence to inform best research organisation excellence innovative clinical trials practice in Australia and among the most sought after collaborators in the world. We will: Lead quality Develop new trial methods in Integrate trial evidence for better in theme areas (cancer, CVD, design, biostatistics, risk modelling decision making, guidelines, diabetes, obesity and neonatal) and health economics implementation, policy Mission Our goals are to: -- to bring together world-class -- to extend our methodological -- to combine findings from To embed quality clinical trial expertise in trial methods and work in adaptive trial multiple trials in systematic conduct, clinical disciplines, designs, patient preference reviews and to undertake research into health care biostatistics, health economics, assessment, prognostication, health economic analyses biochemical and molecular diagnostic test evaluation and to provide robust evidence sciences cost-effectiveness analysis in for health care decisions for practical application personalised care, guidelines -- build international and policy formulation collaborations Purpose -- embed translational studies -- deliver quality education, The NHMRC CTC will be recognised as a leader training, teaching and development programs of clinical trials research excellence, the innovator for the conduct of investigator-initiated clinical trials By concentrating on: -- research of key questions in -- identifying optimal treatment -- bridging the evidence-practice cancer, CVD, diabetes, obesity strategies for individual gap and the principal driver for translating clinical trials and perinatal diseases patients and for populations at risk -- developing on-line risk evidence into practice. Our approach is to apply -- relationship building with assessment tools for collaborative trials groups -- incorporating genomics, personalised treatment choice; our inherent strengths, breadth of knowledge and Academic Research molecular biology and new Organisaitons (ARO) to therapeutics linked to clinical -- enhancing unbiased systematic and expertise, engage and lead our network of undertake large-scale and/or molecular profiles in reviews, international trials theme areas communities and national and -- undertaking meta-analysis to -- integrate basic translational -- embed health economic further global collaborative international collaborators to advance clinical sciences through the use of evaluation into trial design initiatives. trial-related biospecimens, for trials research. biomarker discovery -- development of efficient, novel, -- incorporating new findings and adaptive trial designs. into systematic reviews and evidence-based guidelines -- platform trials built on trial registries and globally -- working with policy makers CORE VALUES: accessible web-based studies and politicians

We value integrity, professionalism and collaboration -- Increasing the value of clinical trials to the public Better healthcare through research Excellence

Academic clinical trials research excellence

Through a strong organisational culture and the dedication of focussed staff, we can continue to Strategic objective 1: improve the quality of our research. We will focus on developing new opportunities for the engagement, retention and development of our staff and provide to bring together world-class innovative infrastructure that will support and facilitate the effectiveness and sustainability of our expertise in trial methods and dynamic and productive workplace. We will continue to recognise outstanding effort and leadership that conduct, clinical disciplines, contributes to the quality of our research endeavours. biostatistics, health economics, Four interrelated strategic objectives will help us to achieve our research goal of leading quality clinical biochemical and molecular research in theme areas (cancer, CVD, diabetes, obesity and neonatal). sciences In this 2017–2021 strategy, we have outline three interrelated strategic areas that will help us to achieve our goal of Initiative - research of key questions in cancer, CVD, diabetes, obesity and perinatal diseases becoming the leading academic clinical trial research organisation in Australia and among the most sought after Cancer – We will aim to extend our collaborative clinical trials research program and undertake more collaborators in the world. The key focus areas are within the molecular profile based and immune checkpoint inhibitor clinical trials. Focus will be directed to three themes that underpin our strategic plan : Excellence (in leading large-scale international trials which define best practice for large patient populations by research and education), Innovation and Evidence. assessing the impact of interventions on survival and quality of life.

Cardio vascular, diabetes, obesity – We will design and conduct innovative studies to identify novel therapeutic strategies and change practice in large populations

Perinatal – We will extend our collaborative trials research program, drive new standards of care in perinatal disease globally and assess economic value of treatments in the field Better healthcare through research Excellence Innovation

Strategic objective 2: Strategic objective 3: Better health practice through innovative clinical trials build national and embed translational studies Our goal is to develop new trial methods in design, Strategic objective 5: international collaborations into our trials biostatistics, risk modelling and health economics to extend our methodological Initiative - relationship building with collaborative Initiative - integrate basic translational sciences work in adaptive trial trials groups and Academic Research Organisations through the use of trial-related biospecimens, for (ARO) – nationally and internationally biomarker discovery designs, patient preference assessment, prognostication, We have a long tradition in establishing collaborations New health technologies and new treatments, in diagnostic test evaluation and that enable us to participate in, and lead, particular, genomics, molecular biology and new international clinical trials. We are committed to therapeutics linked to clinical and/or molecular cost-effectiveness analysis in working closely with our established collaborative profiles, have opened to more personalised medicine, partners to develop new concepts in clinical trials where the target trial populations are becoming practical application that answer questions important to the population, smaller. This has increased the potential for greater government and industry. Our focus will be on benefit from personalised care. Well-designed clinical pursuing funding from non-traditional sources to trials integrated with translational research are critical Initiatives include - support the conduct of large-scale clinical trials, raise to real advances in patient care. • identifying optimal treatment strategies for the profile of innovative trial design and incorporate individual patients and for populations at risk new technologies. • incorporating genomics, molecular biology and new therapeutics linked to clinical and/or Through investing in international alliances we have molecular profiles in theme areas attracted like-minded researchers and developed an • embedding health economic evaluation into trial enviable reputation for quality clinical trial design design and conduct. The reputation of our researchers and Strategic objective 4: • developing efficient, novel, and adaptive trial collaborative partners also attracts interest from designs. pharmaceutical companies, governments, health • conducting platform trials built on trial registries services and research organisations, looking for deliver quality education, and globally accessible web-based studies opportunities to support or undertake clinical research on a global scale. training, teaching and A focus for our next stage of strategic growth is development programs We will build on our successful research methods to to extend our collaborative networks and work improve trial design, undertake complex analyses and with consortia whose purpose best aligns with our better synthesise trial evidence to change practice academic and multidisciplinary agenda. Funding from Due to our expertise in the design, conduct and and policy. We aim to further develop expertise and traditional and non-traditional sources will enable interpretation of clinical trials we are uniquely placed leadership in a program of platform trials to allow us to leverage the expertise and collegiality of to provide support and advice to clinical researchers. simultaneous evaluation of multiple biomarkers and extensive established national and international trial We will continue to develop and deliver a program therapies with those showing promise graduating networks and global collaborative hubs to promote of education, training and teaching programs that to larger enriched controlled studies. Research into the development and execution of priority-guided, are aimed at increasing and improving the extent, patient preference, adherence-adjusted estimates of peer-reviewed, investigator- and consumer-driven, quality, interpretation, implementation and advocacy treatment effect, linkage of diagnostic test evaluation international trials. of clinical trials research in Australia. and treatment trial information, and economic modelling methods will allow us to assess national impacts of potential health policy decisions.

Our research strategy will tackle problems in this new environment by bringing together world- class expertise in trial methods, clinical disciplines, biostatistics, health economics, biochemical and molecular sciences, and international collaboration to ensure the most important translational studies are embedded in the program. Better healthcare through research Better healthcare through research Evidence

Best evidence informing best practice Measuring success

Our goal is to integrate trial evidence for better Measure of research and education excellence decision making, guidelines, implementation, policy Strategic objective 6:

to combine findings from Strategic Objective Initiative Key indicators multiple trials in systematic 1 to bring together world-class research of key questions in Cat 1-4 research income; expertise in trial methods and cancer, CVD, diabetes, obesity publications reviews and to undertake conduct, clinical disciplines, and perinatal diseases biostatistics, health economics, health economic analyses biochemical and molecular to provide robust evidence sciences 2 build international relationship building with New partnerships, for health care decisions for collaborations collaborative trials groups Collaborative agreements and Academic Research personalised care, guidelines Organisations (ARO) – nationally and internationally

Initiatives include - 3 embed translational studies integrate basic translational Translational studies undertaken • bridging the evidence-practice gap sciences through the use of • developing on-line risk assessment tools for trial-related biospecimens, for personalised treatment choice; biomarker discovery • enhancing unbiased systematic reviews, • undertaking meta-analysis to further global 4 education, training, teaching Student numbers, professional collaborative initiatives. and development programs development undertaken by • incorporating new findings into systematic reviews staff and evidence-based guidelines • working with policy makers and politicians • increasing the value of clinical trials to the public Measure of new trial methods in design, biostatistics, risk modelling and health economics

A major health care challenge is translating the Strategic Objective Initiatives Key indicators research findings generated from clinical trials into clinical practice, disease prevention and strategies 5 to extend our methodological • identifying optimal Number of new and innovative to improve population health. Build on our previous work in adaptive trial treatment strategies for trials commenced work we will continue to incorporate new findings into designs, patient preference individual patients and for systematic reviews and evidence-based guidelines assessment, prognostication, populations at risk and evaluate the effectiveness, cost-effectiveness diagnostic test evaluation and • incorporating genomics, and implementation of successful clinical trials cost-effectiveness analysis in molecular biology and interventions in primary care and community settings. practical application new therapeutics linked to We will develop innovative ways of combining trial clinical and/or molecular evidence and integrating trial evidence with individual profiles in theme areas patient profiles of risk and preference to aid decision • embed health economic making, including methods for linkage of genetic evaluation into trial design and biomarker information to patient outcomes in • development of efficient, defining patient risk and treatment benefit. We will novel, and adaptive trial also embed economics into clinical trials and develop designs. guidelines to improve decision-making in health policy • platform trials built on trial and practice. registries and globally accessible web-based studies

Better healthcare through research Measure of the integration of trial evidence for better decision making, guidelines, implementation, policy

Strategic Objective Initiatives Key indicators

6 to combine findings from • bridging the evidence- Publications, reports multiple trials in systematic practice gap reviews and to undertake • developing on-line risk health economic analyses assessment tools for to provide robust evidence personalised treatment for health care decisions for choice; personalised care, guidelines • enhancing unbiased and policy formulation systematic reviews, • undertaking meta- analysis to further global collaborative initiatives. • incorporating new findings into systematic reviews and evidence-based guidelines • working with policy makers and politicians • increasing the value of clinical trials to the public

“The University of Sydney will be recognised as a world leader in health and medical research and will deliver outcomes of significant benefit for the health and wellbeing of society.”

(Wills Review)

Better healthcare through research