Over recent years, concern has been expressed in relation to Australia’s competitiveness as a venue for commercially sponsored clinical research at the same time as the need for skills development and efficiency in clinical and health outcomes research is becoming urgent. In response, the Clinical Trials Action Group (CTAG) was established and charged with developing options to improve the Australian clinical trials operating environment.
Through the Translating Health Discovery into Clinical Applications consultation, several infrastructure deficiencies were noted, most notably in relation to early stage clinical trial capability. The early phase clinical trials industry employed over 300 people and earned more than $50 million in revenue, the majority of which is earned from international companies. Existing early phase units are operating at capacity, and a major factor limiting increased international export is bed capacity.
Other infrastructure deficiencies identified include a lack of consumer oriented internet resource and limited capacity for the implementation of personalised medicine due to biobanking and biomarker detection limitations.
To address current deficiencies in clinical trials infrastructure, funding from the Translating Health Discoveries into Clinical Application Super Science project will support the following initiatives:
- Development of Phase 1 infrastructure related to the Australian Advanced Treatment Centre involving the University of New South Wales and University of Sydney
- Enhancement of the Australian New Zealand Clinical Trials Registry
- Enhancement of the recently established paediatric clinical trials network through the adoption of and clinical trial data management system
- Enhancement of molecular pathology capacity in order to improve articulation of biomarker strategies into translational research programs and enhanced capacity in relation to biomarker identification and detection.
Hospital Based Clinical Trial Units
Development of Phase 1 infrastructure related to the Australian Advanced Treatment Centre (AATC) involving the University of New South Wales and University of Sydney. AATC will comprise two complementary developments:
- the demolition of an existing building on the Prince of Wales Hospital campus and construction of a four-storey building to house a 30-bed early phase clinical trials unit, ambulatory clinic space for later phase clinical trials, and research space that consolidates all researchers across the Prince of Wales Hospital campus the fit out of Level 14 of the Kolling building in the Royal North Shore Hospital campus as a 30-bed early phase clinical trials unit
- The funding allocated under this investment plan will be used to fit out and equip pharmacokinetic laboratories at the two locations, a critical need for investigator initiated Phase I trial activity. The investment will leverage considerable University and State Government funding accumulated for AATC.
Clinical Trial Registry
The Australian New Zealand Clinical Trials Registry will be enhanced, with a view to increased useability across multiple stakeholder groups. This enhancement will:
- Provide mechanisms to enable trial data submitted to ethics committees, regulators and other specialist registries to be automatically exported and displayed on ANZCTR
- Utilise the now available WHO International Clinical Trials Registry Platform web service so trials conducted in AUS/NZ but registered on other registries can be displayed and searched for on the ANZCTR.
- Enhance current advanced search functionality to better refine and display online user-initiated searches.
- To enable users (including consumers) to easily identify trials for which they are eligible
- Service a variety of consumer and clinical speciality groups who wish to display and search for ANZ clinical trials on their own websites by regularly exporting current ANZCTR data for their use.
Paediatric Clinical Trials Network
The recently established paediatric clinical trials network will be enhanced through the adoption of and clinical trial data management system. This infrastructure enhancement will:
- Enhance coordination of multi-site clinical trials, supporting randomisation, direct data capture at multiple sites and allowing rapid and accurate central analysis of data.
- Reduce times for site feasibility analyses and allow unprecedented efficiencies in the targeted recruitment for paediatric trials.
- Significantly build translation research capacity, enable collaboration and would leverage existing operational investments made by individual sites participating in paediatric clinical trials.
In several key areas of translational research, future developments will increasingly focus on targeted therapy requiring increasingly sophisticated technology platforms. For example, in cancer, there is currently a proliferation of highly effective, targeted drugs active against specific genetic subtypes of cancer. However, there is scope for dramatic improvements in the use of existing treatment protocols based on increasing interrogation of individual patient characteristics. Underpinning both approaches is a need for enhanced molecular pathology capability operating under appropriate quality control systems and systematic improvements to biobanking services.
The THD Super Science funding will enhance Australia’s molecular pathology capacity in order to improve articulation of biomarker strategies into translational research programs and enhanced capacity in relation to biomarker identification and detection. This enhanced capability will improve recruitment into patients into clinical trials necessitating biomarker assessment using new technologies.
Molecular pathology is essentially a new discipline that involves the performance of biological tests (most frequently DNA-based) to aid in the initial diagnosis of diseases such as cancer, the identification of genetic-risk factors that predispose individuals to developing the disease, the prediction of clinical outcomes, the monitoring of disease progression and to guide the selection of the most appropriate therapies. Accordingly, diseases are increasingly being defined by their molecular characteristics rather than their histological appearance. Recent widely discussed examples in breast and lung cancer highlight the importance of this new treatment paradigm.
The reliance on molecular pathology testing capability underpins the future of “Personalised Medicine”, a new disease management paradigm where treatment decisions are increasingly informed by biological characteristics. While tailoring therapy to patient characteristics is standard medical practice, the capacity to interrogate such characteristics has been increased dramatically through technological advances.
Funding will be used to increase capability with respect to molecular pathology at key centres across Australia including the development of a national reference laboratory for cancer-related molecular pathology. The development will be able to provide an unparalleled opportunity to establish a world-class cancer molecular pathology facility to accelerate the translation of research discoveries and new treatments into improved clinical care. The national reference laboratory will develop high complexity cancer genetics and molecular pathology tests for Australian cancer patients and help establish state-based programs so local solutions can then be adopted. It will provide a test development program with a seamless transition to clinical diagnostics. Importantly it will therefore house a suite of translational research laboratories specifically designed for the development of clinical diagnostics, and will establish partnerships with biotechnology and diagnostic companies and provide specialist training in cancer genetics and molecular pathology to enhance Australia’s pathologist and medical laboratory scientist workforce. In doing so, will increase Australia’s competitiveness in participating in molecularly based clinical trials that are increasingly using molecular pathology to enrich for patients with the appropriate target.
Additional funding for molecular pathology capability will also be provided to other leading centres with the potential to increase activity in this discipline. Funding will be allocated to the acquisition of infrastructure enabling increased participation in cutting edge clinical research involving biomarker assessment and will leverage other significant research programs.
Pharmacogenomic Research for Individualised Medicine
The Garvan Institute investment will leverage recent Cancer Council NSW investment in a collaborative multi-institutional and multi-disciplinary program in pharmacogenomics across NSW called PRIMe (Pharmacogenomic Research for Individualised Medicine) that can deliver outcomes through consolidation of expertise in personalised medicine research across the spectrum of discovery through to clinical implementation. This research program encompasses the cornerstones of personalised medicine including: tumour pharmacogenomics, pharmacokinetics and pharmacodynamics; and provides a unique opportunity to integrate capacity and infrastructure that is complementary to reach a critical mass in NSW necessary for making significant advances in this area. The inaugural PRIMe Institutions were Garvan Institute of Medical Research, Sydney Cancer Centre, Hunter Medical Research Institute, Westmead Cancer Centre / Millennium Institute, University of Sydney, Children’s Hospital Westmead and St. George Hospital. The THD Super Science investment is also a critical leveraging factor underpinning the success of a $3.75 million Translational Cancer program grant to Garvan from the Cancer Institute of NSW which will commence in 2011.