National Neuroscience Facility

PlatformsNeuroscience Trials Australia

(Formerly Clinical Neurosciences)

Introduction

Neuroscience Trials Australia (NTA) was established in 2001 as the clinical trials platform of the National Neuroscience Facility (NNF), building on the established goodwill and cooperation between Australian investigators to develop a clinical trials network across the nation. The general aims are to raise the profile of Australian clinical trial capabilities, secure a larger share of the international clinical trials market, and provide a range of services to the benefit of both industry and researchers for sponsored clinical trials and local investigator driven studies, respectively. NTA was established to coordinate the emerging disease specific clinical trial interests groups in the neurosciences, to provide support and services to formalise those networks and to facilitate interactions with biotechnology and pharmaceutical sponsors of clinical research. Not just enhancing the capabilities of the existing trials networks, NTA has provided the impetus to establish, support, and promote additional networks across disease specific interests groups within the neurosciences, and has interacted with similar organisations in other therapeutic areas. The overall effect has been to achieve the first phase of the process towards significantly enhancing our national clinical trial capabilities in this therapeutic domain and to ideally place the organisation to play a key role in the translation of novel and effective treatments and therapies into clinical practice with resultant benefits in the health of all Australians. Ultimately, the facilitation and expansion of investigator-driven and Australian-led neuroscience trials of international importance will be the benchmark of success for the network.

Aims and Objectives

The primary aim of this platform is to build in Australia a world-class infrastructure for neuroscience clinical trials with a unique funding model to ensure its sustainability for future generations. The objective is to bring together, support and promote neuroscience clinical investigators and to facilitate interactions with the biotechnology and pharmaceutical industries both nationally and internationally, and in doing so to assist in the translation of quality research into clinical practice and, ultimately, better health outcomes for the Australian public.

NTA; a unique service from concept to commercialisation as the clinical trials platform of the NNF

Australian investigators have a strong track record for quality and timeliness in clinical trials, particularly Phase III, across a range of therapeutic areas including the neurosciences. However, large multinational pharmaceutical companies have traditionally overlooked Australia when selecting sites for innovative early Phase trials and to a lesser extent larger multicentre Phase III trials.

The Australian clinical trials environment enjoys a number of competitive advantages:

Facilities and Expertise

	Internationally high standards of clinical medicine
	Clinical homogeneity of these standards
	A stable political base
	Cohesive and mutually supportive professional networks of investigators with a common interest
	Relatively stable patient population facilitating patient contact and trial follow-up
	Lower cost than USA and many European countries

The key element in the development of the NTA has been the formalisation of involvement by the various neuroscience disease interest groups and trial sub-networks as members of the platform under the national imprimatur of the National Neuroscience Facility. The ongoing support of the sub-networks and investigator interest groups is a central plank in NTA's ability to represent neuroscience investigators across the nation. As a part of the NNF, NTA is able to access the services and expertise made available through the other NNF platforms. The sum of these capabilities is a one-stop-shop from drug discovery through basic and preclinical science to clinical trial evaluation

NTA Structure Our core business is to facilitate neuroscience clinical trials for investigators and sponsors. Our collaborative structure provides us with the ability to add value via a range of clinical services, and the ability to access target patient populations using state of the art facilities across multiple centres. NTA is lead by two co-platform leaders, Professors Geoff Donnan and Stephen Davis, and managed by a small administrative team based at the coordinating centres, the NSRI and Department of Neurology Melbourne Health. Governance is provided by a Platform Management Board made up of representatives of the nine disease groups and a leading neuropharmacologist, Professor Frank Vajda from the Australian Centre for Clinical Neuropharmacology (St Vincent's Health Victoria). A Scientific Advisory Committee will be established in the coming year and will be charged with independently evaluating research proposals and overseeing the distribution of seed funding to support and encourage innovative investigator-driven Australian research in the neurosciences.

Group	Clinical Trials Network	Representative	Alternate
The Dementias	Australian Consortium of Centres for Clinical Cognitive Research (AC4R)	Dr Karyn Boundy (Queen Elizabeth Hospital SA)	A/Prof Michael Woodward (Austin Health VIC)
Epilepsy	Epilepsy Society of Australia	Prof Sam Berkovic (Epilepsy Research Centre VIC)	Dr Nicholas Lawn ( Royal Perth Hospital WA )
Migraine		A/Prof Alessandro Zagami (Institute of Neurological Sciences NSW)	Dr Richard Stark (Alfred Hospital VIC)
Movement Disorders	Movement Disorders Society Clinical Research & Trials Group	Dr Andrew Hughes ( Austin Hospital VIC)	Dr Richard Stell ( Sir Charles Gairdner Hospital WA )
Multiple Sclerosis	Australian Multiple Sclerosis Clinical Trial Network	To be confirmed
Neuromuscular Diseases		Prof Frank Mastaglia (Australian Neuromuscular Research Institute WA)
Neurosurgery	Neurosurgical Society of Australasia	Prof Peter Reilly Royal Adelaide Hospital (SA)	Mr Glenn McCulloch (SA)
Pain	Faculty of Pain Medicine (Aust and NZ College of Anaesthetists )	Prof Robert Helme (Western Hospital VIC)
Stroke	Australasian Stroke Trials Network (ASTN)	Dr Mark Parsons (John Hunter Hospital NSW)	Dr Denis Crimmins (Gosford Hospital NSW)

	Services Neuroscience Trials Australia was established to enhance the national health and medical research effort in Australia by directly supporting investigators and clinical trialists. This is being achieved by providing a range of clinical trial services particularly for investigator-initiated studies, and acting as an interface between investigators and industry. NTA's administrative team provides an effective interface between industry and investigators, adding value through the collective promotion of Australian investigators and the effective linking of sponsors with suitable clinical sites, and supporting investigators with clinical trial administrative services. It has been recognised that there are significant benefits to all involved of an independent network to facilitate and attract industry sponsored trials to Australia and to provide resources to support investigator driven studies.
Services to Investigators

	Statistical consulting and support
	Access to new commercial trial opportunities
	Regulatory and Ethical submission advice
	Trial design, feasibility and budgeting
	Data management
	Professional and coordinated liaison with industry concerning budgeting and trial management
	Expert review of scientific quality, merit and feasibility of proposed trials

Services to Industry

	Advice concerning scientific merit, quality and feasibility of trials (particularly relevant for early phase trials)
	Detailed and transparent study budgets, and coordinating payments across sites
	Streamlining clinical trials processes, e.g., mutual acceptance of ethical approvals
	Advice on web based integrated trial management solutions that track clinical trial approvals and patient accruals
	One stop shop collaborative site selection
	Collaborative resources to attract new trial activities to Australia
	Advocacy on HREC, insurance and regulatory issues

NTA adds value to the clinical trial process by providing clinical and regulatory services from protocol review, site selection, HREC submission and documentation, data management, to statistical and clinical trial design support. As the clinical platform of the NNF, the NTA provides the clinical trial link in the drug discovery value chain and is ideally placed to advocate on the behalf of investigators and researchers for common HREC recognition, budget benchmarking, on insurance matters and collectively promote Australian clinical trial capabilities. Despite the competition between individual investigators for clinical trials it is recognised that there are benefits afforded by an independent network to facilitate and attract industry-sponsored trials to Australia and to provide resources to support investigator driven studies.

Access

The Management Board ensures fair and equitable access to the platform's resources by including representatives from across the range of disease specific interests groups in the neurosciences. Access to the NTA services will be via the networks, each with their own membership rules and regulations, with the distribution of trials based on the capabilities of each site, in particular the ability to recruit patients as required under the trial protocol and within the negotiated trial budget.

Research Fund

As the nexus between the aims and objectives of the platform and the business model has been refined, it has become clearer that one of the significant opportunities and probable drivers of success of the NTA is to establish a research fund to support investigator driven studies. The business model includes a small administrative levy on all industry-sponsored trials negotiated by NTA which is then entirely directed towards a research fund open to all neuroscience investigators in Australia to support investigator driven studies.

Contact

Dr Peter Keller
Neuroscience Trials Australia
Level 2 Neurosciences Building
300 Waterdale Road
Heidelberg Heights 3081
Tel: + 61 (0)3 9496 4482
Fax: +61 (0)3 9496 2650
Email: pkeller@neurotrialsaustralia.com

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