A national summit of investigator-initiated clinical trials networks.
28-29 March, 2014
Melbourne

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More than 165 senior representatives from 95 organisations involved in clinical trials attended ACTA’s inaugural national summit. Presentations, panel discussions and a workshop-style business meeting formed the 1.5 day meeting.

SUMMIT OBJECTIVES

• Bring senior representatives from Australia’s national and state-based clinical trials networks, clinical trial coordinating centres and clinical quality registries across all of the major disciplines and disease groups together to connect with one another and with key health policymakers and opinions leaders.
• Discuss innovative opportunities for increasing the impact of investigator-initiated clinical trials and the capacity of collaborative networks to answer important clinical questions and provide better evidence to support the delivery of high-quality health care.
• Consider the achievements of existing clinical trials networks in Australia that have made major advances in improving patient outcomes and the cost-effectiveness of treatments, and explore ways to leverage the expertise that has been gained to support new and developing networks.
• Provide an opportunity for the investigator-initiated clinical trials community to have direct input into the development of the Australian Clinical Trials Alliance, its strategic goals and priorities for supporting the sector

​KEY OPPORTUNITIES AND STRATEGIES FOR GENERATING BETTER EVIDENCE TO SUPPORT HIGH QUALITY HEALTHCARE

A range of opportunities and key strategies to increase the capacity of clinicians working within the Australia health system to generate better evidence to support the delivery of high-quality healthcare were presented at the Summit.
Those raised most commonly included:

• advocating for the health and economic benefits of clinical trials and clinical quality registries to support a self-improving health system;
• conducting innovative clinical trials that address the healthcare system’s most important clinical questions;
• coordinating and sharing resources and expertise between networks (eg. outcome measurements, Data Safety Monitoring Boards)
• linking networks to conduct more cross-discipline trials
• advancing local expertise in trial methodology to meet the modern challenges of recruitment in smaller sub-populations of patients or where smaller effect sizes in commonly use interventions have the greatest potential for benefit;
• standardising common documentation, such as patient information sheets and case-report forms;
• abolishing the need to gain approval from multiple ethics and governance committees to conduct multicentre trials;
• moving to a regulatory framework that is proportionate to the additional risk for participants participating in public-good clinical trials;
• developing a model for ‘opt-out consent’ for comparative efficacy studies when these involve widely used and approved therapies;
• liaising with the Independent Hospital Pricing Authority to develop appropriate costing frameworks for investigator-initiated clinical trials;
• improving the quality of routinely collected data and facilitating linkage to research databases;
• expanding clinical registries to collect risk-adjusted outcomes data across a broad range of high-cost high-significance areas of medicine;
• incorporating trials within clinical quality registries;
• working more closely with government, regulators and policymakers - particularly during the trial planning and development phases;
• identifying opportunities to partner with industry to both conduct trials and improve the competitive environment for conducting trials in Australia;
• making research outputs a key performance indicator for hospitals;
• increasing public support through a major public education campaign to inform the community of the purpose and importance of clinical trials;
• developing impactful models of consumer engagement in clinical trials;
• securing sustainable infrastructure funding for networks to replace wasteful ‘project by project’ funding;
• securing sustainable funding for methods centres (with strong epidemiology, biostatistics and data-management capabilities) that can support multiple trials networks and registries; and
• performing ‘research on research’ to demonstrate and understand what it is we currently do, how it can be done better and how it impacts healthcare outcomes.

Based on these proposals, ACTA can provide substantial leadership in the following broad areas:
 

• advocacy and engagement
• communication, coordination and networking
• education and knowledge exchange
• policy recommendations
• funding and regulatory reform
• public education
• ‘research on research’

Organising Committee

Professor Steve Webb (Convenor), Immediate Past Chair, ANZICS Clinical Trials Group
Professor Andrew Davidson, Chair, Paediatric Trials Network Australia
Professor Tony Keech, Deputy Director, NHMRC Clinical Trials Centre
Ms Imelda Lynch, Director, Bellberry Limited
Dr Gordon McGurk, Director, Research Policy Taskforce, NHMRC
Dr Clive Morris, Head, Strategic Policy Group, NHMRC
Professor John Simes, Director, NHMRC Clinical Trials Centre
Ms Rhiannon Tate, Executive Officer, ACTA
Professor John Zalcberg OAM, Chair, Australasian Gastro-intestinal Trials Group
Adj. Assoc. Professor Nik Zeps, Group Research Coordinator, St John of God Healthcare

Invited Speakers

Prof Warwick Anderson AM, CEO, NHMRC
Prof Rinaldo Bellomo, Director, Intensive Care Research, Austin Health
Mr Adrian Bootes, CEO, ARCS
Prof Alan Cass, Director, Menzies School of Health Research, Darwin
Prof Andrew Davidson, Chair, Paediatric Trials Network Australia
Prof Davina Ghersi, Senior Principle Research Scientist, NHMRC
Ms Imelda Lynch, Director, Bellberry Limited
Prof John McNeil AM, Head, School of Public Health & Preventative Medicine, Monash
Dr Clive Morris, Head, Strategic Policy Group, NHMRC
Dr Dorota Pawlak, Head, Research Development, JDRF
Prof Vlado Perkovic, Executive Director, The George Institute for Global Health
Prof Deborah Schofield, Chair of Health Economics, NHMRC Clinical Trials Centre & School of Public Health, University of Sydney.
Dr Brendan Shaw, CEO, Medicines Australia
Dr Joanne Shaw, Research Manager, Psycho-Oncology Co-operative Research Group
Prof John Simes, Director, NHMRC Clinical Trials Centre
Prof John Skerritt, National Manager, Therapeutic Goods Administration
Ms Kylie Sproston, CEO, Bellberry Limited
Prof Steve Webb, Immediate Past-Chair, Australian & New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG)
Prof John Zalcberg OAM, Chair, Australasian Gastro-Intestinal Trials Group (AGITG)
​Adj/A/Prof Nik Zeps, Group Research Coordinator, St John of God Healthcare

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The ACTA Summit 2014 was officially supported by the National Health and Medical Research Council.
 

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ACTA gratefully acknowledges the support of Summit Major Sponsor, Bellberry Limited.