The ACTA International Clinical Trials Conference 2019 brings together Australian and International experts in the cutting-edge design and conduct of clinical trials and registry custodianship, healthcare funding, policy and regulation, healthcare service delivery, health information technology, health economics and patient advocacy.

The Conference theme is Better Health Through Best Evidence, providing a platform for national and international stakeholders to share global advances in the development of self-improving healthcare systems.

The program’s topics include:

• Revolutions in clinical trials
• Data access and open access in trials
• Embedding clinical trials in routine practice
• Novel trials designs and conduct
• Maximising the value of clinical registries
• Interface with industry partners
• Improving public awareness
• The vital role of consumer involvement in clinical research

Speakers include Dr Richard Pazdur, Director of the US Food and Drug Administration Oncology Centre of Excellence and Prof Barbara Bierer, Professor of Medicine, Founder and Leader of the Multi-Regional Clinical Trials Centre of Brigham and Women’s Hospital and Harvard Medical School. Mr Simon Denegri, The National Director for Patients, Carers and the Public in Research at the National Institute of Health Research and Professor Neena Modi, Professor of Neonatal Medicine at Imperial College and Founder of the UK National Neonatal Research Database will also be members of ACTA’s stellar Conference line up.

To find out more go to: www.clinicaltrialsconference.com.au

Schedule

Thursday 3 October

Plenary 1

9:35 - A Clinician's View—Prof John Zalcberg OAM
9:45 - Why and how NHMRC supports clinical trials—Prof Anne Kelso AO
10:05 - MRFF perspective—Prof Ian Frazer AC FRS (slides not available)

Plenary 2

11:00 - Efficiency and quality by design—Dr Pamela Tenaerts
11:25 - Embedded adaptive clinical trials: A new standard?—Prof Derek C. Angus
11:30 - Evidence-based medicine for rare diseases – a new paradigm—Dr Richard Pazdur

Concurrent

Cockle Bay Room
13:30 - RCT approval process – international perspective—Dr Pamela Tenaerts
13:55 - ACSQHC clinical trials governance framework – implications for clinical trials in Australia—Dr Robert Herkes (slides not currently available)
14:20 - The strategy for implementation of the ACSQHC clinical trials governance framework—Dr Bernadette Aliprandi-Costa (slides not available)

C3.3 Room
13:30 - A USA perspective on diversity and inclusion—Prof Barbara Bierer
13:55 - Conducting clinical trials in partnership with Aboriginal and Torres Strait Islander communities—Prof David Peiris
14:20 - Clinical research trials achieving equitable health outcomes for Māori—Dr Matire Harwood

C3.4/5 Room
13:30 - How many times should a cluster crossover trial cross over?—Dr Jessica Kasza
13:48 - Modern approaches to handling missing data in clinical trials—Dr Tom Sullivan
14:06 - Aligning the design, conduct, and analysis of clinical trials using the estimand framework—Ms Sabine Braat
14:24 - Estimating treatment effects following adaptive clinical trials—Prof Ian Marschner

Plenary 3

C3.4/5 Room
15:30 - Trial-only item numbers for the MBS?—Prof Paul Glasziou (slides not currently available)
15:55 - Precision medicine and MSAC – the way forward—Prof Robyn Ward AM
16:20 - Value-based health care: A role for clinical trials—Mr Paul McBride (slides not currently available)

Friday 4 October

Plenary 4

09:35 - Industry and academia; Opportunities for greater partnerships—Dr Anna Lavelle (slides not available) 09:45 - MTP Connect – linking biomedical innovation to clinical trials in Australia—Dr Dan Grant (slides not available) 10:00 - New horizons for clinical trials and device registration—Dr John Skerritt (slides not available)

Concurrent

Cockle Bay Room
11:00 - What roles should consumers have and should any limits apply?—Simon Denegri OBE
11:20 - How to get started and where to look for consumer assistance?—Dr Belinda Kiely and Ms Leslie Gilham
11:35 - Lessons learned from the ANZMUSC experience—Ms Ornella Clavisi (slides not currently available)
11:54 - ACTA ‘Trial of the year Consumer Involvement Award’ winner from the TORPIDO 30/60 trial—Ms Melinda Cruz

C3.3 Room
11:00 - An ABC of embedded trials—Prof Neena Modi
11:18 - Registry-randomised trials: A practical model of embedding—Prof Chris Reid
11:36 - Waiver of consent for comparative effectiveness trials—Prof Meg Jardine
11:54 - Comparative effectiveness research: The SOCRATES proposal—Prof John Simes
12:12 - Should PROMs and PREMs be standard in clinical care and available for clinical trials?—Prof Christobel Saunders AO

C3.4/5 Room
11:00 - Patient and public perspectives in trials—Prof Tom Walley
11:25 - A framework for evaluating research priorities—A/Prof Rachael Morton (slides not currently available)
11:50 - Value of information analysis in prioritising research—Dr Haitham Tuffaha

Free Papers

Cockle Bay Room 1
13:30 - Conducting placebo controlled randomised trials of surgery in Australia—A/Prof Manuela Ferreira (slides not available)
13:45 - Recruiting for large scale clinical trials in Australian general practice—Prof Mark Nelson
14:00 - N-of-1 trials in clinical research: Opportunities and challenges—Dr Suzanne McDonald
14:15 - Linked data for randomised controlled trials: The George Institute for Global Health experience—Dr Carinna Hockham
14:30 - Can we prospectively estimate the economic returns of clinical trials?—Dr Haitham Tuffaha
14:45 - A new approach to the design of basket oncology trials in rare tumours—Prof Gillian Heller (slides not currently available)

Cockle Bay Room 2
13:30 - The IMPROVinG Evidence-based management and outcomes in communityAcquired Pneumonia (IMPROVE-GAP) trial—Ms Melanie Lloyd (slides not currently available)
13:45 - Protocol for ComeBACK: A pragmatic randomised controlled trial of physical activity coaching for adults with mobility limitations—Dr Leanne Hassett (slides not currently available)
14:00 - Lights, camera, action: Producing educational materials for adaptive trial designs—Ms Grace Currie (slides not currently available)
14:15 - The landscape of clinical trial activity on Indigenous health in Australia: A review using clinical trial registry data from 2008-2018—Dr Ge Xu (slides not currently available)
14:30 - Developing a New Zealand specific framework for research prioritisation in maternal and perinatal health—Clara Mossinger (slides not currently available)
14:45 - Process for waiver of consent in prehospital trials: The EXACT study as an example—Ms Natasha Dodge (slides not currently available)

C3.3 Room
13:30 - Bayesian adaptive trial design to accelerate discovery in regional anaesthesia—Dr Robert Gotmaker
13:45 - Recurrent time-to-event models with ordinal outcomes—Prof Val Gebski (slides not currently available)
14:00 - “Scientists rise up against statistical significance”[1] but type I error equal to 0.05 is what a regulatory body wanted from me—Ms Francesca Orsini (slides not currently available)
14:15 - Changes to aspects of ongoing randomised controlled trials with fixed designs—Dr Andrew Martin (slides not currently available)
14:30 - “Anchoring effect” in random effects meta analysis: A cautionary tale—Dr Gian Luca Di Tanna
14:45 - In cluster randomised trials with binary outcomes, plausible values of (i) the intracluster correlation coefficient and (ii) the standard deviation of true cluster prevalences are bounded by the overall prevalence, its complement, and one third—A/Prof Mark Chatfield

C3.4/5 Room
13:30 - The ORVAC trial protocol – a phase IV, double-blind, randomised, Bayesian adaptive, placebo controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian indigenous infants to improve protection against gastroenteritis—Dr Bianca Middleton
13:45 - A novel methodology for optimising endpoints for cystic fibrosis pulmonary exacerbation trials—A/Prof Tom Snelling (slides not currently available)
14:00 - The Molecular Screening and Therapeutics (MoST) program – A framework platform for multiple, parallel, signal-seeking phase II clinical trials of novel targeted therapies for patients with advanced cancer and unmet clinical need—Dr Lucille Sebastian Platinum (slides not currently available)
14:15 - C: A digital treatment registry for nesting clinical trials of strategies to manage hepatitis C in primary care—Ms Jessica Ramsay
14:30 - The Australasian Teletrial model – access to clinical trials closer to home using telehealth—Prof Sabe Sabesan (slides not currently available)
14:45 - Marketing and trial recruitment: an evaluation of promotional strategies from the T4DM diabetes prevention trial—Ms Karen Bracken (slides not currently available)

Plenary 5

15:45 - The UK Model of consumer engagement in clinical trials—Mr Simon Denegri OBE
16:10 - Consumer prioritisation using the James Lind Alliance method—Prof Jonathan C. Craig
16:35 - A consumer viewpoint of what consumer engagement means—Ms Anne McKenzie AM
17:00 - The consumer ACTA and CT:IQ involvement and engagement toolkit—Ms Anne McKenzie AM and Ms Tanya Symons

Saturday 5 October

Plenary 6

09:00 - A journal perspective—Dr Stuart Spencer (slides not available)
09:25 - The bigger picture; From open access to open scholarship—Prof Virginia Barbour
09:50 - An investigator perspective—Prof Barbara Bierer

Concurrent

Cockle Bay Room
13:30 - Management of linkage variables in clinical trials—Dr Felicity Flack
13:55 - Clinical quality registries and registry based trials – data protection issues—Prof John McNeil (slides not currently available)
14:20 - Harnessing digital technologies for clinical trial research—Dr Charmaine Tam

C3.3 Room
11:00 - How to design, conduct, and report trials optimised for value to end-users: The ACTA implementability guide—Prof Steve Webb
11:20 - Promoting impact and implementation: perspective of a funder—Prof Davina Ghersi (slides not available)
11:40 - Working together to promote implementability and impact: The AHRTC perspective—Prof Chris Levi
12:00 - What role can journals play?—Dr Stuart Spencer (slides not available)

C3.4/5 Room
11:00 - Trials in primary care – lessons from ASPREE—Prof Mark Nelson
11:20 - The REINVEST Study: Challenges in the community—Prof Peter Schofield (slides not currently available)
11:40 - Allied health clinical trials – experience from cerebral palsy—Prof Catherine Elliot
12:00 - NIHR models for primary care and mental health research—Prof Tom Walley CBE

Plenary 7

13:30 - Principles of embedding clinical trials in neonatal care—Prof Neena Modi
14:00 - The concept and challenges: An Australian perspective—Prof Nik Zeps
14:20 - Registry-randomised trials as a pathway to embedding—Prof Stephen McDonald (slides not currently available)