B17. Complex Clinical Trials. Design, participation, conduct and HREC review - Part II
Tracks
Clinical Research
| Thursday, June 13, 2024 |
| 2:45 PM - 3:45 PM |
| Pyrmont Theatre |
Chair & Speakers
Ms Leanne Weekes
Director Of Research, Policy and Advocacy
Bellberry Ltd
Chair: Complex Clinical Trials. Design, participation, conduct and HREC review - Part II
Abstract
The field of clinical trials is undergoing significant transformation with the growing popularity of complex trial designs, such as platform, master, adaptive, and n-of-1 protocols. In response to a standing-room-only exploration of both the opportunities as well as the challenges of Complex Clinical Trials at the 2023 ARCS Annual Conference, this follow-up session will examine where we are up to now from diverse sectoral viewpoints. This panel forum will delve into the design and ethical considerations linked to the adaptability of these trials in cancer trials, particularly regarding changes made after the trial's initiation and the integration of new sub-protocols. Perspectives from a HREC Chair, Governance office, Site and the Sponsor will illuminate the operational and ethical challenges in conducting these complex studies. This session will provide attendees with a deeper understanding of the intricacies of complex trial designs, the ethical and operational issues they entail, strategies for leveraging their benefits while addressing their risks. It promises to be an engaging and informative dialogue, offering valuable insights for professionals engaged in all aspects of clinical trial design and execution.
Biography
Leanne is the Director of Research, Policy, and Advocacy at Bellberry Limited.
Previously, Leanne was the Programme Director of CT:IQ, a national, MTPConnect-funded sector-wide, stakeholder-broad platform for continuous improvement in clinical research. Before CT:IQ, Leanne amassed 12 years of diverse experience in bio-pharma research and development, including 7 years managing clinical trials across Australia, New Zealand, the UK and Northern Europe for both Pharma and CROs.
Professor Michael James
Chair, Human Research Ethics Committee
Bellberry Limited
Complex Clinical Trials. Design, participation, conduct and HREC review - Part II
Biography
Michael James completed a PhD in Animal Physiology at the University of Adelaide in 1977 and has had a research career in the USA at The Jackson Lab, then Flinders Medical Centre, and finally in the Rheumatology Unit at the Royal Adelaide Hospital (RAH) where he was the Chief Medical Scientist and an adjunct Professor in the Dept of Medicine at the University of Adelaide. He is retired from both of those institutions.
He has been the Chair of a Human Research Ethics Committee (HREC) for 29 years; firstly at the Royal Adelaide Hospital for 14 years from 1995 to 2009 and then since 2009 as Chair of a Bellberry HREC.
Pamela Blaikie
Research Office Manager
St Vincent's Hospital Sydney
Complex Clinical Trials. Design, participation, conduct and HREC review - Part II
Biography
Pamela is the Research Office Manager at St. Vincent’s Hospital and has been in this role since January 2014. Prior to this she worked for UniQuest as Manager of Innovation and Commercial Development based at the University of Technology Sydney and for New York University as Business Venture Analyst where she was responsible for intellectual property management and technology commercialisation. Pamela has a Bachelor of Veterinary Science from the University of Queensland and a PhD in molecular genetics from New York University. She completed her postdoctoral fellowship at the Memorial Sloan Kettering Cancer Centre.
Dr Anna Swanson
Research Governance Manager
Chris O'Brien Lifehouse
Complex Clinical Trials. Design, participation, conduct and HREC review - Part II
Biography
Anna Swanson is the Research Governance Manager at Chris O’Brien Lifehouse, a not-for-profit public/private comprehensive cancer hospital in Camperdown, Sydney.
Anna has a PhD in Medical Microbiology and was a postdoc in the US and then the UK. She made the leap across the translational divide to patient facing clinical trials in 2016. Over a whirlwind few years, Anna has worked in regulatory affairs, as a study coordinator, and as part of a startup team before taking over as Research Governance Manager at Chris O’Brien Lifehouse in 2021. Last year, she was closely involved in the hospital’s first accreditation against the National Clinical Trials Governance Framework.
Research is one of the pillars of the Chris O’Brien Lifehouse Mission. The hospital has a busy research portfolio, from bench through to bedside, as well as one of the largest cancer clinical trials centres in Australia. The real life impact of research is seen there every day.
Ian Wu
Associate Director Study Start Up APAC
Beigene
Complex Clinical Trials. Design, participation, conduct and HREC review - Part II
Biography
Having been in the industry for the last 17 years, with experiences from monitoring to study management. I’ve found my passion in Study start up. Joining BeiGene in 2019, we’ve been working to provide better access through close collaboration with all stakeholders.
