Monday Lunch Livestream

01 May 2023

A holistic approach beyond adverse events in clinical trials

In published literature reporting on the evaluation of nonpharmacological interventions, it is apparent that researchers have either not thought about assessing risks and adverse effects, or not reported these robustly.

What are we missing, and how can we address these gaps? This talk uses examples to illustrate a proactive framework that can help interdisciplinary teams plan clinical trials for success – with a full understanding of benefits and potential harms, so interventions are ready for the real world of clinical practice and can be delivered safely.

Proactively thinking about adverse events and risks is critical to evaluating new interventions that can improve the lives of people living with cancer. However, existing frameworks for clinical trials don’t capture or assist in reporting the full range of risks associated with non-pharmacological interventions.

We need to be thinking about the mechanisms by which our intervention may be associated with risks and harms (and what is known about the frequency and severity of these) and how to report and record these events before and after they occur.

Using both an adverse event and risk assessment approach allows clinical trial protocols to be proactive about identifying and managing risk, and will improve the ability to use the intervention at scale.

The webinar will include a proposed framework for this purpose, followed by a panel discussion to explore the topic from clinician, research governance and consumer perspectives.

Presenters

Ms Belinda Fazekas
National Project Officer
IMPACCT Trials Coordination Centre (ITCC)

Belinda Fazekas oversees the implementation of clinical trial protocols including protocol and form design, data management, ethics submissions, and reporting. She is involved with site selection and training, and is responsible for the development of recruitment strategies, and standard operating procedures, data management and monitoring plans.
 

Dr Annmarie Hosie
Associate Professor, Palliative Care Nursing
The University of Notre Dame and St Vincent's Health Network Sydney

Dr Annmarie Hosie PhD is Associate Professor, Palliative Care Nursing at the University of Notre Dame Australia & St Vincent’s Health Network Sydney, and Adjunct Associate Professor at the University of Technology Sydney. Annmarie has led and contributed to several studies of delirium in palliative care, including of non-pharmacological and systems-level interventions.

Ms Celia Marston
Acting Manager, Occupational Therapy and Physiotherapy Department
Peter MacCallum Cancer Centre

Celia Marston is Acting Manager of the Occupational Therapy and Physiotherapy Department at Peter MacCallum Cancer Centre, Research Lead at Royal Melbourne Hospital and PhD Candidate at University of Technology Sydney. Celia has led and contributed to studies in allied health, rehabilitation and complex interventions in oncology and palliative care. This includes leading the CareNET trial at Peter MacCallum Cancer Centre – testing the feasibility of an intervention that aims to assist carers in hospital discharge.

Panel

Mr John Stubbs AM, Consumer

John Stubbs is a committed and passionate advocate for Australians affected by cancer and chronic disease. He is a regular speaker at medical conferences/webinars in Australia and internationally about health policy, advocacy, clinical trials, clinician training, research and the benefits of consumer involvement.

He was awarded an Honorary Associate of the University of Sydney - School of Medicine in 2009 for work in the promotion of Research and Clinical Trials in Australia and a Recognition Award from the Federal Department of Health in 2011 for “long-standing commitment to advancing the quality of radiation oncology services in this country”. John is currently on the board of Cancer Institute NSW and an active member of several committees, including MRRF, ACTA and NHMRC.

Dr Aaron Wong
Medical Oncologist
Peter MacCallum Cancer Centre and The Royal Melbourne Hospital

Dr Aaron Wong is a dual-trained Palliative Care Physician and Medical Oncologist and is Palliative Care Clinical Trials Lead at the Peter MacCallum Cancer Centre, and The Royal Melbourne Hospital.

Aaron has been Chief and Associate Investigator of several multi-centre Phase I – IV Palliative Care Clinical Trials which have involved various interventions including medications, devices and clinical activity.