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Registry-based trials

SPHPM is not only leading the world in expertise in the establishment and maintenance of clinical quality registries and clinical trials, but is at the forefront of the design and delivery of registry-based trials.

This ‘newer’ trial type leverages the methodological rigour of clinical trials with the infrastructure of clinical registries as a platform for recruitment, randomisation, data collection, randomisation, and/or follow-up.

In doing so it is intended that these trials reduce the challenges associated with traditional clinical trials through enhanced generalisability of findings, rapid enrolment, completeness of follow-up, all at lower cost.

SPHPM has been at the forefront of the design and delivery of 13 registry-based trials.

DIAAMOND: Diagnosis of aplastic anaemia, management, and outcomes utilising a national dataset

A national registry-based clinical trial using a novel adaptive (Bayesian) study design, to investigate the benefit and costs of avatrombopag, a second-generation thrombopoietin receptor agonist, in addition to conventional immunosuppressive therapies, in aplastic anaemia (a rare disease).

Registry: Aplastic Anaemia and other bone marrow failure syndromes Registry (AAR)

Use of registry for: Recruitment, baseline data, outcome data (including long-term outcome data), comparator data

Why is registry involvement important for this trial?

Enables results to be rapidly available for translation into policy and practice
Enables long-term follow up following use of a novel agent (avatrombopag) in a rare disease
Expands Australian rare diseases research capacity in clinical trials and registries
Provides comparator group for a rare disease where randomised trials are not feasible

Changes to the registry to enable the trial:

Additional registry fields included

Partnerships:

Involves an established national network of sites and clinicians interested in aplastic anaemia and excellent links with the Australasian Leukaemia & Lymphoma Group, Maddie Riewoldt's Vision, the Australian Bone Marrow Donor Registry, the Worldwide Network for Blood & Marrow Transplantation, the Haematology Society of Australia & New Zealand, the World Health Organization, the International Society of Blood Transfusion, and the Australian & New Zealand Society of Blood Transfusion.

ECMO-Rehab - A randomised controlled trial of early cardiac rehabilitation to improve survival and recovery in critically ill patients on extracorporeal membrane oxygenation

A multicentre, registry-embedded randomised controlled trial comparing the effect of a new model of early cardiac rehabilitation with standard care on strength, disability, survival and quality of life in critically ill adult patients requiring ECMO for acute cardiovascular disease.

Registry: Australian and New Zealand extracorporeal membrane oxygenation registry (EXCEL)

Use of registry for: baseline data, ICU and hospital interventions and outcome data

Why is registry involvement important for this trial?

Minimise data burden and ensures maximum efficiency
Allows for remote monitoring and internal consistency checks
Enables opportunity to recruit additional sites to support through the registry to improve recruitment rates if required

Changes to the registry to enable the trial:

Building additional data points into registry for trial data

Partnerships:

Involves an extensive research network including the ANZIC Research Centre, the ANZICS Clinical Trials Group, the Australian Physiotherapy Association, the Extracorporeal Life Support Association, the International ECMO Network, the Critical Care Research Group, Unity Health Network Toronto, College of Intensive Care Medicine, the Queensland Cardiovascular Research Network, and the International Forum of Acute Care Trialists.