Realising the potential of Australia’s clinical registries as a platform for clinical trials
School researchers will develop a guide that will lead the way in Australia to tap into the full potential of Clinical Quality Registries (CQR) as a platform for clinical trials, after securing a Commonwealth government tender.
Led by Head of School Professor Sophia Zoungas, and harnessing the School’s experts in CQR management, clinical trials, biostatistics, and data science, the project will provide a roadmap for registry-based trials that will be applicable to Australia’s over 100 CQRs.
Prof Zoungas is a leading clinical trialist, and believes the new guide will enhance Australia’s capacity for vital health research. “Clinical trials are integral to advancing clinical practice, but they are often stymied by the sheer complexity of clinical practice questions, funding shortfalls, ethical and logistical considerations, and the amount of time needed to run them,” she says. “Australia needs to look for solutions that enable trials that are faster and cheaper, but without compromising scientific rigour. Registry-based trials are a smart solution, and I’m proud that we’re able to share our great experience in this way.”
Clinical or patient registries collect a variety of standardized data associated with a particular medical condition or intervention with the aim of understanding clinical outcomes in the real-world setting. CQRs are a sub-set of registries with the primary aim of providing feedback to participating sites and clinicians on their performance, benchmarked against quality indicators, to reduce variation in care and improve patient outcomes.
A secondary use of CQRs – one that is often under-utilised – is acting as a platform for the conduct of clinical trials. Tapping into the existing infrastructure (including the datasets and data collection systems) of registries can reduce some of the logistical, financial and temporal barriers faced by traditional clinical trials.
CQRs can be harnessed for clinical trials in in many ways including:
- As a source of participant data (clinical and other) at baseline or set time points
- As a source of patients to recruit into a trial, without using registry data points
- Simultaneous enrolment of patients into the CQR and trial
Professor Susannah Ahern leads our Clinical Outcomes Data Reporting and Research Program, and is responsible for directly managing several CQRs, and provides national co-leadership of a registry special interest group. She says, “Registry-based trials are particularly useful in comparing and identifying existing interventions and models of care that lead to better patient outcomes in the real world, thus having a direct link to routine clinical care.”
The tender follows on the heels of the Commonwealth Department of Health’s National Clinical Quality Registry and Virtual Registry Strategy released in 2020, that underscored their desire to increase the connectivity and integration between registries and clinical trials.
The new guide will build awareness of the value of registry-based trials, what’s needed to run them, as well as best practice methodologies and evaluation techniques. It’ll serve as a valuable reference tool for clinical trialists, CQR operators, clinician and patient contributors to CQRs, and stakeholders drawn from health services, local health authorities, policy-makers and funders.
With 37 CQRs under our auspices – making us the single largest manager of CQRs nationally – our School brings significant clinical registry leadership to the project. We’ve led the way in developing approaches that support the embedding and/or integration of registries with clinical trial infrastructure to support registry-based trials.
Recent stand-outs have included the DIAAMOND trial, and ECMO-Rehab.
DIAAMOND was an adaptive study led by our Transfusion Research Unit that investigated the benefit and costs of avatrombopag in addition to conventional immunosuppressive therapies in aplastic anaemia patients. It leveraged the existing Aplastic Anaemia and Other Bone Marrow Failure Syndromes Registry for recruitment; and for baseline, outcomes and comparator data. Doing so enabled results to be rapidly translatable into policy and practice; it facilitated long-term follow up for rare disease patients, expanded Australia’s rare disease research capacity, and created a comparator group for a rare disease where randomized trials are not feasible.
ECMO-Rehab leveraged the existing EXCEL registry to deliver a multicentre RCT 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 extra-corporeal membrane oxygenation (ECMO) for acute cardiovascular disease. EXCEL was used for baseline, intervention and outcomes data, minimizing data burden, allowing for remote monitoring and consistency checking, and enabling recruitment of additional sites to support the through the registry if needed.
Find out more about the project on our website: monash.edu/medicine/sphpm/registries/registry-based-research/developing-a-best-practice-guide-for-registry-based-trials
Click here for more news from the School of Public Health and Preventive Medicine