Developing a best practice guide for registry-based trials
Developing a best practice guide for registry-based trials
Funding source, year
Commonwealth Department of Health, 2024
Summary
Clinical trials are a vital source of evidence to advance high-quality, effective and cost-effective health care. However, traditional clinical trials are often costly, logistically challenging, and involve long time-frames. Registry-based trials leverage existing patient registries – which comprise rigorous, relevant datasets and data collection systems to monitor patient care and outcomes – to drive faster, cheaper clinical trials, thereby expanding Australia’s research capacity and creating better opportunities for improved clinical health outcomes for consumers.
This project draws on the significant expertise contained within our School across registry science, data science, clinical trials, biostatistics and consumer and community engagement to develop a guide that will build understanding around registry-based trials and how to run them.
Project purpose and target audience
The purpose of the Guide is to increase understanding of:
- the characteristics of registries and interventions that are most suitable for registry-based trials
- what resources, capacity, and capability are required for a registry to be a platform for registry-based trials
- best practice methodologies and approaches for undertaking registry-based trials
The Guide is tailored for the following key audiences:
- clinical trial researchers,
- national clinical quality registry (CQR) – and other registry – operators,
- clinicians,
- registry participants in clinical trials (consumers and community members), and
- providers (including health services / jurisdictions / policy makers / funders.
The Guide also includes practical resources such as flowcharts and checklists to support implementation.
Practical resources to support Guide implementation:
- Registry-based trial decision tree (PDF)
- Checklist for deciding on a registry-based trial – for trialists (xlsx)
- Checklist for deciding on a registry-based trial – for registries (xlsx)
- Registry-based trial request template (docx)
Project team
Our School is Australia’s single largest manager of CQRs, and this project draws on the significant methodological and operational experience of staff from a number of disciplines, including evidence synthesis, clinical trials, data science, registry science, qualitative research and biostatistics. We have been at the forefront of the design and delivery of 13 registry-based trials over the past few years and are leading innovation and advocacy for this methodology.
Contact
Please contact Tsharni Zazryn (Project Manager, SPHPM): regtrialguide@monash.edu