Table 3 Common challenges to registry development encountered and addressed
Challenge | Resolution | Examples |
|---|---|---|
Generating and sustaining engagement, demonstrating value | Highlighting advantages for: • Patients: Knowing their data will help create a national picture of the condition, and that their hospital is participating in benchmarking for best practice | • Patient representation on the Steering Committee • Newsletters, website information and presentations for patient/community groups |
• Sites and clinicians: Access to own and other data for comparison and benchmarking, access to a peer network, opportunities for projects for young investigators, access to data on rare conditions where trials are difficult | • Direct access to own data • Hospital data reports • Participation in registry committees • Research project opportunities, supported by LaRDR team | |
• Industry, policy-makers and others: Access to real world data including on treatment sequencing, uptake of new, high-cost or high-risk therapies, reasons for discontinuation, data to support regulatory applications and health service planning | • Presentations at scientific meetings and to government • Annual open investigator meetings • Peer-reviewed publications • Commissioned reports | |
Ethics and governance | • ‘Opt out’ consent model: works well for engaging patients and obtaining clinical data but unfamiliar to some (including some HREC & governance committees) • Historically fragmented HREC system: time-consuming to apply individually to local HREC and governance committees | • Engagement with site HREC and governance committees • Seek written consent in future to obtain biological samples • Transition to national mutual acceptance ethics arrangements |
Sustainability | • Pilot phase and managed roll-out: Essential to recognise and address operational problems early, but few results generated during this stage • Site resources: generally very limited, alleviated somewhat by per-patient payments provided initially • Secure ongoing funding: always challenging until data mature and can generate analyses and peer-reviewed publications | • Respond to feedback, and keep stakeholders informed of progress and plans • Per-patient payments: even modest support is valuable and permits managers to allocate staff time for data entry • Communicate potential of registry data and how industry, clinicians, researchers, government agencies can access |
Data and access | • Data entry burden: Find a balance between collecting all possible data, determining what is feasible to collect, and what will actually be used –determining an initial minimum dataset for the registry, which is subject to ongoing review and potential for additions (e.g. patient-reported outcomes) | • Include stakeholders in planning to consider feasibility: registry scope and the content of the dataset, noting that data collectors will likely not be experts in this field • Provide training for site staff and access to ongoing support and resources, and data definitions • Data validation committee and periodic audits of data completeness and utilisation • Per-patient payments for data |
• Maximising data access while maintaining data security | Use of institutional secure e-research platform (SeRP) permits authorised users to access and analyse data within a data ‘safe haven’, under control and supervision of registry data custodian | |
Research activities | • Promoting research, especially early and before many patient outcomes available | Clear guidelines on participation Promote project and authorship opportunities Inclusivity Supporting younger researchers Annual research meetings |