The data-enabled trials area aims to support the cardiovascular clinical trials community. The resources shared have been developed as part of this program of work or highlighted by our community.
Guidance
The cardiovascular clinical trials community identified the requirement for guidance around what datasets are available and how these can be accessed for use within clinical trials. The below links outline key datasets across the UK.
Data Integrity
One of the key issues for clinical triallists planning to use healthcare systems data is uncertainty around how regulators view this data. Dr Macey Murray has led a project with the ‘Healthcare systems data for clinical trials group’ – Use of NHS Digital datasets as trial data in the UK: a position paper. The project has focused on two important NHS Digital datasets – the Hospital Episode Statistics Admitted Patient Care dataset and the Civil Registration of Deaths dataset. The team have assessed the data integrity for these datasets demonstrating the data flow and documentation in place for each.
Based on the findings from this project, the team have shown that HES APC and CRD datasets satisfy the assessment criteria that demonstrate they are reliable transcribed copies of the original source data.
Read the full paper here.
The team also make some helpful recommendations about documenting the use of this data within the Trial Master File (TMF) – and have produced a helpful template for the TMF Routine Dataset Justification Template.
Data Retention and Sharing – Considerations
Data Retention
Regulatory requirements mandate that clinical trial data is stored for a prolonged period of time. Historically there have been some challenges retaining routinely-collected data for this length due to data providers mandating short periods in contracts. Providers are now aware of the challenges and will usually work to ensure agreements provided allow for appropriate data retention. Teams should review contracts to make sure their trial requirements are adequately documented before agreements are signed.
Data Sharing
Onward ethical and secure data sharing for data re-use projects is rapidly becoming best practice for clinical trials, with an aim to maximise the benefits of the research for patients, the public and the health and care system. However, there are a number of logistical challenges with sharing data – differing regulatory frameworks between countries, differing standards (for example, CDISC/DASH, OMOP.) and possibly selecting a platform to allow data sharing. The MRC Clinical Trials Unit (CTU) at UCL published a paper ‘Sharing data from clinical trials: the rationale for a controlled access approach‘ with suggested guiding principles for data sharing, and UKCRC Registered CTU sets out ‘Considerations for a Participant Data Sharing SOP’. Ensuring routine data can be used in onward data sharing projects is a key consideration before signing agreements.
Useful Links
Dr Macey Murrays webinar on ‘Assessing data provenance and integrity of NHS Digital datasets for clinical trials’
‘Demystifying access to routine data’ – Suzanne Hartley (Trials Methodology Research Partnership / HDRUK) talks about Organisational and Trial readiness, Applications, Data sharing and Data retention.
Guidance for Good Randomised Clinical Trials – a useful guide laying out key principles of RCTs. Section 4 discusses making optimal use of pre-existing resources.