Assessing the provenance and integrity of routinely collected healthcare systems data for clinical trials

20 Jul 2022

Healthcare systems data has the potential to transform the conduct of clinical trials, and many trialists intend to use them more for recruitment, outcomes, and follow-up. There are excellent examples of trials that have benefitted from their use, such as the RECOVERY and PRINCIPLE trials investigating potential treatments for Covid-19.  

But a key challenge is that trial sponsors need to confirm the provenance and integrity of these data to satisfy regulatory standards. The collaborative group led by our Conduct Methodology team, demonstrated the integrity of two important NHS Digital datasets in our report, and this has now been highlighted through our commentary in August’s issue of The Lancet Digital Health.  

We urge data providers to take these necessary steps to support assessments of provenance and integrity for all relevant datasets. This step will make trials more efficient and consequently lead to faster improvements in healthcare for all.

The Healthcare Systems Data for Clinical Trials Collaborative Group:

• MRC CTU at UCL: Macey Murray, Sharon Love, James Carpenter, Max Parmar, Matt Sydes. 
• NHS Digital: Suzanne Hartley, Heather Pinches. 
• University of Oxford (Big Data Institute): Martin Landray, Marion Mafham. 

Further information:

• The Lancet Digital Health commentary
• Detailed report "Use of NHS Digital datasets as trial data in the UK"
• Health Data Research UK news article
• Health Data Research UK infographic