OBJECTIVES: National Health Services England (NHSE) routinely collects national healthcare data, which is provisioned for research for approved researchers to access for approved projects. Despite this wealth of data, the timely, secure, and continuous access during and after the COVID-19 pandemic challenged the traditional data sharing model. Evidera and AstraZeneca piloted NHSE's Secure Data Environment (SDE), part of the NHS Research SDE Network, for their burden of COVID-19 study (INFORM). We aim to describe this case study.

METHODS: INFORM investigates COVID-19 burden focusing on vulnerable populations, leveraging 5+ billion linked health records with minimal lag on 25% random sample of England's population on primary and secondary care visits, vaccination, COVID-19 surveillance, primary care medication dispensations, socio-demographics, and mortality.

RESULTS: This pilot revealed priorities to focus the diligent scrutiny to optimize data-access application process, new user qualification and onboarding, secured output review and release process, and IT infrastructure capabilities. Study findings were incorporated into dossiers for submission to health authorities (e.g., EMA, MHRA, NICE), published in Lancet Regional Health, and disseminated through conference abstracts, presentations, and institutional channels. Despite COVID-19 transitioning to an endemic phase, immunocompromised populations continued to face a disproportionately higher risk of COVID-19 hospitalization, ICU admissions, and deaths. Study findings have raised awareness among healthcare-decision makers, physicians, patients, and their families, and informed preventive behaviours and strategies.

CONCLUSIONS: The INFORM study’s success is ascribed to the collaboration between NHSE, Evidera, AstraZeneca, and advisory clinical experts, who relied on collaboration among multi-disciplinary teams including scientists, data analysts and programmers, and specialists from their legal, privacy, IT, operations, and compliance functions.