Why GP data is the richest source of real-world evidence in the NHS — and how it's transforming drug development and market access.
Real world evidence (RWE) is clinical evidence derived from data collected outside of traditional randomised controlled trials — from routine clinical practice, electronic health records, patient registries, and observational studies. Unlike RCTs, RWE reflects how treatments perform in everyday clinical settings, in the full diversity of patients who will actually use them.
RWE is increasingly valued by regulators, payers and health technology assessment bodies including NICE, as it addresses questions that RCTs cannot: long-term safety, real-world effectiveness, adherence, and outcomes in patient subgroups typically excluded from trials.
UK general practice holds longitudinal health records for virtually the entire population. EMIS Web and SystmOne — the two dominant GP clinical systems — together cover over 95% of GP practices in England and hold decades of coded clinical data including diagnoses, prescriptions, investigations, referrals, and outcomes.
This makes primary care EHR data uniquely powerful for RWE. Hospital data captures acute episodes; primary care data captures the full disease journey — from first symptom to diagnosis, treatment, long-term management, comorbidity, and death.
Using historical EHR data to compare outcomes between patient groups. Rapid, low-cost, and increasingly accepted by regulators for post-authorisation safety and effectiveness studies.
Following patients forward in time within their normal care pathway, collecting additional data points not routinely recorded. Can be linked with patient-reported outcomes and biosamples.
Randomised at the practice level (cluster RCTs) or using pragmatic trial designs within real clinical workflows. Increasingly favoured for effectiveness research where blinding is impractical.
NICE increasingly requests RWE to support technology appraisals, particularly for managed access agreements and post-launch evidence generation. Primary care data is particularly valuable for NICE submissions because it reflects the population in which the treatment will be used — not the selected population of a regulatory trial.
All use of patient data for research requires appropriate governance. This includes Caldicott Guardian approval for each practice, Data Protection Impact Assessment (DPIA) where patient-level data is used, and either patient consent or an appropriate legal basis under UK GDPR. PCRA has established data sharing agreements across its network of practices to facilitate efficient, compliant RWE data access for sponsors.
PCRA has established data sharing agreements and experienced research leads across 30+ practices. Talk to us about your study design.
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