Harnessing longitudinal population data to transform disease surveillance, clinical practice research, and national health equity strategies.

The Next Era of Real-World Evidence: How CPRD and the MHRA Are Transforming UK Population Health

CPRD appoints Dr Puja Myles as its new Director. Discover her vision for UK real-world data, pharmacoepidemiology, and the future of MHRA-led population health research.

The Clinical Practice Research Datalink (CPRD) remains one of the most powerful real-world data assets in global public health a longitudinal, nationally representative dataset spanning more than 60 million patients. With increasing demand for high-quality real-world evidence (RWE) in regulatory science, safety surveillance, AI validation, and health policy, the appointment of Dr Puja Myles as the new Director of CPRD arrives at a pivotal moment for UK health data leadership.

Who is Dr Puja Myles?

Dr Puja Myles is a public health physician, epidemiologist, and internationally recognised expert in real-world data. Before joining the MHRA, she spent many years in academic public health, specialising in the use of observational datasets to answer complex questions about disease risk, clinical practice, and population outcomes.

Her background includes:

• PhD in Epidemiology
• Fellow of the Faculty of Public Health (FPH)
• Senior Fellow of the Higher Education Academy (HEA)
• Extensive experience teaching and supervising public health researchers
• A track record of methodological innovation in population health research

Dr Myles joined the MHRA in 2017 as:

• Head of Observational Research, and
• Joint Interim Director of CPRD

Her new appointment formalises her leadership at a time when CPRD’s role in regulatory-grade real-world evidence has never been more critical.

What CPRD Does and Why It Is Globally Important

The Clinical Practice Research Datalink (CPRD) is a real-world research service jointly delivered by:

• The Medicines and Healthcare products Regulatory Agency (MHRA), and
• The National Institute for Health and Care Research (NIHR)

operating under the Department of Health and Social Care (DHSC).

CPRD collects anonymised primary care data from GP practices across the UK and links it to:

• Hospital Episode Statistics (HES)
• Mortality data from ONS
• Cancer registries
• Pharmacy and prescribing datasets
• Screening programmes
• Socioeconomic indices

The result is one of the most widely used longitudinal population health datasets in the world.

CPRD in Numbers

• More than 60 million patient records
• 18 million currently registered patient records
• 30+ years of continuous research use
• Over 3,000 peer-reviewed publications
• Research informing guideline development, drug safety, pharmacoepidemiology, health service evaluation, and policy formulation

The Significance of Puja Myles’ Leadership

Dr Myles steps into the role at a time when regulatory bodies, HTA agencies, and industry partners increasingly depend on RWE to:

• Support regulatory submissions and safety surveillance
• Inform HTA evaluations (NICE, SMC, AWMSG, international agencies)
• Validate AI-driven clinical tools through real-world datasets
• Design target trials using observational data
• Understand clinical practice variation and health inequalities
• Evaluate policy impacts across the NHS

Her expertise in observational methods and public health ensures CPRD continues to generate evidence that is:

• Scientifically rigorous
• Regulator-ready
• Transparent and reproducible
• Aligned with global best practice (STROBE, ENCePP, HARPER, FDA RWE Guidance, EMA RWD Reflection Paper)

CPRD’s Modern Role: Beyond Research

Under Dr Myles’ leadership, CPRD is increasingly positioned as:

1. A Strategic Public Health Asset

Supporting disease surveillance, risk stratification, and population-level health planning.

2. A Regulatory-Grade RWE Infrastructure

Accelerating safety assessment, post-authorisation studies, and signal detection.

3. A Partner for NHS Transformation

Providing analytical insights into care pathways, clinical variation, and resource use.

4. An Enabler of AI and Digital Health Validation

Providing real-world datasets necessary for testing, calibration, fairness assessment, and post-deployment monitoring.

Looking Ahead: CPRD’s Vision Under Dr Myles

Dr Myles is expected to lead CPRD into a new phase focused on:

• Modernising data linkage
• Strengthening transparency and data governance
• Supporting the regulatory use of RWD
• Improving data access for researchers and industry partners
• Enhancing methodological quality and reproducibility
• Expanding international collaboration
• Driving innovation in public health analytics

Her background in both public health practice and methodological epidemiology positions CPRD to remain globally influential in shaping how real-world evidence informs safety, effectiveness, and policy.

Reference List

CPRD – Official Website
https://www.cprd.com/

MHRA – Medicines and Healthcare products Regulatory Agency
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

NIHR – National Institute for Health and Care Research
https://www.nihr.ac.uk/

ONS – Office for National Statistics
https://www.ons.gov.uk/

NHS England – Secondary Uses Service (SUS) & HES
https://digital.nhs.uk/data-and-information/data-tools-and-services/data-services/hospital-episode-statistics

NICE – Real-World Evidence Framework (2023)
https://www.nice.org.uk/corporate/ecd9/resources/nice-realworld-evidence-framework-pdf-1502082041277

EMA – Real-World Evidence Reflection Paper (2023)
https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-use-real-world-methodologies-support-regulatory-decisions_en.pdf

FDA – Real-World Evidence Guidance
https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence

STROBE Guidelines (Epidemiology Reporting)
https://www.strobe-statement.org/

ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance)
https://www.encepp.eu/