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Overview

The DSRU has a licence to access to CPRD, the NHS observational data service, based in the UK.

Our epidemiologists have experience of working with CPRD data and will be pleased to discuss a potential CPRD study with no commitment.

CPRD provides unique opportunities for researchers to harness the power of large multi-linked observational datasets, while protecting patient confidentiality:

  • All data are anonymised
  • CPRD collects fully-coded patient electronic health records from GP practices across the UK
  • Over 5 million currently registered and active patients
  • Representative of the UK population with respect to age, gender and ethnicity
    linkage to secondary care and registry data available

CPRD Data

The DSRU team uses CPRD data in a variety of study designs.

DSRU uses CPRD data to investigate various research questions in pharmacovigilance and pharmacoepidemiology, including:

  • Studies to fulfill post-authorisation regulatory requirements (PASS studies)
  • Pre-authorisation applications
  • Drug utilisation studies
  • Safety studies investigating exposures and outcomes of interest over time

The DSRU is in good company: CPRD data are used worldwide by regulators, academic researchers and the life science industry for observational and interventional public health studies. Over 1,800 studies have been published to date.

Case Study

Extension of product licence

  • We were approached by a company which requested a CPRD study to support extension of a product licence to a new age group of patients.
  • CPRD was chosen because it reflects real-world use from electronic medical records and can provide information on use in groups which are not covered by the current licence.
  • Real-world data is becoming used more frequently to support licence extension applications and has several advantages over clinical trials, including lower costs.
  • The DSRU was able to advise that regulators frequently accept this type of study to support license extension applications.
  • A CPRD study was proposed to provide data on safety and utilisation of the medicinal product in an age group not covered by the current licence.
  • The study population comprised patients who received the product in the primary care setting in the UK within the new age group of interest.
  • Variables collected included age, sex, daily dose, duration of treatment, concomitant medications, prior medications, medical history, safety events, weight at baseline, test results at baseline and 3 months after starting treatment.
  • The DSRU team conducted the study on the CPRD GP Online Data (GOLD) database in the UK.
  • The study was completed within 8 weeks, including data extraction, preparation, analysis and production of final report.

Case Study

Application for new therapeutic indication

  • We were approached by a company which requested a CPRD study to support the application for a variation of a product licence to add a new therapeutic indication for use in a specific age group of patients.
  • The DSRU advised that regulators frequently accept this type of study to support license variation applications.
  • A CPRD study was proposed to provide data on demographic, safety and utilisation of the medicinal product within this age group.
  • The study population comprised patients who received the product in the primary care setting in the UK.
  • Variables collected included age, sex, daily dose, duration of treatment, concomitant medications, prior medications, medical history, safety events, weight at baseline.
  • The DSRU team conducted the study on the CPRD GP Online Data (GOLD) database in the UK.
  • The study was completed within 8 weeks, including data extraction, preparation, analysis and production of final report.