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.