The 'Data Analysis and Real World Interrogation Network (DARWIN EU)' is an initiative created by the European Medicines Agency (EMA) to generate timely evidence from healthcare data sources from across Europe.
One area of research relates to estimating how common a specific condition is among the general population, and how drugs to treat that condition are used in people recently diagnosed with that condition. For regulators such as the EMA, it is important to have access to this kind information as it helps to understand the uptake of specific drugs over time.
The objective of each of those studies is to (1) describe how common a condition the EMA is particularly interested in among the general population, (2) to estimate the number of new and existing users of drugs used to treat that condition, (3) we summarise characteristics of patients taking those drugs in terms of their age, sex, other conditions they were diagnosed with or drugs they were prescribed at the time they start treatment. Where relevant, we also describe how the drugs are being used in terms of duration, dose or sequence of different medicines.
The EMA will request several studies of the same design to assess the use of drugs in people with conditions that are of particular interest to them. The first example will focus on the use of a medicine called “peginterferone” in people with a chronic infection of the liver (chronic hepatitis).
Primary care records provide a unique source of data for estimating the incidence and prevalence of diseases of regulatory interest and their specific drug treatments used in the community. The DARWIN EU initiative created by the European Medicines Agency (EMA) intends to draw upon such data to inform regulatory decision-making. To understand the utilisation of specific drugs in people with diseases of regulatory interest, EMA will commission several drug utilisation studies to the DARWIN Coordination Centre. Data sources will be mapped to the OMOP common data model (CDM) prior to analysis.
Study design: Cohort study
Population: All people in CPRD GOLD and CPRD Aurum with >=1 year of prior history comprise the source population. Among those, people with the pre-specified disease of regulatory interest will be selected.
Variables: Conditions and drug exposure based on prescription data based on SNOMED codes and RXNorm codes in the mapped data. In addition, the characteristics of patients being prescribed the drug(s) of interest will be described, and the use of the prescribed medicines assessed in terms of duration, dose or treatment sequence.
Disease/drug combinations of regulatory interest as expressed by EMA:
- Chronic Hepatitis B/C and use of peginterferone and specific antivirals
Additional disease/drug combinations of regulatory interest will be declared in future protocol amendments upon request by EMA to the DARWIN Coordination Centre.
Analyses:
(1) Incidence and/or prevalence of the disease of regulatory interest in the general population
(2) Incidence and/or prevalence of prescriptions of pre-specified drugs in newly diagnosed patients with disease of regulatory interest
(3) Summary characteristics of newly diagnosed patients at the time of starting treatment with pre-specified medicines
(4) Utilisation of pre-specified medicines in terms of duration of use, dose or treatment sequence.
All analyses will be stratified by age, sex, and calendar year where relevant.
Incidence and/or prevalence of disease of regulatory interest and/or pre-specified drug(s) of interest, Drug Utilisation
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Annika Jodicke - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Eng Hooi Tan - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Junqing Xie - Collaborator - University of Oxford
Kim López-Güell - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Marta Pineda Moncusi - Collaborator - University of Oxford
Martí Català Sabaté - Collaborator - University of Oxford
Mike Du - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Xintong Li - Collaborator - University of Oxford
Yuchen Guo - Collaborator - University of Oxford
HES Admitted Patient Care;CPRD Aurum Ethnicity Record;CPRD GOLD Ethnicity Record