Population-level DUS analyses

The European Medicines Agency (EMA) and the European Medicines Regulatory Network established a coordination centre to provide timely and reliable evidence on the use, safety and effectiveness of medicines for human use, including vaccines, from real world healthcare databases across the European Union (EU). This capability is called the Data Analysis and Real World Interrogation Network (DARWIN EU^®).

Expression of Interest Call now open for Data Partners.

More information can be found here.

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Study Type

Population-level DUS analyses are classified as ‘off the shelf’ studies.

Study Design

Population-level cohort.

Participants

Population-level analyses will include the entire source population with at least some time (typically 1 year) of data visibility available before start of study period.

Additional eligibility criteria will apply as follows:

Analyses of incidence of drug use will exclude prevalent users of the same drug/drug class on index date and/or in the previous (washout) year
The study population could be restricted to a specific subpopulation with certain socio-demographic e.g., age 18 or older, or with a history of a pre-specified clinical feature/s, e.g., people with a prior diagnosis of rheumatoid arthritis
In some cases, a minimum follow-up will be requested e.g., for treatment pattern analyses

Outcome/s

The following outcome/s will be obtained, potentially stratified by pre-specified criteria (age bands, sex, calendar year or month):

Population-based incidence rates of use of a drug/drug class over calendar time. Periods could be calendar days, weeks, months, quarters or years.
Population-based prevalence of use of a drug/drug class on a given time point (point prevalence) or within a given time period (period prevalence). Periods could be calendar days, weeks, months, quarters or years.

Follow-up

Follow-up will start on a pre-specified calendar time point pre-defined as index date , e.g., 1^st January or 1^st of each month, and continue for a pre-specified time period, typically week, month, quarter or year.

Analyses

Population-level DUS analyses use the same analytical pipeline as Population-level descriptive epidemiology studies (see separate subsection). Incidence rates will have number of new users (with a pre-specified washout) in the numerator, and total population as person-years (except prevalent users) in the denominator. Prevalence will be calculated as number of users (prevalent or new) over whole source population at a specific time point (i.e., point prevalence) or over a specific time window (i.e., period prevalence). Both may be stratified by socio-demographics (e.g., age bands or sex) and/or calendar period. Additional criteria (e.g. disease severity/duration) may need to be considered and integrated as pre-specified in future studies.

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