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®).

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Patient-level DUS analyses

Study Type/s

Patient-level DUS analyses are classified as ‘off the shelf’ studies. Patient-level DUS will offer the possibility to include population-level DUS analyses as part of the same analysis.

Study Design

New drug/s user cohort

Participants

Patient-level DUS analyses will include one or more cohort/s of incident drug users with at least 1 year of data visibility, and no use of that same drug/drug class in that previous year.

Additional eligibility criteria could apply as follows:

  • Source population could be restricted to a specific subpopulation with certain socio-demographic or clinical feature/s, e.g., people with a diagnosis of rheumatoid arthritis who then start to take a disease-modifying anti-rheumatic drug (DMARD)
  • Additional restriction/s could apply as per product label, indication, or study aim/s, e.g., people aged 18 or older at the time of therapy initiation

Follow-up

Participants will be followed up from the date of therapy initiation (index date) until the earliest of loss to follow-up, end of data availability, or death. Patients might be censored at the time they discontinue treatment or switch to an alternative therapy.

Outcome/s

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

  • New drug user cohort/s patient-level characteristics on or before index date
  • Indication (where available)
  • Initial dose/strength (as prescribed/dispensed at therapy initiation, where available)
  • Cumulative use within a pre-specified time period (e.g. 1 year) based on number of prescriptions and dose/strength
  • Treatment duration
  • Count of repeated prescriptions during a pre-specified time period (e.g. 1 year)

Analyses

Patient-level DUS analytics will include:

  • Large-scale characterisation of patient-level features based on code/concept and descendants, including socio-demographics, comorbidity, and previous medicine/s use any time in history, and in the year, and/or in the month previous to index date
  • Frequency and % of indication/s, based on pre-specified list of diagnoses recorded before therapy initiation (where available)
  • Reporting of minimum, p25, median, p75, and maximum initially prescribed or dispensed dose/strength (where available)
  • Reporting of minimum, p25, median, p75, and maximum cumulative use within a pre-specified time period (e.g. 1 year)
  • Reporting of minimum, p25, median, p75, and maximum treatment duration
  • Reporting of minimum, p25, median, p75, and maximum number of repeated prescriptions of the index drug during a pre-specified time period (e.g. 1 year)
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