Report on PRAC Pilot on Rapid Data Analytics

Study type

• Study topic:
  Other
• Study topic, other:
  Disease/Epidemiology study, A pilot on rapid data analytics (referred to in this report as RDA) coordinated by the European Medicines Agency (EMA)
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Case-control

Population studied

• Short description of the study population:
  NA
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  100000

Study design details

• Main study objective:
  A pilot on rapid data analytics coordinated by the EMA was performed with the PRAC from November 2019 to January 2021. Its aim was to test the feasibility and usefulness of a process for rapid identification, analysis and reporting of results of epidemiological questions that may arise in in the context of regulatory assessments.
• Data analysis plan:
  Please refer to the executive summary

Documents

Study results

PRAC Pilot Rapid Data Analytics - Executive summary