Review of studies evaluating the effectiveness of risk minimisation measures evaluated by PRAC (EffectiveRMM)

Study type

• Study topic:
  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Descriptive study of industry sponsored PASS
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Population studied

• Short description of the study population:
  Data will be considered eligible when originating from industry-sponsored PASS evaluating the effectiveness of RMM submitted and assessed by PRAC between 2016 and 2019.; All EU-RMP category 1, 2, or 3 PASS evaluating the effectiveness of RMM that were submitted to and assessed by the PRAC between 1 January 2016 and 31 December 2019 will be included in the study cohort.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • 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)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  The aim of this review of industry-sponsored post-authorisation safety studies (PASS) evaluating the effectiveness of risk minimisation measures (RMM) assessed by PRAC between 2016 and 2019
• Data analysis plan:
  A review of industry sponsored PASS evaluating effectiveness of RMMS was performed and extracted variables were analysed with descriptive statistics. Variables were summarised by the number and percentage per category.