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:
  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:
  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.

Documents

Study publications

Grupstra R, Goedecke T, Scheffers J, Strassmann V, Gardarsdottir H. Review of S…