Review of PRAC assessed PASS evaluating risk minimisation measures (RMM) (EffectiveRMM2)

Study type

• 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

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Document review

Population studied

• 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:
  This systematic review of PASS overseen or discussed by PRAC is aimed to provide a better understanding of factors associated with PASS that did not lead to a conclusion on the effectiveness of RMM, and to gain insights into factors associated with (in)effectiveness of RMM as presented in conclusive PASS.
• Data analysis plan:
  For each PASS evaluating RMM effectiveness we assess if the PASS was conclusive (i.e. PRAC was able to draw conclusions on RMM effectiveness based on the PASS results) or inconclusive (i.e. the PASS did not allow to draw firm conclusions on RMM effectiveness). We will use descriptive statistics to identify factors (e.g. specific study characteristics) associated with (in)effective RMM. A qualitative thematic analysis will be performed to identify methodological and other limitations that may have rendered the PASS inconclusive.