Time intervals between key milestones of studies evaluating the effectiveness of Risk Minimisation Measures assessed by PRAC

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Other

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 retrospective cohort study of PASS overseen/discussed by PRAC is aimed to provide insights in the time intervals between key milestones of regulatory procedures for RMM effectiveness PASS assessed by PRAC 2016-2022 (follow-up on studies, EUPAS45978, EUPAS47563).
• Data analysis plan:
  This study mainly involved descriptive statistics to describe the cohort of PASS and duration of the intervals between key milestones. ; Categorical variables will be assessed using frequencies and percentages. Continuous variables will be assessed using medians and interquartile ranges or means and standard deviations (in case data follows a normal distribution). ; Next to descriptive analyses, data will be analysed stratified on characteristics including study design, type of indicator, effectiveness of RMM and type of RMM evaluated. ; This is done to evaluate whether these factors influence the duration of time intervals between key milestones.