Study type

Study topic

Human medicinal product
Other

Study type

Non-interventional study

Scope of the study

Other

If ‘other’, further details on the scope of the study

Discontinuation of aRMM tools
Non-interventional study

Non-interventional study design

Cohort
Population studied

Age groups

  • In utero
  • 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)
Study design details

Study design

This study will be a retrospective cohort study.

Main study objective

This retrospective cohort study aims to describe post-authorisation discontinuation of aRMM tools for centrally authorised medicinal products (CAPs) authorised with aRMM tools in the EU between July 2012 and December 2021.

Setting

This study will be a retrospective cohort study within a medicinal product cohort. This medicinal product cohort includes CAPs authorised in the EU between 1 July 2012 and 31 December 2021. From this medicinal product cohort, we established a study cohort of CAPs with aRMMs at the time of initial MA. We will identify aRMM tool discontinuations until 31 December 2024.

Comparators

None

Outcomes

- Time to discontinuation of the aRMM tools for CAPs authorised in the EU between July 2012 and December 2021;
- Category of aRMM tool that was discontinued, corresponding safety concern(s) of the discontinued tools;
- The type of regulatory procedure(s) involved in the discontinuation of the aRMM;
- The rationale for discontinuation of the aRMM tool.

Data analysis plan

We will use descriptive statistics to describe our study outcomes and the characteristics of the CAPs included in our study cohort.
To account for the time needed to accumulate sufficient data as justification for a discontinuation of aRMM tools, we will calculate the probability of discontinuation of aRMM tools using time-to-event analyses.
Regarding details on the rationale for aRMM tool discontinuation, we will perform thematic analysis.