Implementation of EU risk minimisation measures for medicinal products in clinical guidelines

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  The implementation of product specific risk minimization measures (RMMs)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Qualitative study including document analysis and qualitative interviews

Population studied

• 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)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  47500000

Study design details

• Main study objective:
  The study aims to describe the processes for updating clinical guidelines with regulatory action and the role of clinical guidelines in the implementation of product specific RMMs using five defined cases of disease priority areas and active substances. The five cases represent medicinal products that are prescribed by a broad selection of health care professionals.
• Data analysis plan:
  The extent to which information products cover the RMM will be graded based on the results of the coding of information products. The analysis of the semi-structured interviews involves an inductive content analysis based on a close line-by-line reading of the responses and developing a conceptual coding scheme based on the major themes in the interview guide.

Documents

Study results

D3_ROC04_SC01_Lot4_IMPACT_study_report_final_v2_abstract