Implementation of controlled access to and distribution of medicinal products in European Union (CONTROL-EU)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

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

Study drug and medical condition

• Name of medicine:
  ASPAVELI 1080 MG - SOLUTION FOR INFUSION

  FINTEPLA

  REVLIMID

  SOLIRIS

  SPRAVATO

  STRIMVELIS

  UPTRAVI

  YESCARTA
• Study drug International non-proprietary name (INN) or common name:
  AUTOLOGOUS CD34+ ENRICHED CELL FRACTION THAT CONTAINS CD34+ CELLS TRANSDUCED WITH RETROVIRAL VECTOR THAT ENCODES FOR THE HUMAN ADA CDNA SEQUENCE

  AXICABTAGENE CILOLEUCEL

  ECULIZUMAB

  ESKETAMINE HYDROCHLORIDE

  FENFLURAMINE HYDROCHLORIDE

  LENALIDOMIDE

  PEGCETACOPLAN

  SELEXIPAG
• Anatomical Therapeutic Chemical (ATC) code:
  (A08AA02) fenfluramine

  fenfluramine

  (B01AC27) selexipag

  selexipag

  (L01XL03) axicabtagene ciloleucel

  axicabtagene ciloleucel

  (L03) IMMUNOSTIMULANTS

  IMMUNOSTIMULANTS

  (L04AJ01) eculizumab

  eculizumab

  (L04AJ03) pegcetacoplan

  pegcetacoplan

  (L04AX04) lenalidomide

  lenalidomide

  (N01AX14) esketamine

  esketamine

  (N03AX26) fenfluramine

  fenfluramine

  (N06AX27) esketamine

  esketamine

  (S01XA31) pegcetacoplan

  pegcetacoplan

Population studied

• Short description of the study population:
  It is anticipated that the list will include all of the following stakeholders: ; - National competent authorities / drug regulatory agency / health inspectorates ; - Marketing authorisation holder / distributors of each of the eight medicinal products ; - Professional organisations relevant for prescribing/dispensing the eight medicinal products (including physicians and pharmacists) ; - Patient / care giver organisations relevant for the eight medicinal products
• Estimated number of subjects:
  109000000

Study design details

• Study design:
  A mixed-methods approach is foreseen including document analysis, a quantitative analysis of cross-sectional survey data as well as a qualitative analysis of stakeholders’ perceptions.
• Main study objective:
  The study aims to describe processes in and national experiences of eight European countries (Austria (AT), Greece (GR), Latvia (LV), Netherlands (NL), Portugal (PT), Slovenia (SI), Spain (ES), and Sweden (SE)) of implementing the EU pharmacovigilance legislation on risk minimisation measures (RMM) with an emphasis on controlled access programmes (CAP) and controlled distribution systems (CDS) using eight centrally authorised medicinal products as examples.
• Setting:
  Eight European countries (Austria (AT), Greece (GR), Latvia (LV), Netherlands (NL), Portugal (PT), Slovenia (SI), Spain (ES), and Sweden (SE))
• Data analysis plan:
  Quantitative analyses will entail descriptive statistics, univariate and bivariate analyses will be conducted according to stratifying variables. The analysis of the semi-structured interviews involves a 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.