Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment Using the Novel Analysing Stakeholder Safety Engagement Tool (ASSET)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Stakeholder engagement analysis
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Theory-based case study with qualitative content analysis

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  VALPROIC ACID
• Medical condition to be studied:
  Epilepsy

Population studied

• Short description of the study population:
  Patient and healthcare professional representatives at the public hearing and dedicated stakeholder meeting for the valproate teratogenicity and risk management assessment by the Pharmacovigilance Risk Assessment Committee (PRAC) at EMA in 2017/2018.
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  60

Study design details

• Main study objective:
  (1) Analyse stakeholder input at public hearing and dedicated meeting for the 2017/18 EU procedure on valproate teratogenicity, (2) Draw proposals for enhancing PRAC engagement.
• Outcomes:
  Stakeholder input content analysis findings and derived proposals for enhancing engagement between regulators, patients and healthcare professionals
• Data analysis plan:
  Development of content analysis tool based on established theories with coding scheme and rules, testing of tool prior to application, peer examination of research design, data analysis applyig tool and adhering to coding rules

Documents

Study results

Bahri P, Morales D, Inoubli A, Dogne JM, Straus S_Valproate hearing ASSET analysis and PRAC engagement proposals

Study publications

Bahri P, Morales DR, Inoubli A, Dogné JM, Straus SM. Proposals for engaging pat…