Healthcare Professional Survey to Assess the Effectiveness of Risk Evaluation and Mitigation Strategy for Dulaglutide (36 Month) (H9X-MC-B003)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Survey Design

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DULAGLUTIDE

Population studied

• Age groups:
  • 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)
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  This study aims to assess the impact of a Risk Evaluation and Mitigation Strategy (REMS) for dulaglutide on healthcare provider knowledge regarding the risk of pancreatitis and the potential risk of medullary thyroid carcinoma associated with dulaglutide therapy. A threshold of at least 80% will be used to assess healthcare provider understanding of the key risk messages.
• Outcomes:
  The target for the assessment of the effectiveness of the 36 month REMS effectiveness assessment survey is that at least 80% of participating HCPs demonstrate awareness of the key risk messages in the REMS program.
• Data analysis plan:
  Data collected from the survey will be reported as descriptive statistics. Frequency distributions with 95% CIs will be calculated for respondent responses to all questions that address the survey objectives