Vandetanib Risk Minimisation Effectiveness

Study Overview
=================
Brief Summary
-----------------
Effectiveness of risk minimisation interventions for vandetanib in Canada

Detailed Description
-----------------
As part of the new drug approval process in Canada, AstraZeneca has committed to Health Canada to conduct a Drug Utilization Study among patients recently treated with CAPRELSA (vandetanib) and a Knowledge and Understanding Survey among the prescribing physicians to determine whether the product monograph, communication plan, and educational material developed by AstraZeneca Canada for vandetanib are adequate to provide knowledge about the potential risks associated with this product, and if other medications taken concomitantly with vandetanib are managed adequately.

Official Title
-----------------
Effectiveness of Risk Minimisation Interventions for Vandetanib in Canada

Conditions
-----------------
Medullary Thyroid Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - N/A (all patients taking Caprelsa and all prescribers will be contacted for participation). Exclusion Criteria: - N/A

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Caprelsa Patient<br>All patients treated with Caprelsa in Canada and participating in the restricted distribution programme. | |
| Caprelsa Prescriber<br>All physicians having prescribed at least one dose of Caprelsa and registered as a certified prescriber of Caprelsa in Canada. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge and Understanding Survey: Knowledge of the key safety issues pertaining to vandetanib | QT prolongation/TdP Torsades, diarrhea, rash and other skin reactions- adequate or inadequate for each safety issue (defined by correct response). | 2 months | 
| Drug Utilisation Study: Use of vandetanib - duration of treatment at baseline | Discontinuation, interruption, continuous | At baseline | 
| Drug Utilisation Study: Use of vandetanib - duration of treatment at 3 months | Discontinuation, interruption, continuous | At 3 months | 
| Drug Utilisation Study: Use of vandetanib - duration of treatment at 6 months | Discontinuation, interruption, continuous | At 6 months | 
| Drug Utilisation Study: Use of vandetanib - duration of treatment at 12 months | Discontinuation, interruption, continuous | At 12 months | 
| Drug Utilisation Study: Use of vandetanib - dosage at baseline |  | At baseline | 
| Drug Utilisation Study: Use of vandetanib - dosage at 3 months |  | At 3 months | 
| Drug Utilisation Study: Use of vandetanib - dosage at 6 months |  | At 6 months | 
| Drug Utilisation Study: Use of vandetanib - dosage at 12 months |  | At 12 months | 
| Drug Utilisation Study: Concomitant use of QT-prolonging drugs at baseline | Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs | At baseline | 
| Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 3 months | Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs | At 3 months | 
| Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 6 months | Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs | At 6 months | 
| Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 12 months | Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs | At 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge and Understanding Survey: Practice characteristics | Main geographical location, average days devoted to patient care, total number of medullary thyroid cancer patients followed up to date. | 2 months | 
| Knowledge and Understanding Survey: Previous exposure to vandetanib safety concerns other than product monograph or mandatory online training | Participation in a trial on vandetanib, giving CME conferences, member of a data safety monitoring board. | 2 months | 
| Knowledge and Understanding Survey: Sources of information on key safety messages for vandetanib | Product monograph, online training, Dear Healthcare Professional letter sent by AstraZeneca, company's sales forces, continuing medical education, conferences. | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
effectiveness of risk mitigation,, knowledge and understanding survey,, drug utilisation study,, post marketing commitments