Medullary Thyroid Cancer
Conditions
Keywords
effectiveness of risk mitigation,, knowledge and understanding survey,, drug utilisation study,, post marketing commitments
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.
Interventions
None listed
Sponsors
Genzyme, a Sanofi Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- N/A (all patients taking Caprelsa and all prescribers will be contacted for participation).
Exclusion criteria
- N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 12 months | At 12 months | Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs |
| Drug Utilisation Study: Concomitant use of QT-prolonging drugs at baseline | At baseline | Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs |
| Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 3 months | At 3 months | Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs |
| Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 6 months | At 6 months | Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs |
| Knowledge and Understanding Survey: Knowledge of the key safety issues pertaining to vandetanib | 2 months | QT prolongation/TdP Torsades, diarrhea, rash and other skin reactions- adequate or inadequate for each safety issue (defined by correct response). |
| Drug Utilisation Study: Use of vandetanib - duration of treatment at baseline | At baseline | Discontinuation, interruption, continuous |
| Drug Utilisation Study: Use of vandetanib - duration of treatment at 3 months | At 3 months | Discontinuation, interruption, continuous |
| Drug Utilisation Study: Use of vandetanib - duration of treatment at 6 months | At 6 months | Discontinuation, interruption, continuous |
| Drug Utilisation Study: Use of vandetanib - duration of treatment at 12 months | At 12 months | Discontinuation, interruption, continuous |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge and Understanding Survey: Previous exposure to vandetanib safety concerns other than product monograph or mandatory online training | 2 months | Participation in a trial on vandetanib, giving CME conferences, member of a data safety monitoring board. |
| Knowledge and Understanding Survey: Sources of information on key safety messages for vandetanib | 2 months | Product monograph, online training, Dear Healthcare Professional letter sent by AstraZeneca, company's sales forces, continuing medical education, conferences. |
| Knowledge and Understanding Survey: Practice characteristics | 2 months | Main geographical location, average days devoted to patient care, total number of medullary thyroid cancer patients followed up to date. |
Countries
Canada
Outcome results
None listed