A Seven Year Registry
A Seven Year Registry
Columns
Content
Situation
Situation
- Ensuring awareness of Pregnancy Registry among Healthcare Providers and Women who become pregnant while receiving treatment for their Multiple Sclerosis in order to capture as many eligible patients as possible
- The Registry is available in 19 countries, with one referring site per country
- Detecting and recording the following outcomes:
- Spontaneous abortion
- Major and minor congenital malformations
- Pregnancy outcome: stillbirth, elective terminations, preterm birth, full-term live birth
- Information on the pregnancy outcome and infant follow-up to approximately one year of age
Content
Design and Type
Design and Type
An international post authorization safety study (PASS) – A prospective, observational cohort study (Registry) of pregnancy outcomes in women with multiple sclerosis (MS) exposed to immuno-modulator treatment in 19 countries: Australia, Austria, Belgium, Canada, Denmark, Czech Republic, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom and USA.
Purpose
Purpose
To compare maternal, fetal and infant outcomes in women exposed to immuno-modulator treatment with the outcomes of unexposed external comparison groups.
Actions
Actions
- An awareness plan was put in place. All Registry awareness activities will be targeted to HCPs in participating countries. The Registry does not recruit patients directly
- Used a Registry Coordinating Center in North America and a Coordinating Registry Physician (CRP) model in Rest of World by engaging Syneos Health’s expertise in Registry Start-Up across 19 countries
- Collection and analysis of data from multiple data sources
Results
Results
- Achieved increased level of awareness based on number of enrolled cases in the Registry
- Fit-for-purpose Pregnancy Registry model based on healthcare provider and local country requirements
- Established scientific advisory board including leadership from the Syneos Health Epidemiology Team to evaluate all reported pregnancy data
Helping develop the medicines people need is something we take personally.
Helping develop the medicines people need is something we take personally.
