August 13, 2019

A Seven Year Registry

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Content 

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

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

To compare maternal, fetal and infant outcomes in women exposed to immuno-modulator treatment with the outcomes of unexposed external comparison groups.

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
  • 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

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