Direct-to-Patient Research: Piloting a New Approach to Understanding Drug Safety During Pregnancy

Nancy A Dreyer   ¹ , P.hD,MPH ;   Stella CF Blackburn   ² , M.B,BS,M.A.,M.Sc ;   Shahrul Mt-Isa   ³ , B Sc,P.hD ;   Jonathan L Richardson   ^{4, 5} , B BSc (Hons) ;   Simon Thomas   ^{4, 5} , B Sc,M.D.,FRCP ;   Maja Laursen   ⁶ , Ph. D.,M. Sc. ;   Priscilla Zetstra-van der Woude   ⁷ , M Sc ;   Anna Jamry-Dziurla   ⁸ , M Sc ;   Valerie Hliva   ⁹ , Ph. D. ;   Alison Bourke   ¹⁰ , B Sc,M Sc ;   Lolkje de Jong-van den Berg   ⁷ , Ph. D.,PharmD

¹ Quintiles Real-World & Late Phase Research, Cambridge, MA, United States

² Quintiles Real-World & Late Phase Research, Reading, United Kingdom

³ Imperial College, London, United Kingdom

⁴ Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom

⁵ UK Teratology Information Service, Newcastle Hospitals, NHS Foundation Trust, Newcastle upon Tyne, United Kingdom

⁶ Statens Serum Institut, Copenhagen, Denmark

⁷ University of Groningen, Groningen, Netherlands

⁸ Poznan University of Medical Sciences, Poznan, Poland

⁹ Quintiles Real-World & Late-Phase Research, St. Prex, Switzerland

¹⁰ IMS, London, United Kingdom