Schrijver, Lieske H., Antoniou, Antonis C., Olsson, Hakan ORCID: 0000-0002-8794-9635, Mooij, Thea M., Roos-Blom, Marie-Jose, Azarang, Leyla, Adlard, Julian, Ahmed, Munaza, Barrowdale, Daniel, Davidson, Rosemarie, Donaldson, Alan, Eeles, Ros, Evans, D. Gareth, Frost, Debra, Henderson, Alex, Izatt, Louise, Ong, Kai-Ren, Bonadona, Valerie, Coupier, Isabelle, Faivre, Laurence, Fricker, Jean-Pierre, Gesta, Paul, van Engelen, Klaartje, Jager, Agnes, Menko, Fred H., Mourits, Marian J. E., Singer, Christian F., Tan, Yen Y., Foretova, Lenka ORCID: 0000-0003-0494-2620, Navratilova, Marie, Schmutzler, Rita K., Ellberg, Carolina, Gerdes, Anne-Marie, Caldes, Trinidad, Simard, Jacques ORCID: 0000-0001-6906-3390, Olah, Edith, Jakubowska, Anna, Rantala, Johanna, Osorio, Ana ORCID: 0000-0001-8124-3984, Hopper, John L., Phillips, Kelly-Anne, Milne, Roger L., Terry, Mary Beth, Nogues, Catherine, Engel, Christoph ORCID: 0000-0002-7247-282X, Kast, Karin, Goldgar, David E., van Leeuwen, Flora E., Easton, Douglas F., Andrieu, Nadine and Rookus, Matti A. (2021). Oral contraceptive use and ovarian cancer risk for BRCA1/2 mutation carriers: an international cohort study. Am. J. Obstet. Gynecol., 225 (1). NEW YORK: MOSBY-ELSEVIER. ISSN 1097-6868

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Abstract

Obstetrical complications, often referred to as the great obstetrical syndromes, are among the most common global causes of mortality and morbidity in young women and their infants. However, treatments for these syndromes are underdeveloped compared with other fields of medicine and are urgently needed. This current paucity of treatments for obstetrical complications is a reflection of the challenges of drug development in pregnancy. The appetite of pharmaceutical companies to invest in research for obstetrical syndromes is generally reduced by concerns for maternal, fetal, and infant safety, poor definition, and high-risk regulatory paths toward product approval. Notably, drug candidates require large investments for development with an unguaranteed return on investment. Furthermore, the discovery of promising drug candidates is hampered by a poor understanding of the pathophysiology of obstetrical syndromes and their uniqueness to human pregnancies. This limits translational extrapolation and de-risking strategies in preclinical studies, as available for other medical areas, compounded with limited fetal safety monitoring to capture early prenatal adverse reactions. In addition, the ethical review committees are reluctant to approve the inclusion of pregnant women in trials, and in the absence of regulatory guidance in obstetrics, clinical development programs are subject to unpredictable regulatory paths. To develop effective and safe drugs for pregnancy complications, substantial commitment, and investment in research for innovative therapies are needed in parallel with the creation of an enabling ethical, legislative, and guidance framework. Solutions are proposed to enable stakeholders to work with a common set of expectations to facilitate progress in this medical discipline. Addressing this significant unmet need to advance maternal and possibly perinatal health requires the involvement of all stakeholders and specifically patients, couples, and cli-nicians facing pregnancy complications in the dearth of appropriate therapies. This paper focused on the key pharmaceutical research and development challenges to achieve effective and safe treatments for obstetrical syndromes.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Schrijver, Lieske H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Antoniou, Antonis C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Olsson, HakanUNSPECIFIEDorcid.org/0000-0002-8794-9635UNSPECIFIED
Mooij, Thea M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Roos-Blom, Marie-JoseUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Azarang, LeylaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Adlard, JulianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ahmed, MunazaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Barrowdale, DanielUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Davidson, RosemarieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Donaldson, AlanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eeles, RosUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Evans, D. GarethUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Frost, DebraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Henderson, AlexUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Izatt, LouiseUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ong, Kai-RenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bonadona, ValerieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Coupier, IsabelleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Faivre, LaurenceUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fricker, Jean-PierreUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gesta, PaulUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Engelen, KlaartjeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jager, AgnesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Menko, Fred H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mourits, Marian J. E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Singer, Christian F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tan, Yen Y.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Foretova, LenkaUNSPECIFIEDorcid.org/0000-0003-0494-2620UNSPECIFIED
Navratilova, MarieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmutzler, Rita K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ellberg, CarolinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gerdes, Anne-MarieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Caldes, TrinidadUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Simard, JacquesUNSPECIFIEDorcid.org/0000-0001-6906-3390UNSPECIFIED
Olah, EdithUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jakubowska, AnnaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rantala, JohannaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Osorio, AnaUNSPECIFIEDorcid.org/0000-0001-8124-3984UNSPECIFIED
Hopper, John L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Phillips, Kelly-AnneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Milne, Roger L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Terry, Mary BethUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nogues, CatherineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Engel, ChristophUNSPECIFIEDorcid.org/0000-0002-7247-282XUNSPECIFIED
Kast, KarinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goldgar, David E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Leeuwen, Flora E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Easton, Douglas F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Andrieu, NadineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rookus, Matti A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-608108
DOI: 10.1016/j.ajog.2021.01.014
Journal or Publication Title: Am. J. Obstet. Gynecol.
Volume: 225
Number: 1
Date: 2021
Publisher: MOSBY-ELSEVIER
Place of Publication: NEW YORK
ISSN: 1097-6868
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
HORMONAL FACTORS; SURVIVAL; WOMEN; BREASTMultiple languages
Obstetrics & GynecologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/60810

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