Improving Development of Drug Treatments for Pregnant Women and the Fetus

Authors

Anna L. David, Elizabeth Garrett Anderson Institute for Women's Health, University College London, 74 Huntley Street, London, UK. a.david@ucl.ac.uk.
Homa Ahmadzia, Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The George Washington University, Washington, DC, USA.
Richard Ashcroft, City University, London, UK.
Christina Bucci-Rechtweg, Head, Pediatric and Maternal Health Policy, Global Drug Development Regulatory Affairs, Pediatric Center of Excellence, Novartis Pharmaceuticals Corporation, Basel, Switzerland.
Rebecca N. Spencer, Elizabeth Garrett Anderson Institute for Women's Health, University College London, 74 Huntley Street, London, UK.
Steve Thornton, Queen Mary University of London, Dean Rees House, 2nd Floor, Charterhouse Square, London, EC1M 6BQ, UK.

Document Type

Journal Article

Publication Date

7-25-2022

Journal

Therapeutic innovation & regulatory science

DOI

10.1007/s43441-022-00433-w

Keywords

Adverse event; Fetus; Pregnancy clinical trial; Safety; Therapeutics

Abstract

The exclusion of pregnant populations, women of reproductive age, and the fetus from clinical trials of therapeutics is a major global public health issue. It is also a problem of inequity in medicines development, as pregnancy is a protected characteristic. The current regulatory requirements for drugs in pregnancy are being analyzed by a number of agencies worldwide. There has been considerable investment in developing expertise in pregnancy clinical trials (for the pregnant person and the fetus) such as the Obstetric-Fetal Pharmacology Research Centers funded by the National Institute of Child Health and Human Development. Progress has also been made in how to define and grade clinical trial safety in pregnant women, the fetus, and neonate. Innovative methods to model human pregnancy physiology and pharmacology using computer simulations are also gaining interest. Novel ways to assess fetal well-being and placental function using magnetic resonance imaging, computerized cardiotocography, serum circulating fetoplacental proteins, and mRNA may permit better assessment of the safety and efficacy of interventions in the mother and fetus. The core outcomes in women's and newborn health initiative is facilitating the consistent reporting of data from pregnancy trials. Electronic medical records integrated with pharmacy services should improve the strength of pharmacoepidemiologic and pharmacovigilance studies. Incentives such as investigational plans and orphan disease designation have been taken up for obstetric, fetal, and neonatal diseases. This review describes the progress that is being made to better understand the extent of the problem and to develop applicable solutions.

APA Citation

David, Anna L.; Ahmadzia, Homa; Ashcroft, Richard; Bucci-Rechtweg, Christina; Spencer, Rebecca N.; and Thornton, Steve, "Improving Development of Drug Treatments for Pregnant Women and the Fetus" (2022). GW Authored Works. Paper 1265.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/1265

Department

Obstetrics and Gynecology