2023 / 03

DOI: 10.24075/medet.2023.025

МНЕНИЕ

Клинические исследования у беременных: проблемы и решения

К. А. Луцевич, И. Г. Рыженкова, О. В. Решетько
Информация об авторах

Саратовский государственный медицинский университет им. В. И. Разумовского, Саратов, Россия

Для корреспонденции: Ольга Вилоровна Решетько
ул. Б. Казачья, д.112, г. Саратов, Россия, 410012; ur.xednay@oktehser

Информация о статье

Вклад авторов: К. А. Луцевич — подбор литературы, написание статьи; И. Г. Рыженкова — подбор и анализ литературы; О. В. Решетько — анализ литературы, обобщение материала, написание статьи.

Статья получена: 21.06.2023 Статья принята к печати: 18.09.2023 Опубликовано online: 10.10.2023
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  1. General Accounting Office. FDA needs to ensure more study of gender differences in prescription drug testing. 1992 Oct 29. GAO/HRD‑93‑17.
  2. U. S. Food and Drug Administration. Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs; notice. Fed Regist. 1993; 58 (139): 39406–39416.
  3. General Accounting Office. Most drugs withdrawn in recent years had greater health risks for women. 2001 Jan 19. GAO‑01‑286R.
  4. Catriona Waitt, Denise Astill, Eleonor Zavala et al. Clinical trials and pregnancy. COMMUNICATIONS MEDICINE | (2022) 2: 132.
  5. Adam MP, Polifka JE, Friedman JM. Evolving knowledge of the teratogenicity of medications in human pregnancy. Am J Med Genet C Semin Med Genet. 2011; 157c (3): 175–82.
  6. Knight M, Bunch K, Tuffnell D, et al., editors. Saving Lives, Improving Mothers’ Care — Lessons learned to inform maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2017‑19. Oxford: National Perinatal Epidemiology Unit, University of Oxford. 2021.
  7. Stock SJE, Norman JE. Medicines in pregnancy. 2019 Jun 20; 8: F1000 Faculty Rev‑911.
  8. Lyerly AD, Little MO, Faden R. The second wave: Toward responsible inclusion of pregnant women in research. Int J Fem Approaches Bioeth. 2008 Fall; 1(2): 5–22.
  9. Macklin R. The art of medicine: Enrolling pregnant women in biomedical research. The Lancet. 2010 February 20; 375: 632–3.
  10. The Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). Guideline 17.
  11. Demirtas MS. The Pathogenesis of Congenital Anomalies: Roles of Teratogens and Infections. Congenital Anomalies in Newborn Infants — Clinical and Etiopatological Perspectives. 2020.
  12. American College of Obstetricians and Gynecologists. Committee Opinion no. 646: Ethical considerations for including women as research participants. Obstet Gynecol. 2015; 126: e100–7.
  13. ФЗ «Об обращении лекарственных средств» № 61‑ФЗ от 12.04.2010 (ред. от 28.04.2023).
  14. U. S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials. Washington: US Food and Drug Administration. 2018.
  15. Lyerly AD, Beigi R, Bekker L‑G, et al. Ending the evidence gap for pregnancy, HIV and co‑infections: ethics guidance from the PHASES project. Journal of the International AIDS Society. 2021; 24 (12): e25846.
  16. Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States. Rockville, MD: Office of AIDS Research, National Institutes of Health. 2022; 20. Task force on research specific to pregnant women and lactating women.
  17. Vousden N, Haynes R, Findlay S et al. Facilitating participation in clinical trials during pregnancy. BMJ. 2023; 380: e071278
  18. Birmingham Health Partners Policy Commission. Healthy Mum, Healthy Baby, Healthy Future: The Case for UK Leadership in the Development of Safe, Effective and Accessible Medicines for Use in Pregnancy. Birmingham: University of Birmingham, 2022. Task force on research specific to pregnant women and lactating women. Report to Secretary, Health and Human Services, Congress. Rockville, Maryland: NICHD. 2018.
  19. Chappell LC, David AL. Improving the Pipeline for Developing and Testing Pharmacological Treatments in Pregnancy. PLOS Medicine. 2016; 13 (11): e1002161.
  20. Этическая экспертиза биомедицинских исследований: практические рекомендации (третье издание, исправленное и дополненное) под общей редакцией А. Л. Хохлова. Издательство ОКИ. 2021; 792 с.
  21. Решетько О. В., Луцевич К. А. Здоровье женщины во время беременности. Клиническая фармакология. ГЭОТАР‑Медиа. 2022; 200 с.