2023 / 02

DOI: 10.24075/medet.2023.016

ОБЗОР

Этические проблемы при изучении лекарственных средств в педиатрии

А. С. Колбин1,2, Л. И. Емельянова1
Информация об авторах

1 Первый Санкт-Петербургский государственный медицинский университет имени академика И. П. Павлова, Санкт-Петербург, Россия

2 Санкт-Петербургский государственный университет, Санкт-Петербург, Россия

Для корреспонденции: Алексей Сергеевич Колбин
ул. Льва Толстого, д. 6–8, г. Санкт-Петербург, 197022, Россия; аur.liam@niblok.xel

Информация о статье

Вклад авторов: Л. И. Емельянова — обзор литературы, написание статьи; А. С. Колбин — редактирование статьи.

Статья получена: 29.05.2023 Статья принята к печати: 21.06.2023 Опубликовано online: 28.06.2023
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  1. Turner S, Longworth A, Nunn AJ, et al. Unlicensed and off label drug use in paediatric wards: prospective study. British Medical Journal. 1998; 316(7128): 343–5.
  2. Колбин А. С., Зырянов С. К., Белоусов Д. Ю. Фармаконадзор. Москва: ОКИ Буки Веди. 2019; 248 с.
  3. Saunders H, Wright R, Hodgkin K. Thalidomide and congenital deformities. British Medical Journal. 1962; 2(5307): 796.
  4. Колбин А. С. Клиническая фармакология для педиатров: учебное пособие. Москва: ГЭОТАР-Медиа. 2020; 288 с.
  5. Shirkey H. Editorial comment: therapeutic orphans. Journal of Pediatrics. 1968; 72: 119–120.
  6. Cohen-Wolkowiez M, Benjamin DK. Development of Therapeutics for Children — A Tricky Balancing Act. JAMA Pediatrics. 2019; 173(1): 18–19.
  7. Green DJ, Sun H, Burnham J, et al. Surrogate Endpoints in Pediatric Studies Submitted to the US FDA. Clinical Pharmacology & Therapeutics. 2019; 105(3): 555–557.
  8. Rieder M, Hawcutt D. Design and conduct of early phase drug studies in children: challenges and opportunities. British Journal of Clinical Pharmacology. 2016; 82(5): 1308–1314.
  9. Yellepeddi VK, Roberts JK, Escobar L, et al. ADME Processes in Pharmaceutical Sciences. Publisher: Springer Cham. 2018; 203–222.
  10. Burckart GJ, van den Anker JN. Neonatal and Pediatric Dose Selection: Quo Vadis? Journal of Clinical Pharmacology. 2021; 61: 7–8.
  11. US National Library of Medicine. Database of privately and publicly funded clinical studies. Режим доступа: [Электронный ресурс]. URL: https://clinicaltrials.gov. Дата обращения: 05.05.2023.
  12. US Food and Drug Administration. New pediatric labeling information database. Режим доступа: [Электронный ресурс]. URL: https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=labelingdatabase. Дата обращения: 05.05.2023.
  13. Powell JR, Cook J, Wang Y, et al. Drug Dosing Recommendations for All Patients: A Roadmap for Change. Clinical Pharmacology & Therapeutics. 2021; 109(1): 65–72.
  14. Гармонизированное трехстороннее руководство ICH. Указания по доклиническим исследованиям безопасности в целях проведения клинических исследований на человеке и регистрации лекарств M3 (R2). Текущая версия (этап 4) от 11 июня 2009 г. Библиотека нормативно-правовых актов. Режим доступа: [Электронный ресурс] URL: http://pharmadvisor. ru/documents/tr3528/tr3528.html#[6,%22XYZ%22,82,714, null] Дата обращения: 05.05.2023.
  15. Burt T, Noveck R, MacLeod D, et al. Intra-target microdosing (ITM): a novel drug development approach aimed at enabling safer and earlier translation of biological insights into human testing. Clinical and Translational Science. 2017; 10(5): 337–350.
  16. Turner M, Mooij M, Vaes W, et al. Pediatric microdose and microtracer studies using 14C in Europe. Clinical Pharmacology & Therapeutics. 2015; 98(3): 234–237.
  17. U. S. Department of Health and Human Services, Food and Drug Administration, 21st Century Cures Act FDA, 2018. Режим доступа: [Электронный ресурс]. URL: https://www.fda.gov/ Drugs. Дата обращения: 05.05.2023.
  18. U. S. Department of Health and Human Services, Food and Drug Administration, Advisory Committees. Режим доступа: [Электронный ресурс]. URL: www.fda.gov/advisory-committees. Дата обращения: 05.05.2023.
  19. Roth-Cline M, Nelson R. Microdosing studies in children: a US regulatory perspective. Clinical Pharmacology & Therapeutics. 2015; 98(3): 232–233.
  20. Mooij MG, van Duij E, Knibbe CAJ, et al. Successful use of [14C] Paracetamol microdosing to elucidate developmental changes in drug metabolism. Clinical Pharmacokinetics. 2017; 56(10): 1185–1195.
  21. Germovsek E, Barker CIS, Sharland M, et al. Pharmacokinetic-pharmacodynamic modeling in pediatric drug development, and the Importance of standardized scaling of clearance. Clinical Pharmacokinetics. 2019; 58(1): 39–52.
  22. Chitty KM, Chan B, Pulanco CL, et al. Discontinuities and disruptions in drug dosage guidelines for the pediatric population. British Journal of Clinical Pharmacology. 2018; 84 (5): 1029–1037.
  23. Rieder M, Carleton B. Pharmacogenomics and adverse drug reactions in children. Frontiers in Genetics. 2014; 5: 78.
  24. U. S. Department of Health and Human Services, Food and Drug Administration, Informed Consent Information Sheet, Guidance for IRBs, Clinical Investigators, and Sponsors, DRAFT GUIDANCE. July 2014. Режим доступа: [Электронный ресурс]. URL: https://www.fda.gov/files/about%20fda/published/Informed-Consent-Information-Sheet-%28Printer-Friendly%29.pdf. Дата обращения: 05.05.2023.
  25. U. S. Department of Health and Human Services, Food and Drug Administration, Ethical Considerations for Clinical Investigations of Medical Products Involving Children Guidance for Industry, Sponsors, and IRBs; DRAFT GUIDANCE. September 2022. Режим доступа: [Электронный ресурс]. URL: https://www. fda.gov/regulatory-information/search-fda-guidance-documents/ ethical-considerations-clinical-investigations-medical-productsinvolving-children. Дата обращения: 05.05.2023.
  26. U. S. Department of Health and Human Services, Food and Drug Administration, International Collaboration / Pediatric Cluster. Режим доступа: [Электронный ресурс]. URL: https://www.fda.gov/science-research/pediatrics/international-collaboration-pediatric-cluster. Дата обращения: 05.05.2023.
  27. Nicolas JM, Bouzom F, Hugues C. Oral drug absorption in pediatrics: the intestinal wall, its developmental changes and current tools for predictions. Biopharmaceutics & Drug Disposition. 2017; 38(3): 209–230.
  28. Ollivier C, Mulugeta YL, Ruggieri L, et al. Paediatric extrapolation: a necessary paradigm shift. British Journal of Clinical Pharmacology. 2019; 85(4): 675–679.
  29. Wang J, Avant D, Green D, et al. A survey of neonatal pharmacokinetic and pharmacodynamic studies in pediatric drug development. Clinical Pharmacology & Therapeutics. 2015; 98 (3): 328–335.
  30. ICH E11. Available from URL: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Effi cacy/E11/Step4/ E11_Guideline.pdf. Дата обращения: 05.05.2023.
  31. U. S. Department of Health and Human Services, Food and Drug Administration, General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products, Guidance for Industry. July 2022. Режим доступа: [Электронный ресурс]. URL: https://www.fda.gov/regulatory-information/ search-fda-guidance-documents/general-clinical-pharmacologyconsiderations-neonatal-studies-drugs-and-biological-productsguidance. Дата обращения: 05.05.2023.
  32. US Food and Drug Administration. Medical Products for Newborns. Режим доступа: [Электронный ресурс]. URL: https://www.fda.gov/science-research/pediatrics/medicalproducts-newborns. Дата обращения: 14.05.2023.
  33. Momper J, Mulugeta Y, Burckart G. Failed pediatric drug development trials. Clinical Pharmacology & Therapeutics. 2015; 98 (3): 245–251.
  34. Weimer K, Gulewitsch MD, Schlarb AA. Placebo eff ects in children: a review. Pediatric Research. 2013; 74(1): 96–102.
  35. Simoens S, Cassiman D, Dooms M, et al. Orphan drugs for rare diseases: is it time to revisit their special market access status? Drugs. 2012; 72(11): 1437–1443.
  36. Об основах охраны здоровья граждан в Российской Федерации. Федеральный закон от 21.11.2011 № 323-ФЗ. Сайт Справочно-правовой системы «Гарант». Режим доступа: [Электронный ресурс]. URL: https://base.garant.ru/12191967/ Дата обращения: 05.05.2023.
  37. Arnold RJ, Bighash L, Bryon Nieto A, et al. The role of globalization in drug development and access to orphan drugs: orphan drug legislation in the US/EU and in Latin America. F1000Res. 2015; 4: 57.
  38. Bhattacharya I, Manukyan Z, Chan P. Making every subject count: a case study of drug development path for medication in a pediatric rare disease. Clinical Pharmacology & Therapeutics. 2016; 100(4): 330–332.