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Abstract
Clinical trials in children are essential for generating reliable data on new medicines and treatment methods. Without such studies, children may be subjected to ineffective or harmful treatments. The aim of this review is to examine the current state of clinical trials in pediatric medicine. This review article is based on literature from PubMed, Google Scholar, and other reputable sources. A child is legally defined as a person under 18 years old, and children constitute nearly one-third of the world’s population. However, due to limited clinical data specific to pediatric patients, physicians often rely on adult patient data when prescribing treatments for children. This practice can be problematic, as children exhibit a unique spectrum of diseases and their drug metabolism differs significantly from that of adults. Consequently, the effects of medications in children can be unpredictable. This review highlights the importance of conducting clinical trials tailored to pediatric populations to ensure safe and effective treatment strategies.
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References
- جهانآبادی، موسوی، ع. س. طبیبی، ز.؛ مهرام، ب.؛ و مدرس غروی، م. (1397). الزامات و چالشهای اجرایی و اخلاقی پژوهش با کودک: ارائه نمونه الگویی مشارکتی برای پژوهش در حوزه جنسیت. مجله پژوهش در حوزه جنسیت، ایران (1) 6، 9.
- حسینی سادات، ا.ا. (1391). نقدی بر راهنمای اخلاق کشور در پژوهش بر روی کودکان. مجله ایرانی اخلاق و تاریخ پزشکی، 5(4)، 2-21.
- صادقی، ز. و پارسا، م. (1401). چالشهای اخلاقی مراقبت از کودکان و نوجوانان از دیدگاه متخصصین اطفال. مجله اخلاق پزشکی، 16(47)، 3-16.
- Ad hoc group for the development of implementing guidelines for Directive 2001/20/EC. (2008). Ethical considerations for clinical trials on medicinal products with the paediatric population. Recommendations of the Ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use.
- Ali, K., Berman, G., Zhou, H., Deng, W., Faughnan, V., Coronado-Voges, M., Ding, B., & McPhee, R. (2021, August 11). Evaluation of mRNA-1273 SARS-CoV-2 vaccine in adolescents. New England Journal of Medicine, 385(24), 2241–2251. https://doi.org/10.1056/NEJMoa2109522
- Centers for Disease Control and Prevention. (n.d.). COVID-19 vaccines for children and teens. Retrieved February 7, 2022, from https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/children-teens.html
- Claire, C. (2019). Clinical trials involving children and young people. British Journal of Nursing. https://doi.org/10.12968/BJON.2019.28.21.1370
- Euronews. (2021, October 22). United States: Euronews. Retrieved October 26, 2023, from https://parsi.euronews.com/2021/10/22/pfizer-biontec-vaccine-provides-more-than-90-immunity-in-children
- European Centre for Disease Prevention and Control. (n.d.). COVID-19. Retrieved March 6, 2022, from https://qap.ecdc.europa.eu/public/extensions/COVID-19/COVID-19.html
- European Clinical Research Infrastructure Network. (n.d.). Chapter 8: Ethical considerations in clinical trials. European Clinical Research Infrastructure Network. Retrieved February 25, 2025, from https://ecrin.org/sites/default/files/Ecrin/pdf/Chapter8.pdf
- Frenck, R. W., Jr, Klein, N. P., Kitchin, N., Gurtman, A., Absalon, J., Lockhart, S., Perez, J. L., Walter, E. B., Senders, S., Bailey, R., Swanson, K. A., Ma, H., Xu, X., Koury, K., Kalina, W. V., Cooper, D., Jennings, T., Brandon, D. M., Thomas, S. J., Türeci, Ö., … C4591001 Clinical Trial Group (2021). Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. The New England journal of medicine, 385(3), 239–250. https://doi.org/10.1056/NEJMoa2107456
- Government of Canada. (n.d.). Coronavirus disease 2019 (COVID-19): Epidemiology update. Retrieved March 6, 2022, from https://health-infobase.canada.ca/covid-19/epidemiological-summary-covid-19-cases.html
- Government of Pakistan. (n.d.). Pakistan cases details. Retrieved March 6, 2022, from http://covid.gov.pk/stats/pakistan
- Hamshahri Online. (2020, January 13). Organization. Hamshahri Online. Retrieved September 26, 2023, from https://hamshahrionline.ir/xDnF
- Julia, D., Dianne, M., & William, J. R. (2012). The globalization of pediatric clinical trials. Pediatrics, 130(6), 3.
- Keyvanlab. (2023). Corona vaccine in children. Virotopia. Retrieved October 10, 2023, from https://keyvanlab.com/blog/corona-vaccine-in-children
- Koodaknews. (2019, September 29). UNICEF: Shakila Fayeq. Retrieved July 26, 2023, from https://koodaknews.af/1397/07/07/who-is-child-and-what-is-thier-right
- Lymphoma Australia. (n.d.). Understanding clinical trials. Lymphoma Australia. Retrieved February 23, 2025, from https://www.lymphoma.org.au/lymphoma/understanding-clinical-trials/
- P, A., Dhar, R., & Krishnappa, N. (2022). Clinical trials in pediatrics—review of ethics and law. International Journal of Basic & Clinical Pharmacology, 11(5), 538–544. https://doi.org/10.18203/2319-2003.ijbcp20222155
- Pathma, D. J., Jonathan, C., & Patrina, H. Y. (2013). Clinical trials in children. British Journal of Clinical Pharmacology, 79(3).
- Patrina, H., Sharon, B., Phyllis, N., & Jonathan, C. (2004). Clinical trials in children. The Lancet, 803–811.
- Pavithra, V., Devendra, M., Shatrishna, B., & Monica, J. (2020). Paracetamol versus ibuprofen for the acute treatment of migraine headache in children: A blinded randomized controlled trial. Indian Journal of Pediatrics, 1–4.
- Podany, A. T. (2017). Ethical considerations in pediatric research. PedSAP, 9.
- Sammons, H. (2009). Ethical issues of clinical trials in children: A European perspective. European Journal of Pediatrics, 94(10), 1–4.
- The Novel Coronavirus Pneumonia Emergency Response Epidemiology Team. (2020). The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19)—China, 2020. China CDC Weekly, 2, 113–122.
- Walter, E. B., Talaat, K. R., Sabharwal, C., Gurtman, A., Lockhart, S., Paulsen, G. C., Barnett, E. D., Muñoz, F. M., Maldonado, Y., Pahud, B. A., Domachowske, J. B., Simões, E. A. F., Sarwar, U. N., Kitchin, N., Cunliffe, L., Rojo, P., Kuchar, E., Rämet, M., Munjal, I., Perez, J. L., … C4591007 Clinical Trial Group (2022). Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. The New England journal of medicine, 386(1), 35–46. https://doi.org/10.1056/NEJMoa2116298
- World Health Organization. (2010, October). International clinical trials registry platform. Retrieved July 27, 2023, from https://who.int
- World Health Organization. (n.d.). Coronavirus disease COVID-19. WHO COVID-19 Dashboard. Retrieved February 7, 2022, from https://covid19.who.int
- World Health Organization. (n.d.). Clinical trials in children. World Health Organization. Retrieved February 25, 2025, from https://www.who.int/clinical-trials-registry-platform/clinical-trials-in-children
- Yang, Z., Xingyu, Z., Litum, Z., Li, I., & Tao, Z. (2008–2009). Updated analysis of pediatric clinical studies registered in clinical trials. BMC Pediatrics, 21, 212.
References
جهانآبادی، موسوی، ع. س. طبیبی، ز.؛ مهرام، ب.؛ و مدرس غروی، م. (1397). الزامات و چالشهای اجرایی و اخلاقی پژوهش با کودک: ارائه نمونه الگویی مشارکتی برای پژوهش در حوزه جنسیت. مجله پژوهش در حوزه جنسیت، ایران (1) 6، 9.
حسینی سادات، ا.ا. (1391). نقدی بر راهنمای اخلاق کشور در پژوهش بر روی کودکان. مجله ایرانی اخلاق و تاریخ پزشکی، 5(4)، 2-21.
صادقی، ز. و پارسا، م. (1401). چالشهای اخلاقی مراقبت از کودکان و نوجوانان از دیدگاه متخصصین اطفال. مجله اخلاق پزشکی، 16(47)، 3-16.
Ad hoc group for the development of implementing guidelines for Directive 2001/20/EC. (2008). Ethical considerations for clinical trials on medicinal products with the paediatric population. Recommendations of the Ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use.
Ali, K., Berman, G., Zhou, H., Deng, W., Faughnan, V., Coronado-Voges, M., Ding, B., & McPhee, R. (2021, August 11). Evaluation of mRNA-1273 SARS-CoV-2 vaccine in adolescents. New England Journal of Medicine, 385(24), 2241–2251. https://doi.org/10.1056/NEJMoa2109522
Centers for Disease Control and Prevention. (n.d.). COVID-19 vaccines for children and teens. Retrieved February 7, 2022, from https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/children-teens.html
Claire, C. (2019). Clinical trials involving children and young people. British Journal of Nursing. https://doi.org/10.12968/BJON.2019.28.21.1370
Euronews. (2021, October 22). United States: Euronews. Retrieved October 26, 2023, from https://parsi.euronews.com/2021/10/22/pfizer-biontec-vaccine-provides-more-than-90-immunity-in-children
European Centre for Disease Prevention and Control. (n.d.). COVID-19. Retrieved March 6, 2022, from https://qap.ecdc.europa.eu/public/extensions/COVID-19/COVID-19.html
European Clinical Research Infrastructure Network. (n.d.). Chapter 8: Ethical considerations in clinical trials. European Clinical Research Infrastructure Network. Retrieved February 25, 2025, from https://ecrin.org/sites/default/files/Ecrin/pdf/Chapter8.pdf
Frenck, R. W., Jr, Klein, N. P., Kitchin, N., Gurtman, A., Absalon, J., Lockhart, S., Perez, J. L., Walter, E. B., Senders, S., Bailey, R., Swanson, K. A., Ma, H., Xu, X., Koury, K., Kalina, W. V., Cooper, D., Jennings, T., Brandon, D. M., Thomas, S. J., Türeci, Ö., … C4591001 Clinical Trial Group (2021). Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. The New England journal of medicine, 385(3), 239–250. https://doi.org/10.1056/NEJMoa2107456
Government of Canada. (n.d.). Coronavirus disease 2019 (COVID-19): Epidemiology update. Retrieved March 6, 2022, from https://health-infobase.canada.ca/covid-19/epidemiological-summary-covid-19-cases.html
Government of Pakistan. (n.d.). Pakistan cases details. Retrieved March 6, 2022, from http://covid.gov.pk/stats/pakistan
Hamshahri Online. (2020, January 13). Organization. Hamshahri Online. Retrieved September 26, 2023, from https://hamshahrionline.ir/xDnF
Julia, D., Dianne, M., & William, J. R. (2012). The globalization of pediatric clinical trials. Pediatrics, 130(6), 3.
Keyvanlab. (2023). Corona vaccine in children. Virotopia. Retrieved October 10, 2023, from https://keyvanlab.com/blog/corona-vaccine-in-children
Koodaknews. (2019, September 29). UNICEF: Shakila Fayeq. Retrieved July 26, 2023, from https://koodaknews.af/1397/07/07/who-is-child-and-what-is-thier-right
Lymphoma Australia. (n.d.). Understanding clinical trials. Lymphoma Australia. Retrieved February 23, 2025, from https://www.lymphoma.org.au/lymphoma/understanding-clinical-trials/
P, A., Dhar, R., & Krishnappa, N. (2022). Clinical trials in pediatrics—review of ethics and law. International Journal of Basic & Clinical Pharmacology, 11(5), 538–544. https://doi.org/10.18203/2319-2003.ijbcp20222155
Pathma, D. J., Jonathan, C., & Patrina, H. Y. (2013). Clinical trials in children. British Journal of Clinical Pharmacology, 79(3).
Patrina, H., Sharon, B., Phyllis, N., & Jonathan, C. (2004). Clinical trials in children. The Lancet, 803–811.
Pavithra, V., Devendra, M., Shatrishna, B., & Monica, J. (2020). Paracetamol versus ibuprofen for the acute treatment of migraine headache in children: A blinded randomized controlled trial. Indian Journal of Pediatrics, 1–4.
Podany, A. T. (2017). Ethical considerations in pediatric research. PedSAP, 9.
Sammons, H. (2009). Ethical issues of clinical trials in children: A European perspective. European Journal of Pediatrics, 94(10), 1–4.
The Novel Coronavirus Pneumonia Emergency Response Epidemiology Team. (2020). The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19)—China, 2020. China CDC Weekly, 2, 113–122.
Walter, E. B., Talaat, K. R., Sabharwal, C., Gurtman, A., Lockhart, S., Paulsen, G. C., Barnett, E. D., Muñoz, F. M., Maldonado, Y., Pahud, B. A., Domachowske, J. B., Simões, E. A. F., Sarwar, U. N., Kitchin, N., Cunliffe, L., Rojo, P., Kuchar, E., Rämet, M., Munjal, I., Perez, J. L., … C4591007 Clinical Trial Group (2022). Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. The New England journal of medicine, 386(1), 35–46. https://doi.org/10.1056/NEJMoa2116298
World Health Organization. (2010, October). International clinical trials registry platform. Retrieved July 27, 2023, from https://who.int
World Health Organization. (n.d.). Coronavirus disease COVID-19. WHO COVID-19 Dashboard. Retrieved February 7, 2022, from https://covid19.who.int
World Health Organization. (n.d.). Clinical trials in children. World Health Organization. Retrieved February 25, 2025, from https://www.who.int/clinical-trials-registry-platform/clinical-trials-in-children
Yang, Z., Xingyu, Z., Litum, Z., Li, I., & Tao, Z. (2008–2009). Updated analysis of pediatric clinical studies registered in clinical trials. BMC Pediatrics, 21, 212.