Unanswered Questions in Pediatric Clinical Trials: Literature Review
This literature review provides information on the deficit of clinically proven data on the drugs use in pediatric practice. Issues on why children are widely administrated with drugs that are normally intended for use in adults without any prior qualitative estimation of their safety and efficacy i...
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| Format: | Article |
| Language: | Russian |
| Published: |
Union of pediatricians of Russia
2022-03-01
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| Series: | Педиатрическая фармакология |
| Subjects: | |
| Online Access: | https://www.pedpharma.ru/jour/article/view/2131 |
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| _version_ | 1849243752732819456 |
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| author | Leyla S. Namazova-Baranova Nilab Sadeqi Alexander A. Baranov |
| author_facet | Leyla S. Namazova-Baranova Nilab Sadeqi Alexander A. Baranov |
| author_sort | Leyla S. Namazova-Baranova |
| collection | DOAJ |
| description | This literature review provides information on the deficit of clinically proven data on the drugs use in pediatric practice. Issues on why children are widely administrated with drugs that are normally intended for use in adults without any prior qualitative estimation of their safety and efficacy in appropriate clinical studies involving children have been analyzed. The authors considered the issues of carrying out clinical trials with the participation of children as study subjects: ethical, regulatory, and psychological aspects of this complex task. There are decisions for every of the listed aspect. The authors of analyzed sources and the authors of this article believe that these decisions may help to address all the challenges and evade the incorrect assessment and interpretation of initial data by children’s parents and adoptive parents (legal representatives). Issues of doctors’ alertness were considered separately. Information and excerpts from regulatory acts were given, as well as information from publications on awareness raising and in support of doctors-researches. This literature review has been carried out to solve problems of information gap in the field of drugs safety and efficacy in pediatric practice. The disclosure of discussion points for clinical trials with children will ultimately help to improve the quality of healthcare provided to children in the future and take advantage of recent technologies used in patients’ cohorts of other age groups. |
| format | Article |
| id | doaj-art-a2f680fd0a5d45458ef8462c8560d792 |
| institution | Kabale University |
| issn | 1727-5776 2500-3089 |
| language | Russian |
| publishDate | 2022-03-01 |
| publisher | Union of pediatricians of Russia |
| record_format | Article |
| series | Педиатрическая фармакология |
| spelling | doaj-art-a2f680fd0a5d45458ef8462c8560d7922025-08-20T03:59:21ZrusUnion of pediatricians of RussiaПедиатрическая фармакология1727-57762500-30892022-03-01191617110.15690/10.15690/pf.v19i1.23751877Unanswered Questions in Pediatric Clinical Trials: Literature ReviewLeyla S. Namazova-Baranova0Nilab Sadeqi1Alexander A. Baranov2Pirogov Russian National Research Medical University; Research Institute of Pediatrics and Children’s Health in Central Clinical Hospital of the Russian Academy of Sciences; Belgorod National Research UniversityResearch Institute of Pediatrics and Children’s Health in Central Clinical Hospital of the Russian Academy of SciencesResearch Institute of Pediatrics and Children’s Health in Central Clinical Hospital of the Russian Academy of Sciences; Sechenov First Moscow State Medical UniversityThis literature review provides information on the deficit of clinically proven data on the drugs use in pediatric practice. Issues on why children are widely administrated with drugs that are normally intended for use in adults without any prior qualitative estimation of their safety and efficacy in appropriate clinical studies involving children have been analyzed. The authors considered the issues of carrying out clinical trials with the participation of children as study subjects: ethical, regulatory, and psychological aspects of this complex task. There are decisions for every of the listed aspect. The authors of analyzed sources and the authors of this article believe that these decisions may help to address all the challenges and evade the incorrect assessment and interpretation of initial data by children’s parents and adoptive parents (legal representatives). Issues of doctors’ alertness were considered separately. Information and excerpts from regulatory acts were given, as well as information from publications on awareness raising and in support of doctors-researches. This literature review has been carried out to solve problems of information gap in the field of drugs safety and efficacy in pediatric practice. The disclosure of discussion points for clinical trials with children will ultimately help to improve the quality of healthcare provided to children in the future and take advantage of recent technologies used in patients’ cohorts of other age groups.https://www.pedpharma.ru/jour/article/view/2131clinical trialschildrenpsychologic aspectsoff-labelpediatric drugs |
| spellingShingle | Leyla S. Namazova-Baranova Nilab Sadeqi Alexander A. Baranov Unanswered Questions in Pediatric Clinical Trials: Literature Review Педиатрическая фармакология clinical trials children psychologic aspects off-label pediatric drugs |
| title | Unanswered Questions in Pediatric Clinical Trials: Literature Review |
| title_full | Unanswered Questions in Pediatric Clinical Trials: Literature Review |
| title_fullStr | Unanswered Questions in Pediatric Clinical Trials: Literature Review |
| title_full_unstemmed | Unanswered Questions in Pediatric Clinical Trials: Literature Review |
| title_short | Unanswered Questions in Pediatric Clinical Trials: Literature Review |
| title_sort | unanswered questions in pediatric clinical trials literature review |
| topic | clinical trials children psychologic aspects off-label pediatric drugs |
| url | https://www.pedpharma.ru/jour/article/view/2131 |
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