Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children's Pediatric Innovation Research Forum
| Autor: | Edward M. Connor, Robert M. Nelson, Christina Bucci-Rechtweg, Dionna J Green, Ronald J. Portman, Thomas Miller, Gary J. Noel, Carmen Moreno, Donna L. Snyder, Collin Hovinga |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
medicine.medical_specialty Adolescent Pharmacy Drug development Disease Analytical Report Adolescents 030226 pharmacology & pharmacy 01 natural sciences Pediatrics 010104 statistics & probability 03 medical and health sciences 0302 clinical medicine Clinical trials Intervention (counseling) Medicine Humans Pharmacology (medical) 0101 mathematics Child Pharmacology Toxicology and Pharmaceutics (miscellaneous) Clinical Trials as Topic business.industry Phase 3 trials Public Health Environmental and Occupational Health Clinical trial Family medicine business Inclusion (education) |
| Zdroj: | Therapeutic Innovation & Regulatory Science |
| ISSN: | 2168-4804 |
| Popis: | Including adolescents in adult clinical trials can play an important role in making innovative new medicines available to children in a timelier fashion. Stakeholders involved in the processes leading to regulatory approval and labeling of new drugs recognize that challenges exist in involving adolescents and older children in clinical trials before the safety and efficacy of these drugs are established for adults. However, it has been possible to design and execute phase 3 trials that combine adults with adolescents which are medically and scientifically sound and ethically justified. Based on this experience and considerations of the medical and scientific, ethical, and operation-related matters, the 2019 Pediatric Innovation Research Forum advocated for the position that adolescents routinely be considered for enrollment in phase 3 clinical trials. The Forum also concluded that exclusion of adolescents in adult pivotal trials occur only when a thorough evaluation of the target disease and the potential benefit and risks of the study intervention supports a delay in their involvement until after completion of clinical trials in adults. |
| Databáze: | OpenAIRE |
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