Recommendations to Enhance Pediatric Cardiovascular Drug Development: Report of a Multi‐Stakeholder Think Tank

Autor:	Prince J. Kannankeril, Robert E. Shaddy, Dianne Murphy, Rachel D. Torok, Patricia Furlong, Andrew M. Atz, D. Dunbar Ivy, Danshi Li, Gail D. Pearson, Brian W. McCrindle, Ronald J. Portman, Thomas G. Diacovo, Daphne T. Hsu, Michael G. Hanna, Miriam Pina, Brigitte Lebeaut, Lisa Percival, Cathy Chen, Christoph Male, Eric M. Graham, Lisa A. Kammerman, Kevin D. Hill, Ellen Bolotin, Raafat Bishai, Pierre Mugnier, Jane W. Newburger, Jennifer S. Li, Timothy F. Feltes, John H. Lawrence, Norman Stockbridge, Robert Temple, Vasum Peiris, Stefanie Breitenstein, Gregory L. Kearns
Rok vydání:	2018
Předmět:	Drug trial 030204 cardiovascular system & hematology outcomes Pediatrics 0302 clinical medicine Clinical Studies Medicine 030212 general & internal medicine Multi stakeholder Child Hypolipidemic Agents media_common Clinical Trials as Topic Quality and Outcomes Age Factors clinical trial regulation Statements and Guidelines Legislature Treatment Outcome Drug development Cardiovascular Diseases Child Preschool pediatric cardiology Cardiology and Cardiovascular Medicine Needs Assessment Drug medicine.medical_specialty Consensus Adolescent Endpoint Determination media_common.quotation_subject 03 medical and health sciences Drug Development Stakeholder Participation Humans media_common.cataloged_instance Cardiovascular drug European union Special Report Antihypertensive Agents business.industry Patient Selection Infant Newborn Infant Cardiovascular Agents Clinical trial Family medicine Ethics and Policy business
Zdroj:	Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
ISSN:	2047-9980
Popis:	Children have historically been underrepresented or, indeed, omitted entirely, in drug trials, leading to a relative dearth of evidence in support of appropriate drug treatments for many pediatric diseases.[1][1], [2][2] Recent legislative initiatives in the United States and the European Union (EU
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0cd2ba6e4ae71988837823ea2c2a6926 https://doi.org/10.1161/jaha.117.007283 Zobrazit plný text záznamu Plný text