Neonatal drug trials: Impact of EU and US paediatric regulations

Archives of Disease in Childhood: Fetal and Neonatal Edition

Volumn 99, Issue 5, 2014, Pages

  Pansieri, Claudia ^a,b   Bonati, Maurizio ^b   Choonara, Imti ^c   Jacqz Aigrain, Evelyne ^a,d  

^a HÔPITAL ROBERT DEBRÉ   (France)

^b MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

^c UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^d UNIVERSITÉ PARIS DESCARTES   (France)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO;

CARDIOVASCULAR SYSTEM; CLINICAL EVALUATION; COMPARATIVE STUDY; DRUG INDUSTRY; DRUG SCREENING; EVIDENCE BASED PRACTICE; HUMAN; LAW; LETTER; MULTICENTER STUDY (TOPIC); NERVOUS SYSTEM; NEWBORN; OFF LABEL DRUG USE; POPULATION; PRIMARY PREVENTION; PRIORITY JOURNAL; PROFIT; RANDOMIZED CONTROLLED TRIAL (TOPIC); UNLICENSED DRUG USE; VULNERABLE POPULATION; CLINICAL TRIAL (TOPIC); EUROPEAN UNION; LEGISLATION AND JURISPRUDENCE; NEONATOLOGY; UNITED STATES;

CLINICAL TRIALS AS TOPIC; DRUG EVALUATION; DRUG INDUSTRY; EUROPEAN UNION; HUMANS; INFANT, NEWBORN; NEONATOLOGY; UNITED STATES;

EID: 84906790701     PISSN: 13592998     EISSN: 14682052     Source Type: Journal    
DOI: 10.1136/archdischild-2013-305900     Document Type: Letter

References (4)

1. Milne CP, Davis J. The pediatric studies initiative: after 15 years have we reached the limits of the Law? Clin Ther 2014;36:156-62.
2. Wiles JR, Vinks AA, Akinbi H. Federal legislation and the advancement of neonatal drug studies. J Pediatr 2013;162:12-15.
3. Bourgeois FT, Murthy S, Pinto C, et al. Pediatric versus adult drug trials for conditions with high pediatric disease burden. Pediatrics 2012;130:285-92.
4. Boots I, Sukhai RN, Klein RH, et al. Stimulation programs for pediatric drug research - do children really bene fit? Eur J Pediatr 2007;166:849-55. (Pubitemid 46988181)