British and Canadian views on the ethics of paediatric clinical trials

European Journal of Clinical Pharmacology

Volumn 63, Issue 5, 2007, Pages 431-436

  Sammons, H M ^a   Malhotra, J ^b   Choonara, I ^a   Sitar, D S ^c   Matsui, D ^b   Rieder, M J ^b  

^a UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^b CHILDREN S HOSPITAL OF WESTERN ONTARIO   (Canada)

^c UNIVERSITY OF MANITOBA   (Canada)

Author keywords

Child; Drug therapy; Ethics; Questionnaires

Indexed keywords

ANALGESIC AGENT; ANTIBIOTIC AGENT; ANTICONVULSIVE AGENT; ANTIINFLAMMATORY AGENT;

ARTICLE; CANADA; CLINICAL RESEARCH; CONTROLLED STUDY; CYSTIC FIBROSIS; DRUG SCREENING; EPILEPSY; ETHICS; HEALTH SURVEY; HUMAN; OTITIS MEDIA; PEDIATRICS; PILOT STUDY; PRIORITY JOURNAL; QUESTIONNAIRE; SEIZURE; TONSILLECTOMY; UNITED KINGDOM;

ATTITUDE OF HEALTH PERSONNEL; CANADA; CHILD; CONTROLLED CLINICAL TRIALS; CROSS-CULTURAL COMPARISON; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; GREAT BRITAIN; HUMAN EXPERIMENTATION; HUMANS; PEDIATRICS; PHYSICIANS; PILOT PROJECTS; PLACEBOS; QUESTIONNAIRES; RESEARCH PERSONNEL;

EID: 34147162932     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-007-0281-9     Document Type: Article

References (13)

1. McIntyre J, Conroy S, Avery A et al (2000) Unlicensed and off label prescribing of drugs in general practice. Arch Dis Child 83:498-501
2. Conroy S, McIntyre J, Choonara I (1999) Unlicensed and off label drug use in neonates. Arch Dis Child Fetal Neonatal Ed 80:F142-F145
3. Spielberg SP (2000) Paediatric therapeutics in the USA and internationally: an unparallel opportunity. Paed Perinatal Drug Ther 4:71-74
4. Food and Drug Administration Modernization Act (FDAMA) of 1997, Pub. L. No. 105-15, 105th Congress (Nov 21, 1997)
5. Best Pharmaceuticals for Children Act, Pub. L. No. 107-9, 107th Congress (Jan 4, 2002)
6. Saint-Raymond A, Seigneuret N (2005) Medicines for children: time for Europe to act. Paed Perinatal Drug Ther 6(3):142-146
7. Koren G, Kearns GL, Reed M et al (2003) Use of healthy children as volunteers in drug studies: the ethical debate. Clin Pharmacol Ther 73(3):147-152
8. Koren G (2003) Healthy children as subjects in pharmaceutical research. Theor Med 24:149-159
9. Jonsen A (2006) Nontherapeutic research with children: the Ramsey versus Mccormick debate. J Pediatr 149:S12-S14
10. Edwards SD, McNamee MJ (2005) Ethical concerns regarding guidelines for the conduct of clinical research on children. J Med Ethics 31:351-354
11. Ross L (2006) Phase 1 research and the meaning of direct benefit. J Pediatrics 149:S20-S24
12. Miller, Franklin G, Shorr AF (2002) Unnecessary use of placebo controls: the case of asthma clinical trials. Arch Int Med 162(15):1673-1677
13. McIntyre J, Robertson S, Norris E et al (2005) Safety and efficacy of buccal midazolam versus rectal diazepam for emergency treatment of seizures in children: a randomised controlled trial. Lancet 366:205-210