StaR child health: Developing evidence-based guidance for the design, conduct, and reporting of pediatric trials

Clinical Pharmacology and Therapeutics

Volumn 90, Issue 5, 2011, Pages 727-731

  Hartling, L ^a   Wittmeier, K D M ^b   Caldwell, P H ^c   Van Der Lee, J H ^d   Klassen, T P ^e   Craig, J C ^c   Offringa, M ^d  

^a UNIVERSITY OF ALBERTA   (Canada)

^b WINNIPEG REGIONAL HEALTH AUTHORITY   (Canada)

^c CHILDREN S HOSPITAL AT WESTMEAD   (Australia)

^d EMMA CHILDREN S HOSPITAL   (Netherlands)

^e Manitoba Institute of Child Health   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CHILD HEALTH; DATA ANALYSIS; EVIDENCE BASED MEDICINE; HUMAN; INFORMED CONSENT; MEDICAL RESEARCH; PATIENT SAFETY; PEDIATRIC ADVANCED LIFE SUPPORT; PRIORITY JOURNAL; SAMPLE SIZE; SYSTEMATIC ERROR;

CHILD; CHILD WELFARE; CLINICAL TRIALS AS TOPIC; EVIDENCE-BASED MEDICINE; GUIDELINES AS TOPIC; HUMANS; INTERNATIONAL COOPERATION; PEDIATRICS; PHARMACEUTICAL PREPARATIONS; RESEARCH DESIGN; WORLD HEALTH;

EID: 80055023973     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2011.212     Document Type: Article

References (35)

1. United Nations General Assembly. Resolution 25 session 44 Convention on the Rights of the Child, 20 November 1989.
2. Caldwell, P.H., Murphy, S.B., Butow, P.N. & Craig, J.C. Clinical trials in children. Lancet 364, 803-811 (2004). (Pubitemid 39165102)
3. Martinez-Castaldi, C., Silverstein, M. & Bauchner, H. Child versus adult research: the gap in high-quality study design. Pediatrics 122, 52-57 (2008).
4. Cohen, E., Uleryk, E., Jasuja, M. & Parkin, P.C. An absence of pediatric randomized controlled trials in general medical journals, 1985-2004. J. Clin. Epidemiol. 60, 118-123 (2007). (Pubitemid 46039874)
5. Cohen, E. et al. Child vs adult randomized controlled trials in specialist journals: a citation analysis of trends, 1985-2005. Arch. Pediatr. Adolesc. Med. 164, 283-288 (2010).
6. Rodriguez, W., Roberts, R. & Murphy, D. Adverse drug events in children: the US Food and Drug Administration perspective. Curr. Ther. Res. 62, 711-723 (2001). (Pubitemid 33097455)
7. Graham, I.D. et al. Lost in knowledge translation: time for a map? J. Contin. Educ. Health Prof. 26, 13-24 (2006).
8. Frakking, F.N.J., van der Lee, J.H., Klassen, T.P. & Offringa, M., for the StaR Child Health Group. Survey of current guidance for child health clinical trails. 2009. The StaR Child Health Project: Standards for Research with Children 〈http://www.who.int/childmedicines/publications/ GUIDANCECHILDHEALTH.pdf〉.
9. Klassen, T.P., Hartling, L., Hamm, M., van der Lee, J.H., Ursum, J. & Offringa, M. StaR Child Health: an initiative for RCTs in children. Lancet 374, 1310-1312 (2009).
10. Caldwell, P.H., Butow, P.N. & Craig, J.C. Parents' attitudes to children's participation in randomized controlled trials. J. Pediatr. 142, 554-559 (2003). (Pubitemid 36623567)
11. Higgins, J.P.T. & Green, S. (eds). Cochrane Handbook for Systematic Reviews of Interventions, version 5.1.0 [updated March 2011]. The Cochrane Collaboration 〈http://www.cochrane-handbook.org/〉 (2011).
12. Hartling, L. et al. Risk of bias versus quality assessment of randomised controlled trials: cross sectional study. BMJ 339, b4012 (2009).
13. Hamm, M.P. et al. A descriptive analysis of a representative sample of pediatric randomized controlled trials published in 2007. BMC Pediatr. 10, 96 (2010).
14. DeAngelis, C.D. et al.; International Committee of Medical Journal Editors. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA 292, 1363-1364 (2004).
15. Sammons, H.M., Gray, C., Hudson, H., Cherrill, J. & Choonara, I. Safety in paediatric clinical trials-a 7-year review. Acta Paediatr. 97, 474-477 (2008). (Pubitemid 351432298)
16. Bassler, D., Montori, V.M., Briel, M., Glasziou, P. & Guyatt, G. Early stopping of randomized clinical trials for overt efficacy is problematic. J. Clin. Epidemiol. 61, 241-246 (2008).
17. Briel, M. et al. Stopping randomized trials early for benefit: a protocol of the Study of Trial Policy of Interim Truncation-2 (STOPIT-2). Trials 10, 49 (2009).
18. Montori, V.M. et al. Randomized trials stopped early for benefit: a systematic review. JAMA 294, 2203-2209 (2005). (Pubitemid 41571138)
19. Fernandes, R.M., van der Lee, J.H. & Offringa, M. A systematic review of the reporting of data monitoring committees' roles, interim analysis and early termination in pediatric clinical trials. BMC Pediatr. 9, 77 (2009).
20. Fernandes, R.M., van der Lee, J.H. & Offringa, M. Data monitoring committees, interim analysis and early termination in paediatric trials. Acta Paediatr. (2011); e-pub ahead of print 21 March 2011.
21. Campbell, H., Surry, S.A. & Royle, E.M. A review of randomised controlled trials published in Archives of Disease in Childhood from 1982-96. Arch. Dis. Child. 79, 192-197 (1998). (Pubitemid 28384861)
22. Steinbrook, R. Testing medications in children. N. Engl. J. Med. 347, 1462-1470 (2002). (Pubitemid 35239728)
23. European Medicines Agency. EMEA reflection paper: formulations of choice for the paediatric population 〈http://www.emea.europa.eu/pdfs/human/ paediatrics/19481005en.pdf〉 (2009).
24. Norman, E., Malmqvist, U., Westrin, P. & Fellman, V. Thiopental pharmacokinetics in newborn infants: a case report of overdose. Acta Paediatr. 98, 1680-1682 (2009).
25. World Health Organization (WHO). Make Medicines Child Size 〈http://www.who.int/childmedicines/en/〉 accessed 11 July 2011.
26. Caldwell, P.H., Butow, P.N. & Craig, J.C. Pediatricians' attitudes toward randomized controlled trials involving children. J. Pediatr. 141, 798-803 (2002). (Pubitemid 35471641)
27. Rheims, S., Cucherat, M., Arzimanoglou, A. & Ryvlin, P. Greater response to placebo in children than in adults: a systematic review and meta-analysis in drug-resistant partial epilepsy. PLoS Med. 5, e166 (2008).
28. Fernandes, R., Ferreira, J.J. & Sampaio, C. The placebo response in studies of acute migraine. J. Pediatr. 152, 527-33, 533.e1 (2008).
29. Sinha, I., Jones, L., Smyth, R.L. & Williamson, P.R. A systematic review of studies that aim to determine which outcomes to measure in clinical trials in children. PLoS Med. 5, e96 (2008).
30. Clarke, M. Standardising outcomes for clinical trials and systematic reviews. Trials 8, 39 (2007).
31. Kaptchuk, T.J. The double-blind, randomized, placebo-controlled trial: gold standard or golden calf? J. Clin. Epidemiol. 54, 541-549 (2001). (Pubitemid 32453346)
32. Shah, S. Globalization of clinical research by the pharmaceutical industry. Int. J. Health Serv. 33, 29-36 (2003). (Pubitemid 36350823)
33. Emanuel, E.J., Currie, X.E. & Herman, A.; Project Phidisa. Undue inducement in clinical research in developing countries: is it a worry? Lancet 366, 336-340 (2005). (Pubitemid 41019426)
34. Apateerapong, W. & Ananworanich, J. Participation in randomized trials in developing countries. J. Pediatr. 144, 140; author reply 140 (2004). (Pubitemid 38091438)
35. Hopewell, S. et al.; CONSORT Group. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 5, e20 (2008).