European Journal of Clinical Pharmacology

, Volume 65, Issue 9, pp 873–880 | Cite as

Children’s presence in research. A review of online registers

Review Article

Abstract

Objectives

To determine how many online clinical trial registers include paediatric trial data, how much information is provided, ease of searching for paediatric trials and the accessibility of paediatric trial data in general.

Methods

Medline and Google were searched for mention of clinical trial registers in July 2008. All registers considered to be eligible were evaluated for trial information provided, search options available, and number of trials, both total and paediatric. A meta-analytic weighted average of the presence of paediatric trials was calculated and compared to the percentage of published paediatric trial articles in Medline. The paediatric trials in the registers were searched for in the World Health Organization's International Clinical Trials Registry Platform (ICTRP). All online, freely accessible registers including ongoing trials on different drugs or therapeutic areas, were eligible for review.

Results

Twelve registers were included in the review. All except one provided detailed trial data, while search options varied between registers: seven provided free-text searching, two listed their trials by condition, two provided elaborate search options (age group, condition, study purpose, etc) and one simply listed its trials. Nine of the 12 registers’ search facilities made it possible to search for paediatric trials, and these were analysed further: the percentage of paediatric trials in the single registers ranged from 4.8 to 33.3%, and the weighted average was 15% (95% confidence interval 8.2–21.8). The percentage of published, paediatric trial articles was 25%. Of the paediatric trials also searched for in the ICTRP, 66% were found.

Conclusions

Great difficulty was found in retrieving paediatric trials due to the limited and inadequate search functions of the registers reviewed but, in general, the registers seem to represent fewer paediatric trials than those reported in the literature. The ICTRP portal is important for trial accessibility, but it is still in an initial phase and far from representative of the global research situation, especially in the field of paediatrics.

Keywords

Clinical trials as topic Internet Pediatrics Registries Review 

Abbreviations

EMEA

European Medicines Agency

ICMJE

International Committee of Medical Journal Editors

ICTRP

International Clinical Trials Registry Platform

MeSH

Medical Subject Headings

References

  1. 1.
    Bonati M, Pandolfini C, Clavenna A (2004) Disclosure of clinical trials in children. Science 305:1401PubMedCrossRefGoogle Scholar
  2. 2.
    Clavenna A, Pandolfini C, Bonati M (2002) Public disclosure of clinical trials in children. Curr Ther Res Clin Exp 63:707–716CrossRefGoogle Scholar
  3. 3.
    Dickersin K, Rennie D (2003) Registering clinical trials. JAMA 290:516–523PubMedCrossRefGoogle Scholar
  4. 4.
    Conen D, Torres J, Ridker PM (2008) Differential citation rates of major cardiovascular clinical trials according to source of funding: a survey from 2000 to 2005. Circulation 118:1321–1327PubMedCrossRefGoogle Scholar
  5. 5.
    Dowd MD (2004) Breaching the contract: the ethics of nonpublication of research studies. Arch Pediatr Adolesc Med 158:1014–1015PubMedCrossRefGoogle Scholar
  6. 6.
    Hartling L, Craig WR, Russell K, Stevens K, Klassen TP (2004) Factors influencing the publication of randomized controlled trials in child health research. Arch Pediatr Adolesc Med 158:983–987PubMedCrossRefGoogle Scholar
  7. 7.
    Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E et al (2008) Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS ONE 3:e3081PubMedCrossRefGoogle Scholar
  8. 8.
    Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R (2008) Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 358:252–260PubMedCrossRefGoogle Scholar
  9. 9.
    Hopewell S, McDonald S, Clarke M, Egger M (2007) Grey literature in meta-analyses of randomized trials of health care interventions. Cochrane Database Syst Rev MR000010Google Scholar
  10. 10.
    Klassen TP, Wiebe N, Russell K, Stevens K, Hartling L, Craig WR et al (2002) Abstracts of randomized controlled trials presented at the society for pediatric research meeting: an example of publication bias. Arch Pediatr Adolesc Med 156:474–479PubMedGoogle Scholar
  11. 11.
    Rennie D (2004) Trial registration: a great idea switches from ignored to irresistible. JAMA 292:1359–1362PubMedCrossRefGoogle Scholar
  12. 12.
    Dyer O (2004) GlaxoSmithKline faces US lawsuit over concealment of trial results. Br Med J 328:1395CrossRefGoogle Scholar
  13. 13.
    De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R et al (2004) Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med 351:1250–1251PubMedCrossRefGoogle Scholar
  14. 14.
    De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R et al (2005) Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. JAMA 293:2927–2929CrossRefGoogle Scholar
  15. 15.
    Reveiz L, Krleza-Jeric K, Chan AW, De AS (2007) Do trialists endorse clinical trial registration? Survey of a Pubmed sample. Trials 8:30PubMedCrossRefGoogle Scholar
  16. 16.
    Smyth RL (2001) Research with children. Paediatric practice needs better evidence--gained in collaboration with parents and children. Br Med J 322:1377–1378CrossRefGoogle Scholar
  17. 17.
    Saint Raymond A, Brasseur D (2005) Development of medicines for children in Europe: ethical implications. Paediatr Respir Rev 6:45–51PubMedCrossRefGoogle Scholar
  18. 18.
    Caldwell PH, Murphy SB, Butow PN, Craig JC (2004) Clinical trials in children. Lancet 364:803–811PubMedCrossRefGoogle Scholar
  19. 19.
    European Parliament and the Council of the European Union (2006) Regulation (EC) No 1902/2006 of the European Parliament and the Council on medicinal products for paediatric use. Publication date 27/12/2006 (L 378/20). Official Journal of the European Union, Brussels Google Scholar
  20. 20.
    Klassen TP, Hartling L, Craig JC, Offringa M (2008) Children are not just small adults: the urgent need for high-quality trial evidence in children. PLoS Med 5:e172PubMedCrossRefGoogle Scholar
  21. 21.
    Pandolfini C, Bonati M (2008) European paediatric research and children's therapeutic needs. A trial review. Acta Paediatr 97:1232–1237PubMedCrossRefGoogle Scholar
  22. 22.
    Cohen E, Uleryk E, Jasuja M, Parkin PC (2007) An absence of pediatric randomized controlled trials in general medical journals, 1985–2004. J Clin Epidemiol 60:118–123PubMedCrossRefGoogle Scholar
  23. 23.
    (2004) The time is coming [Editorial]. Nat Rev Drug Discov 3:897–898Google Scholar
  24. 24.
    Zarin DA, Tse T, Ide NC (2005) Trial registration at ClinicalTrials.gov between May and October 2005. N Engl J Med 353:2779–2787PubMedCrossRefGoogle Scholar
  25. 25.
    Grobler L, Siegfried N, Askie L, Hooft L, Tharyan P, Antes G (2008) National and multinational prospective trial registers. Lancet 372:1201–1202PubMedCrossRefGoogle Scholar
  26. 26.
    Gulmezoglu AM, Pang T, Horton R, Dickersin K (2005) WHO facilitates international collaboration in setting standards for clinical trial registration. Lancet 365:1829–1831PubMedCrossRefGoogle Scholar
  27. 27.
    Bonati M, Pandolfini C, Rossi V, Santoro E, de Bolos JM Arnau, Danés Carreras I et al (2004) Launch of a European paediatric clinical trials register. Paediatr Perinat Drug Ther 6:38–39CrossRefGoogle Scholar
  28. 28.
    Bonati M, Pandolfini C (2005) More on compulsory registration of clinical trials: complete clinical trial register is already reality for paediatrics. Br Med J 330:480CrossRefGoogle Scholar

Copyright information

© Springer-Verlag 2009

Authors and Affiliations

  1. 1.Laboratory for Mother and Child Health, Department of Public Health“Mario Negri” Pharmacological Research InstituteMilanItaly

Personalised recommendations