Skip to main content

Advertisement

SpringerLink
Log in

Pediatric Trials Run in India: An Analysis of Clinical Trials.gov 2006–2015

  • Review Article
  • Published:
The Indian Journal of Pediatrics Aims and scope Submit manuscript

Abstract

Objective

To present a snapshot of 10 y of pediatric research, with a focus on trials with at least one enrolling site in India.

Methods

The study included all interventional trials registered at ClinicalTrials.gov from January 2006 through December 2015, enrolling patients aged 0 to 18 y. The database for Aggregate Analysis of ClinicalTrials.gov (AACT) was the data source used.

Results

Nine thousand, six hundred forty-eight pediatric clinical studies were identified. Of these, 193 had at least one enrolling site in India. The primary purpose for most of these trials was treatment (n = 92) and prevention (n = 65) coupled with an efficacy and/or safety endpoint (n = 158). Infant and toddlers were eligible for enrollment in the majority of trials (97%) while neonates only in 22% of trials. The rate of early termination or withdrawal was 5%. The most commonly studied conditions were bacterial infections, viruses, digestive and mental diseases. Overall, communicable diseases (n = 75) and major non-communicable diseases (n = 72) were equally investigated.

Conclusions

The most commonly studied therapeutic areas in trials enrolling from India and registered in ClinicalTrials.gov were appropriate for India public health needs and patients were not enrolled into studies inappropriately from this perspective.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Joseph PD, Craig JC, Tong A, Caldwell PH. Researchers’, regulators’, and sponsors’ views on pediatric clinical trials: a multinational study. Pediatrics. 2016;138:pii:e20161171.

  2. MacLeod SM, Knoppert DC, Stanton-Jean M, Avard D. Pediatric clinical drug trials in low-income countries: key ethical issues. Paediatr Drugs. 2015;17:83–90.

    Article  CAS  PubMed  Google Scholar 

  3. Medical Research Council (MRC). MRC Ethics Guide: Medical Research Involving Children. London: Medical Reserch Council; 2004.

    Google Scholar 

  4. Grimsrud KN, Sherwin CM, Constance JE, et al. Special population considerations and regulatory affairs for clinical research. Clin Res Regul Aff. 2015;32:47–56.

    Article  PubMed  PubMed Central  Google Scholar 

  5. Bavdekar SB. Pediatric clinical trials. Perspect Clin Res. 2013;4:89–99.

    Article  PubMed  PubMed Central  Google Scholar 

  6. Piantadosi S. Clinical trials. Chicester: Wiley-Blackwell; 2005.

    Book  Google Scholar 

  7. Turner MA, Catapano M, Hirschfeld S, Giaquinto C. Global research in paediatric drug development: the impact of evolving regulations. Adv Drug Deliv Rev. 2014;73:2–13.

    Article  CAS  PubMed  Google Scholar 

  8. Indian Council of Medical Research (ICMR). National Ethics Guidelines for Biomedical Research Involving Children. New Delhi: Indian Council of Medical Research; 2017. Available at:www.icmr.nic.in/sites/default/files/guidelines/National_Ethical_Guidelines_for_Biomedical_Research_Involving_Children_0.pdf. Accessed 20 Nov 2018.

  9. Indian Council of Medical Research (ICMR). Ethical Guidelines for Biomedical Research on Human Subjects. 2006.

  10. Tasneem A, Aberle L, Ananth H, et al. The database for aggregate analysis of ClinicalTrials.gov (AACT) and subsequent regrouping by clinical specialty. PLoS One. 2012;7:e33677.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  11. Breiman L. Out-of-bag estimation. ftp. stat. berkeley. edu/pub/users/breiman. OOBestimation ps. 1996;199(6).

  12. Pasquali SK, Lam WK, Chiswell K, Kemper AR, Li JS. Status of the pediatric clinical trials enterprise: an analysis of the US ClinicalTrials.gov registry. Pediatrics. 2012;130:e1269–77.

    Article  PubMed  PubMed Central  Google Scholar 

  13. Siegel KR, Patel SA, Ali MK. Non-communicable diseases in South Asia: contemporary perspectives. Br Med Bull. 2014;111:31–44.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Williams K, Thomson D, Seto I, et al. Standard 6: age groups for pediatric trials. Pediatrics. 2012;129:S153–60.

    Article  PubMed  Google Scholar 

  15. Kshirsagar N, Swaminathan S, Jog P, et al. Regulatory and ethical issues in pediatric clinical research: recommendations from a panel discussion. J Clin Pharmacol. 2017;57:943–6.

    Article  CAS  PubMed  Google Scholar 

  16. Bourgeois FT, Olson KL, Ioannidis JP, Mandl KD. Association between pediatric clinical trials and global burden of disease. Pediatrics. 2014;133:78–87.

    Article  PubMed  PubMed Central  Google Scholar 

  17. Global Burden of Disease Pediatrics C, Kyu HH, Pinho C, Wagner JA, et al. Global and national burden of diseases and injuries among children and adolescents between 1990 and 2013: findings from the global burden of disease 2013 study. JAMA Pediatr. 2016;170:267–87.

    Article  Google Scholar 

  18. Bansal CP. Improving child health in India, how to set an agenda? Indian Pediatr. 2013;50:17–9.

    Article  CAS  PubMed  Google Scholar 

  19. Srivastava RN. Right to health for children. Indian Pediatr. 2015;52:15–8.

    Article  CAS  PubMed  Google Scholar 

  20. Viergever RF, Li K. Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013. BMJ Open. 2015;5:e008932.

  21. Baldi I, Lanera C, Berchialla P, Gregori D. Early termination of cardiovascular trials as a consequence of poor accrual: analysis of ClinicalTrials.gov 2006–2015. BMJ Open. 2017;7:e013482.

    Article  PubMed  PubMed Central  Google Scholar 

  22. Dunne J, Murphy MD, Rodriguez WJ. The globalization of pediatric clinical trials. Pediatrics. 2012;130:e1583–91.

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy

    Giulia Lorenzoni, Rosanna Irene Comoretto, Mariangela Ruffolo, Danila Azzolina & Ileana Baldi

Authors
  1. Giulia Lorenzoni
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Rosanna Irene Comoretto
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Mariangela Ruffolo
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Danila Azzolina
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Ileana Baldi
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

IB designed the study; IB and GL wrote the manuscript; DA performed the statistical analysis; MR and RIC critically revised the manuscript and contributed to the discussion. All authors contributed to results interpretation, read and approved the final manuscript. IB will act as guarantor for this paper.

Corresponding author

Correspondence to Ileana Baldi.

Ethics declarations

Conflict of Interest

None.

Source of Funding

None.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Lorenzoni, G., Comoretto, R.I., Ruffolo, M. et al. Pediatric Trials Run in India: An Analysis of Clinical Trials.gov 2006–2015. Indian J Pediatr 86 (Suppl 1), 10–14 (2019). https://doi.org/10.1007/s12098-018-2825-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12098-018-2825-7

Keywords

Search

Navigation