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The Indian Journal of Pediatrics

, Volume 86, Supplement 1, pp 10–14 | Cite as

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

  • Giulia Lorenzoni
  • Rosanna Irene Comoretto
  • Mariangela Ruffolo
  • Danila Azzolina
  • Ileana BaldiEmail author
Review Article
  • 20 Downloads

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.

Keywords

ClinicalTrials.gov Clinical trial Non-communicable diseases 

Notes

Author’s 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.

Compliance with Ethical Standards

Conflict of Interest

None.

Source of Funding

None.

References

  1. 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.Google Scholar
  2. 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.CrossRefGoogle Scholar
  3. 3.
    Medical Research Council (MRC). MRC Ethics Guide: Medical Research Involving Children. London: Medical Reserch Council; 2004.Google Scholar
  4. 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.CrossRefGoogle Scholar
  5. 5.
    Bavdekar SB. Pediatric clinical trials. Perspect Clin Res. 2013;4:89–99.CrossRefGoogle Scholar
  6. 6.
    Piantadosi S. Clinical trials. Chicester: Wiley-Blackwell; 2005.CrossRefGoogle Scholar
  7. 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.CrossRefGoogle Scholar
  8. 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. 9.
    Indian Council of Medical Research (ICMR). Ethical Guidelines for Biomedical Research on Human Subjects. 2006.Google Scholar
  10. 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.CrossRefGoogle Scholar
  11. 11.
    Breiman L. Out-of-bag estimation. ftp. stat. berkeley. edu/pub/users/breiman. OOBestimation ps. 1996;199(6).Google Scholar
  12. 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.CrossRefGoogle Scholar
  13. 13.
    Siegel KR, Patel SA, Ali MK. Non-communicable diseases in South Asia: contemporary perspectives. Br Med Bull. 2014;111:31–44.CrossRefGoogle Scholar
  14. 14.
    Williams K, Thomson D, Seto I, et al. Standard 6: age groups for pediatric trials. Pediatrics. 2012;129:S153–60.CrossRefGoogle Scholar
  15. 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.CrossRefGoogle Scholar
  16. 16.
    Bourgeois FT, Olson KL, Ioannidis JP, Mandl KD. Association between pediatric clinical trials and global burden of disease. Pediatrics. 2014;133:78–87.CrossRefGoogle Scholar
  17. 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.CrossRefGoogle Scholar
  18. 18.
    Bansal CP. Improving child health in India, how to set an agenda? Indian Pediatr. 2013;50:17–9.CrossRefGoogle Scholar
  19. 19.
    Srivastava RN. Right to health for children. Indian Pediatr. 2015;52:15–8.CrossRefGoogle Scholar
  20. 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.Google Scholar
  21. 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.CrossRefGoogle Scholar
  22. 22.
    Dunne J, Murphy MD, Rodriguez WJ. The globalization of pediatric clinical trials. Pediatrics. 2012;130:e1583–91.CrossRefGoogle Scholar

Copyright information

© Dr. K C Chaudhuri Foundation 2019

Authors and Affiliations

  • Giulia Lorenzoni
    • 1
  • Rosanna Irene Comoretto
    • 1
  • Mariangela Ruffolo
    • 1
  • Danila Azzolina
    • 1
  • Ileana Baldi
    • 1
    Email author
  1. 1.Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public HealthUniversity of PaduaPaduaItaly

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