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Challenges and opportunities for conducting neonatal clinical trials in low- and middle-income countries

Journal of Perinatology volume 39, pages 1–2 (2019)Cite this article

Designing and implementing randomized controlled clinical trials (RCTs) can be challenging. Besides handling complex scientific issues, the investigators must resolve logistical matters, such as obtaining approvals from various entities and handling regulatory issues. Testing new drugs in vulnerable populations can be even more challenging, as are studies to be conducted in low- and lower-middle-income countries (LICs, and L-MICs) designated by the World Bank [1].

Three papers in this issue of the Journal highlight the above points. Indian investigators conducted a multicenter RCT using goat-lung-surfactant extract (GLSE), a domestically developed, low-cost drug, comparing it with a commercial surfactant in infants suffering from respiratory distress syndrome. A secondary analysis of death and the grueling experience of designing and conducting this RCT are the topics of the other two papers.

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References

  1. The World Bank. New country classifications by income level: 2018–2019. https://blogs.worldbank.org/opendata/new-country-classifications-income-level-2018-2019 Accessed 29 May 2019.

  2. U.S. Food and Drug Administration. Development & Approval Process (Drugs) https://www.fda.gov/drugs/development-approval-process-drugs Accessed 29 May 2019.

  3. National Institutes of Health. Single IRB Policy for Multi-site Research https://grants.nih.gov/policy/humansubjects/single-irb-policy-multi-site-research.htm Accessed 29 May 2019.

  4. Althabe F, Belizán J, McClure E, Hemingway-Foday JA, Berrueta M, Mazzoni A, et al. A population-based multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: the ACT cluster-randomised trial. Lancet 2015;385:629–39.

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  5. Dutta V. Therapeutic hypothermia for birth asphyxia in neonates. Indian J Pediatr. 2017;84:219–26.

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Acknowledgements

Publication of this supplement was funded by Wellcome, United Kingdom.

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  1. F. Edward Hébert School of Medicine, Uniformed Services University, Bethesda, MD, 20814, USA

    Tonse N. K. Raju

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  1. Tonse N. K. Raju
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Correspondence to Tonse N. K. Raju.

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The author serves as Deputy Editor for Journal of Perinatology, and declared that he has no conflict of interest.

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Raju, T.N.K. Challenges and opportunities for conducting neonatal clinical trials in low- and middle-income countries. J Perinatol 39 (Suppl 1), 1–2 (2019). https://doi.org/10.1038/s41372-019-0470-2

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