Journal article
Safety reporting in neonatal clinical trials: reflections towards optimal, globally relevant approaches
- Abstract:
- Adverse event (AE) collection is a key part of evidence generation in clinical trials and an integral element of safety reporting. AE assessment and documentation is particularly challenging in neonates who are a heterogeneous population with high rates of co-morbidities. Neonatal research is finally gaining the attention of regulators regarding drug development and the need for optimal dosing specific to this population. However, further efforts are necessary to ensure that adverse events (AEs) are adequately collected, allowing for the generation of essential safety data. It is also crucial that the methodology used aligns with the intended trial outcomes to minimise the burden on trial sites. In resource-constrained settings, where pharmacovigilance implementation can be particularly challenging, a pragmatic approach to safety reporting is even more important given the significant public health need for effective drugs. This commentary reflects on some of the challenges and potential areas of improvement in safety reporting that could be addressed in future neonatal-focused trials.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
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(Preview, Version of record, pdf, 651.3KB, Terms of use)
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- Publisher copy:
- 10.1186/s13063-025-08723-y
Authors
- Publisher:
- BioMed Central
- Journal:
- Trials More from this journal
- Volume:
- 26
- Issue:
- 1
- Article number:
- 46
- Publication date:
- 2025-02-09
- Acceptance date:
- 2024-12-31
- DOI:
- EISSN:
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1745-6215
- Language:
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English
- Keywords:
- Pubs id:
-
2074328
- Local pid:
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pubs:2074328
- Deposit date:
-
2025-01-03
Terms of use
- Copyright holder:
- Hill et al
- Copyright date:
- 2025
- Rights statement:
- © The Author(s) 2025. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
- Licence:
- CC Attribution (CC BY)
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