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Standardising neonatal and paediatric antibiotic clinical trial design and conduct: the PENTA-ID network view.

Folgori, L; Lutsar, I; Standing, JF; Walker, AS; Roilides, E; Zaoutis, TE; Jafri, H; Giaquinto, C; Turner, MA; Sharland, M (2019) Standardising neonatal and paediatric antibiotic clinical trial design and conduct: the PENTA-ID network view. BMJ Open, 9 (12). e032592. ISSN 2044-6055 https://doi.org/10.1136/bmjopen-2019-032592
SGUL Authors: Folgori, Laura

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Abstract

Antimicrobial development for children remains challenging due to multiple barriers to conducting randomised clinical trials (CTs). There is currently considerable heterogeneity in the design and conduct of paediatric antibiotic studies, hampering comparison and meta-analytic approaches. The board of the European networks for paediatric research at the European Medicines Agency (EMA), in collaboration with the Paediatric European Network for Treatments of AIDS-Infectious Diseases network (www.penta-id.org), recently developed a Working Group on paediatric antibiotic CT design, involving academic, regulatory and industry representatives. The evidence base for any specific criteria for the design and conduct of efficacy and safety antibiotic trials for children is very limited and will evolve over time as further studies are conducted. The suggestions being put forward here are based on the adult EMA guidance, adapted for neonates and children. In particular, this document provides suggested guidance on the general principles of harmonisation between regulatory and strategic trials, including (1) standardised key inclusion/exclusion criteria and widely applicable outcome measures for specific clinical infectious syndromes (CIS) to be used in CTs on efficacy of antibiotic in children; (2) key components of safety that should be reported in paediatric antibiotic CTs; (3) standardised sample sizes for safety studies. Summarising views from a range of key stakeholders, specific criteria for the design and conduct of efficacy and safety antibiotic trials in specific CIS for children have been suggested. The recommended criteria are intended to be applicable to both regulatory and clinical investigator-led strategic trials and could be the basis for harmonisation in the design and conduct of CTs on antibiotics in children. The next step is further discussion internationally with investigators, paediatric CTs networks and regulators.

Item Type: Article
Additional Information: © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Keywords: antibiotics, clinical trials, paediatrics
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Journal or Publication Title: BMJ Open
ISSN: 2044-6055
Language: eng
Dates:
DateEvent
31 December 2019Published
29 November 2019Accepted
Publisher License: Creative Commons: Attribution-Noncommercial 4.0
PubMed ID: 31892658
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/111552
Publisher's version: https://doi.org/10.1136/bmjopen-2019-032592

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