Evaluating Safety Reporting in Paediatric Antibiotic Trials, 2000–2016: A Systematic Review and Meta-Analysis

Author:

Pansa Paola,Hsia Yingfen,Bielicki Julia,Lutsar Irja,Walker A. Sarah,Sharland Mike,Folgori LauraORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical)

Reference116 articles.

1. Guidance for Industry. The Content and Format for Pediatric Use Supplements. Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). 1996. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071957.pdf . Accessed 15 Feb 2017.

2. European Medicines Agency. The European paediatric initiative: History of the Paediatric Regulation (EMEA/17967/04 Rev 1). 2007. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/09/WC500003693.pdf . Accessed 15 Feb 2017.

3. Folgori L, Bielicki J, Ruiz B, et al. Harmonisation in study design and outcomes in paediatric antibiotic clinical trials: a systematic review. Lancet Infect Dis. 2016;16(9):e178–89.

4. European Medicines Agency. Concept paper on an addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 2) to address paediatric-specific clinical data requirements (EMA/CHMP/213862/2016). 2016. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/04/WC500205026.pdf . Accessed 15 Feb 2017.

5. Clinical Trials Transformation Initiative. Improving pediatric trials in antibacterial drug development: no sick child left behind. Summary of the Meeting held April 5, 2016. https://www.ctti-clinicaltrials.org/files/ctti-pedstrials-expertmeeting-summary.pdf . Accessed 15 Feb 2017.

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