This review evaluates the impact of recent US and European regulatory initiatives on the landscape of pediatric cardiovascular clinical trials to inform future trial design.
May inform pediatric cardiovascular trial adaptations under new regulations; leaves open optimal designs for future studies.
Recent regulatory initiatives in the United States of America and Europe have transformed the paediatric clinical trials landscape by significantly increasing capital investment and paediatric trial volume. The purpose of this manuscript was to review the impact of these initiatives on the paediatric cardiovascular trials landscape when compared with other paediatric sub-specialties. We also evaluate factors that may have contributed to the success or failure of recent major paediatric cardiovascular trials so as to inform the optimal design and conduct of future trials in the field.
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Hill et al. (2015) studied this question.
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