Press Release (ePRNews.com) - TORONTO - Sep 27, 2018 - In this live webinar, featured speakers from PRA Kirsten Sherman Cervati, Senior Director of the Center for Pediatric Clinical Development, and Dr. Harris W. Dalrymple, Executive Director – Scientific Affairs and Vice-Chair of the Center for Pediatric Clinical Development, will explore the implications of recent U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines and mechanisms to incorporate child and youth engagement at various points of the clinical trial process.
Both FDA and EMA have issued specific guidance on inclusion of the patient perspective in the clinical trial process. Section 3011 of the 21st Century Cures Act, signed into U.S. law in December 2016, requires that tools used to report patient outcomes are validated per each age-appropriate population. The EMA’s ethical guidelines (e.g., ethical considerations for clinical trials on medicinal products conducted with minors, Revision 1, 18 September 2017) mandate that pediatric clinical trials are relevant to the population represented by the minors concerned. All questionnaires, patient-reported outcomes and other similar instruments must now demonstrate validation. At the recent annual workshop of the European Network of Paediatric Research at EMA (Enpr-EMA), several speakers emphasized the advantages of involving the target patient group and their parents in discussions regarding the content and format of information sheets and assent forms; the relevance of proposed endpoints; and the practical aspects and related challenges of executing the protocol.
The International Children’s Advisory Network (iCAN) has chapters in many countries and provides guidance regarding the topics above. Several young persons advisory groups exist at local levels and often provide similar counsel. While young people, aged 12 years and older, are represented by most advisory groups, few of the groups consider the interests of children under 12.
Join the informative and interactive discussion on Tuesday, Oct. 16, 2018, at 11 a.m. EDT (4 p.m. BST/UK).
For more information or to register for this event, visit Routes to Improve Pediatric Patient Engagement in Clinical Trials.
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Nima Rajan Source :
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