The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both issued specific guidance on inclusion of the patient perspective in the clinical trial process. Section 3011 of the 21st Century Cures Act, signed into US law in December 2016, requires that tools used to report patient outcomes are validated per each age-appropriate population. The EMA’s ethical guidelines (eg. 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.
During this webinar, featured speakers will explore the implications of these guidelines and mechanisms to incorporate child and youth engagement at various points of the clinical trial process.
Kirsten Sherman Cervati, Senior Director, Center for Pediatric Clinical Development, PRA Health Sciences
Kirsten Sherman Cervati is Senior Director of PRA’s Center for Pediatric Clinical Development and leads the PRA Pediatric Site Network. She has more than 20 years of industry experience including positions in operations and global team management with an emphasis on feasibility and investigative site relationships. Ms. Sherman Cervati seeks to advance treatment options for the pediatric population, motivated as a professional in this field and as a parent of a child with a chronic disease. She serves on the external advisory board of the International Children’s Advisory Network (iCAN) and recently accepted the leadership position of iCAN’s Parent Council.
Dr. Harris W. Dalrymple, Executive Director - Scientific Affairs and Vice-Chair of the Center for Pediatric Clinical Development, PRA Health Sciences
Harris Dalrymple, PhD, MS, Executive Director, Scientific Affairs, Vice-Chair, Center for Pediatric Clinical Development (CPCD), has more than 35 years of experience in the pharmaceutical and CRO sectors. Prior to joining PRA, Dr. Dalrymple spent 10 years in project management at a leading global CRO where he was the operational lead for a large strategic client, led support for a gene therapy product, and was the vice-chair of the Pediatric Working Group. Dr. Dalrymple also worked at Pfizer for nearly 25 years in a variety of roles within discovery, clinical development, and development operations, where he led project teams and held a wide range of managerial positions. Dr. Dalrymple has more than 15 years’ experience in conducting pediatric clinical trials that encompass most therapeutic areas. He holds a master’s degree in medical law and ethics and a doctorate in law. He is a core lecturer on the Faculty of Pharmaceutical Medicine Course run by the British Association of Pharmaceutical Physicians.
Who Should Attend?
- Those interested in patient-centric approaches to facilitate clinical research
- C-level and senior professionals from biotechnology companies involved in research and development
- Procurement and outsourcing professionals
- Senior professionals from biopharmaceutical companies working on rare disease compounds
Relevant job functions include:
- Research & Development
- Clinical Affairs
- Clinical Research
- Clinical Pharmacology
- Clinical Operations
- Medical Affairs
- Project Management
What You Will Learn
Join this webinar to learn about:
- New regulations which require that all questionnaires, patient-reported outcomes, and other similar instruments used in pediatric trials must now demonstrate validation
- The advantages of involving the target patient group and their parents in discussions related to the study protocol
- How to incorporate child and youth engagement at various points of the clinical trial process
There’s no better investment in the future than today’s children. The Center for Pediatric Clinical Development at PRA honors that belief through a conscious and effective focus on the development of pediatric clinical breakthroughs. At the center of all pediatric clinical development is the patient, and we have a team specifically assembled to leverage this quality of care. We are dedicating our time and expertise to find the right solutions for our clients’ pediatric studies at the right time. We never lose sight of our goal: a better tomorrow for our children.