Speakers for this Event: John van den Anker, MD, Vice Chair of Pediatrics for Experimental Therapeutics and Director of Pediatric Clinical Pharmacology at Children’s National Medical Center (Washington, DC) Ginger Steinhilber RN.MS. CCRC, Clinical Research Manager, Children’s Hospital of Michigan and  Wayne State University Moderator: Kathy Bohannon, Principal Strategist, Pediatrics, INC Research

As part of this 2012 quarterly webinar series focused on pediatric research, speakers John van den Anker, MD and Ginger Steinhilber, RN will discuss key elements for clinical research in pediatric patients from the point of view of the research site and the investigator. They will discuss what sites and investigators require from all stakeholders in the process: sponsors, CROs, ethics committees, patients and parents, IRBs, GCRCs, pediatric scientific committees and the FDA. They will cover how they evaluate participation in certain pediatric studies.

Speakers will also discuss how they document their processes, including development of informed consent and assent forms. They will share their roles in patient recruitment and strategies that have been effective (and not effective) in patient recruitment and retention for pediatric populations, including what resources and tools are needed and key reasons that families decline participation and drop out of studies. They will also explore the unique considerations for recruitment of PK studies and how to overcome challenges associated with those trials.

For those patients and families that do participate, there are many considerations and factors that drive patient and family compliance. Study design and format, therapeutic indication and length of trial weigh into decisions and compliance by patients and their families. Speakers will address what types of patients/parents are most compliant, why that is and what tools and resources are needed to help patients and families

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