Program Description

Pediatric Clinical Trials Conference

Goal: The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research Professionals responsible for the activities at the research site or institution. The purpose of this workshop is to assist Research Professionals in improving their skills and their understanding of the responsibilities of conducting clinical research in the pediatric population. 

Clinical research in pediatric populations must follow the same regulations that adult clinical research follows, yet there are additional safeguards for children in clinical research, challenges associated with consent and study management for families as well as nuances in these populations that we don’t experience in the adult clinical research community. When you engage a child for participation in a clinical research program, you are engaging the entire family. Parents have a different risk/benefit profile for their child than they do for themselves. Navigating this complex environment with compassion, integrity and processes that embed compliance into every interaction are critical to protecting this vulnerable population and ensuring we can bring the best treatments forward as quickly as possible. Whether you're just getting started in pediatric clinical research or you have decades of experience, this program is designed to elevate your understanding and application across the regulatory environment, informed consent and assent, recruitment and retention, feasibility, budgeting, contracting and financial management with compliance tips and tricks along the way. Our goal with this interactive conference is to share lessons learned from experienced pediatric clinical research professionals but more importantly, understand the challenges or questions each conference attendee is facing and weave content and engaging discussions around those challenges so that each attendee walks away with the knowledge and the tools they need most.

This conference provides attendees with new information, management tools, and real life examples, to help participants navigate the evolving landscape of pediatric research.

Objective: The goal will be accomplished through lecture and practical application facilitated by clinical research professionals. Information will be presented and discussed regarding the administration of clinical trials according to FDA Regulations and International Council on Harmonisation (ICH) guidance regarding vulnerable populations in clinical research.

Learning Objectives: Upon completion of this (full) course the attendee should be able to:

• Discuss ethical considerations when conducting clinical research in the pediatric population
• Discuss ways in which sites can improve engagement for families by defining tactics to educate and promote research participation
• Discuss guidelines to writing research informed consent and assent documents
• Discuss ways a research nurse can review a protocol for feasibility and help to set reasonable expectations for the potential patient population
• Discuss the pediatric drug development process from an industry perspective
• Discuss how to adequately review the protocol and source documents, list the documentation needed, discuss how to identify obstacles that may occur and the importance of communication amongst the study teams
• Discuss special considerations for developing pediatric research study budgets including a review of "hidden costs"
• Discuss monitoring and auditing issues specific to pediatric research
• Discuss the role and importance for external monitoring and methods safety issues are identified and managed during drug development and post marketing of new medications
• Discuss the compliance challenges associated with conducting clinical trials and one site’s strategy to address this challenge
• Discuss the potential role of pediatric clinical research networks in accelerating the development of pediatric therapeutics