Pediatrics
Unique challenges and complexities of pediatric clinical trials explored.
Identifying and mitigating risks in pediatric protocol development:
Strategies, tools & access planning
In this webinar, presenters will explore the regulatory strategies and tools needed to ensure pediatric access to medical treatment, focusing on Pediatric Investigation Plans (PIPs) and Pediatric Study Plans (PSPs), which are key components in aligning pediatric and adult treatment pathways.
The webinar will also introduce the Pediatric Risk Assessment Map (PRAM), an interactive, reusable tool developed by ICON’s Centre for Pediatric Clinical Development (CPCD).
Pediatric Risk Assessment Map
The Pediatric Risk Assessment Map is an interactive, reusable, and shareable tool that helps to identify common risks that exist in clinical trials that include pediatric patients and offers mitigation strategies for consideration.
The RACE for Children Act
Pediatric cancer is the leading cause of death by disease in the US. The intent of the RACE for Children Act is to get more pediatric oncology drugs in the pipeline.
Pediatrics podcasts
Designing successful pediatric clinical trials
Dr Jacqui Whiteway, Senior Director, Centre for Pediatric Clinical Development took part in this ACRO’s Good Clinical Podcast episode (S2: E4 ) 'Pediatric Clinical Trials: Compassion in Action' to discuss how industry can make participation in pediatric clinical trials easier for pediatric patients and their families.
Removing Barriers to Pediatric Clinical Trials
In this on- demand Podcast. Dr Jacqui Whiteway, Senior Director, Centre for Pediatric Clinical Development discusses something very important to her, ‘Removing Barriers to Pediatric Clinical Trials and how creating positive experiences and reducing anxiety for children in clinical trials can benefit the pediatric trial eco system’. Listen to find out more.
Pediatrics media contributions and blogs
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Blog: A framework for pediatric HRQoL selection: Evaluating the PedsQL™
This article outlines a practical framework for selecting a pediatric HRQoL instrument and applies that framework to the Pediatric Quality of Life Inventory™ (PedsQL™).
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Blog: Mechanism of action in pediatric research
Discover how EMA’s proposed MoA-based PIP requirements mirror the US RACE for Children Act and how sponsors can prepare for pediatric regulatory changes.
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Media article: Fights over Tylenol, SSRIs highlight the enduring lack of pregnant women in drug trials
Read the article to learn why the exclusion of pregnant women from clinical trials continues to fuel data gaps, misinformation, and missed opportunities for safer, more effective treatments.
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Blog: Navigating Pediatric Drug Development (PDP) in Canada: A comprehensive guide part 2
In the previous blog of this series, we introduced the pilot PDP initiated by Health Canada including the types of PDP that can be submitted and the content and format of a C-PDP. This blog discusses the review of PDPs by Health Canada, amending agreed-to PDPs and annual reporting requirements.
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Blog: Navigating Pediatric Drug Development (PDP) in Canada: A comprehensive guide part 1
Health Canada is taking steps to increase data availability to help health care providers by piloting a program for PDPs. In our series we review it & provide guidance.
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Blog: Designing clinical trials for a complex disease: Pediatric obesity
Pediatric obesity is a complex disease with multiple factors for sponsors to consider when designing and executing treatment trials.
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Media article: ACRO Good Clinical Podcast: Paediatric clinical trials: Compassion in action
Jacqui Whiteway participates in this discussion on what makes paediatric clinical trials unique and how the industry can make participation easier for paediatric patients and their families.
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Media article: Paediatric clinical trials for obesity treatment
In this article, ICON experts Alan Baldridge and Heather Peterson discuss the prevalence of paediatric obesity and assess clinical trials of its treatments.
Pediatrics services
ICON is invested in bringing safe, effective, pediatric-tested treatments to children. Explore our pediatric experience and how we can support your study from early engagement all the way to approval.