What is a Pediatric Study Plan?

 
 
 
 
 
 
 
 
 
 
 
 

Our May CAC2 All-Member webinar focused on how pediatric cancer study plans are developed.  CAC2 Member Kelli Wright (CureSearch) introduced Dr. Brenda Weigel from University of Minnesota’s Masonic Cancer Center and Dr. Samuel Blackman of Day One Biopharmaceuticals as they addressed:

  • What is a Pediatric Study Plan (PSP)?
  • How is it created and by who?
  • How does FDARA/RACE for Children impact PSP development?
  • Where in the process are the opportunities to create better PSPs?

What is a Pediatric Study Plan?  A Glimpse into the Process of Pediatric Cancer Study Plan Development (click to view)

Currently, regulatory agencies require that a pharmaceutical or biotechnology company submit a Pediatric Study Plan (PSP) to confirm the suitability of drug usage in the pediatric population and move forward in creating clinical trials for children’s therapies. Successful plan development requires pediatric expertise via collaboration between industry and academia, yet that collaboration is often lacking.

The RACE for Children Act/FDARA, slated to go into effect on August 18, 2020, will bring additional requirements to PSP development, making it critical and timely that trial sponsors consider pediatric implications earlier in the drug development process.

 

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