Expert Insights

Expert Insights

Addressing Regulatory Requirements for Pediatric Clinical Trials

Addressing Regulatory Requirements for Pediatric Clinical Trials
29 January 2019

By Dr. Martine Dehlinger-Kremer, Vice President, Pediatric Development at Synteract 

Drug developers can no longer ignore pediatric requirements for new medicines, indications, dosing forms, or dosing regimens. A pediatric development plan is required both in the U.S. and EU, named respectively Pediatric Study Plan (PSP), and Pediatric Investigation plan (PIP). But not every CRO is familiar with the challenges of pediatric developments and pediatric trials, and this should be an important consideration early on for sponsors in selecting partners.

Sponsors need to anticipate the appropriate budget for pediatric development and pediatric trials and plan for this early on in the drug development process. How many trials will be needed? What changes will be made for pediatric formulation? For example, the dosage might need to be a liquid or micro-tablet instead of capsule or larger tablet, and the amount may be different. The excipients must be safe in children. Then the product must be tested with children (palatability test) to see if they will accept it, and like the flavors (which preferences are sometimes different from the U.S. to EU). 

In the United States

  • The initial Pediatric Study Plan (iPSP) is to be submitted to the FDA within 60 days after the date of the end of Phase II meeting.
  • For drugs or biologics intended to treat a serious or life-threatening disease or condition, the iPSP is to be discussed no later than the end of the Phase I meeting or within 30 days of the FDA’s receipt of the request, whichever occurs first.
  • For drugs and biologics subject to the iPSP and in the absence of an end of Phase II meeting, the sponsor should submit the iPSP as early as possible, but before the initiation of any Phase III studies, or any combined Phase II/Phase III studies. 
  • If a Phase III study or a combined Phase II/Phase III study will not be conducted, the sponsor should submit the iPSP no later than 210 calendar days before submitting the marketing application or supplement.  A sponsor should submit the iPSP to its IND for the drug. A sponsor should not submit a marketing application or supplement until agreement has been reached on the iPSP. 

In the EU

  • The Pediatric Investigation Plan (PIP) is to be submitted after pharmacokinetic (PK) studies in adults are completed.
  • Compliance with the agreed PIP is mandatory prior to a marketing authorization application. Non-compliance with the PIP will prevent the validation of the regulatory application.

What are three things drug developers need to know about Clinical Trial Regulation No 536/2014 & pediatric research? Get the latest white paper on this topic.

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