The JAMA Pediatrics journal 2019 reports the increasing prevalence of pediatric chronic disease that has resulted in increased exposure to long-term drug therapy in children. The duration of recently completed drug trials that support approval for drug therapy in children with chronic diseases has not been systematically evaluated. Such information is a vital first step in forming safety pharmacovigilance strategies for drugs used for long-term therapy in children.
Pediatric clinical trials designed to sufficiently investigate drug safety and efficacy to support FDA approval are of relatively limited duration. Given the potential long-term exposure of patients to these drugs, the clinical community should consider whether new approaches are needed to better understand the safety associated with long-term use of these drugs.
In this scenario It takes a lot of experience in the field to set up and manage pediatric clinical trials, and that’s what moved OPIS to assist its clients with solutions where all stakeholders can work together towards making trial participation as friendly as possible.
OPIS services dedicated to pediatric trials are:
- Regulatory Consulting
- Regulatory Agency Liaison (FDA, EMA, PDCO, etc.)
- Pediatric Study Plan Development and Submission
- Pediatric Investigation Plan Development and Submission