New IBD safety registry established to support the completion of post-marketing safety requirements
Reviewed by Emily Henderson, B.Sc.Nov 6 2020
The Pediatric IBD Foundation, ImproveCareNow, and the Critical Path Institute (C-Path) are proud to announce a collaboration establishing the Children's Registry for the Advancement of Therapeutics (CREATE™).
CREATE™ is a drug-agnostic safety registry designed to support the completion of global post-marketing safety requirements, as well as collect safety information on all therapies used in pediatric IBD patients.
CREATE™ will facilitate collaboration between multiple industry sponsors to advance the development of the safety monitoring registry. Stakeholders contributing to the implementation of CREATE™ include universities, hospitals, health care providers, learning health networks, community organizations, the pharmaceutical industry and government agencies.
With the endorsement and support of the IBD community, CREATE™ brings together key groups to advance new ideas in IBD treatment and safety.
We are excited to partner with the Pediatric IBD Foundation and ImproveCareNow on this initiative," CREATE™ promotes collaboration and the safe data sharing processes that have long been needed to advance pediatric IBD treatments."
Joseph Scheeren, Pharm.D.,C-Path President and CEO,
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The three partnering organizations will advance development of a post-marketing safety monitoring registry by jointly developing operational and business models aimed to gain the endorsement and support of pharmaceutical companies and regulatory agencies.
"With support of pediatric gastroenterologists, patients and families, to develop tools and processes and roll out strategy among pediatric GI sites for a regulatory compliant pediatric IBD safety registry, the capturing of important safety information for all therapies used in pediatric IBD patients will be realized," said PIBDF Board Chair Eric Zuckerman, D.O.
"Progress does take time but the spirit of collaboration is always critical to advancement of new ideas. The time is now to accelerate these plans for children with inflammatory bowel disease."
"Establishment of long-term safety registry is the need of the hour, as increasing number of biologic therapies become available for treatment of pediatric onset inflammatory bowel diseases," said ImproveCareNow Clinical Director Shehzad Saeed, M.D., F.A.A.P., A.G.A.F.
"Collaboration between the relevant stakeholders is the key for realizing this important step. The ImproveCareNow community looks forward to this collaboration."