Publications by authors named "Forrest Williamson"
Ther Innov Regul Sci
November 2022
Article Synopsis
- Master protocols are advanced clinical trial designs that enhance analytics and operations, aimed at benefiting both patients and drug developers, but their use in pediatric drug development has primarily been limited to oncology.*
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- The article discusses how master protocols can facilitate pediatric drug programs mandated by the FDA and EMA, allowing for the use of adult trial data to inform pediatric efficacy and safety in small populations.*
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- Janssen and Lilly are collaborating on a pediatric platform trial for Crohn's disease using Bayesian analysis, emphasizing the advantages of a unified study framework to expedite drug approvals and increase access to effective treatments for children.*
