1. Pink Sheet

Don’t Stop Translational Research Once You Move To Clinic, US FDA Tells Sponsors

 
• By Sarah Karlin-Smith

Drug developers often discontinue translational research as they move into late phase clinical studies – a move that can come back to haunt them, particularly if they want to rely on such data for confirmatory evidence, said Office of New Drugs Director Peter Stein.

Two train tracks running parallel to each other
Translational research should proceed on parallel tracks with pivotal studies for best shot in using as confirmatory evidence. • Source: Shutterstock

Sponsors should consider continuing translational science in parallel with their pivotal clinical trials, particularly if they may want to rely on that science as confirmatory evidence to meet the US Food and Drug Administration’s effectiveness standard, Peter Stein, FDA’s Center for Drug Evaluation and Research Office of New Drugs director, said.

Stein raised the issue due to concerns that a lack of this research is hurting new drug applications. 

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