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

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

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