“In some circumstances, these covariates may be known from the scientific literature. In other cases, it may be useful to use previous studies (e.g., a Phase II trial) to select prognostic covariates or form prognostic indices.”
One such innovative application of the guidance is the use of composite covariates such as Placebell, a placebo prognostic covariate developed by Cognivia.
Join this exclusive webinar to explore the latest FDA guidelines and the remarkable benefits of using prognostic covariates to enhance trial accuracy and improve assay sensitivity while complying with regulatory requirements. With a decade of experience developing prognostic covariates and assisting sponsors with adjustments, Cognivia will help you translate this critically important FDA guidance into practical recommendations for your next trial. The featured speakers will also delve into concrete applications of composite prognostic covariates.
Join experts from Cognivia, Samuel Branders, Data Mining Scientist Director; and Hervé Pagès, Customer Solution Director, for the live webinar on Wednesday, September 6, 2023, at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit Covariate Adjustment in Randomized Clinical Trials Based on Latest FDA Guidance: Application to Composite Covariates.
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