An analysis by US Food and Drug Administration (FDA) officials published earlier this month finds that there is a similar success rate for pediatric pivotal trials relying on surrogate endpoints ...

Visit NAP.edu/10766 to get more information about this book, to buy it in print, or to download it as a free PDF. Accelerated approval—regulatory mechanism by which new drugs meant to treat serious, ...

A few months back, good news hit the multiple myeloma community: the U.S. Food & Drug Administration voted to accept a new endpoint — MRD, or measurable residual disease — for accelerated approval of ...

Most pivotal clinical trials supporting the accelerated approval of nononcology products reported surrogate measures as primary endpoints, according to a recent research letter published in JAMA. Ian ...

Minimal residual disease was “strongly” associated with overall survival at the patient level, researchers reported. Minimal residual disease (MRD) is “a credible intermediate endpoint” for some ...

Substantive data now support albuminuria change as a surrogate for a kidney failure endpoint in trials of drugs that affect albuminuria, across CKD etiologies. Albuminuria change can serve as a ...