Evaluation of the fragility of pivotal trials used to support FDA approval for plaque psoriasis

Abstract:

Over the last half decade, there has been a significant growth in FDA approvals of systemic therapies with indications for psoriasis. In this study we evaluated the fragility of data used to suport pivotal trials for these approvals. In doing so, we reviewed primary efficacy endpoints of all systemic medications with a labeled indication for plaque psoriasis available from Drugs@FDA. We found that 69 clinical trial primary endpoints met our criteria for inclusion and were assessed for robustness. The median fragility index (MFI) was determined to be 72 and the median fragility quotient (MFQ) was 0.19.

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Sophia Shalhout
Cutaneous Oncology Research Fellow

My research interests include clinical and translational research in advanced skin cancers.

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