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Where Art Thou O treatment for diabetic neuropathy: the sequel
This article challenges the rationale for the FDA insisting on symptoms/signs and nerve conduction as primary endpoints for clinical trials in DPN.EXPERT OPINION: Quantitative sensory testing, intraepidermal nerve fiber density, and especially corneal confocal microscopy remain an after-thought, demoted at best to exploratory secondary endpoints in clinical trials of diabetic neuropathy. If pharma are to be given a fighting chance to secure approval for a new therapy for diabetic neuropathy, the FDA needs to reassess the evidence rather than rely on 'opinion' for the most suitable endpoint(s) in clinical trials of diabetic...
Source: Expert Review of Neurotherapeutics - August 21, 2023 Category: Neurology Authors: Yigit Can Guldiken Ayesha Malik Ioannis N Petropoulos Hoda Gad Einas Elgassim Iuliia Salivon Georgios Ponirakis Uazman Alam Rayaz A Malik Source Type: research
