Design of Controlled Clinical Trials for Diabetic Polyneuropathy

Ander A. F. Sima; Charles Laudadio

doi:10.1055/s-2008-1040975

Seminars in Neurology, Table of Contents

Semin Neurol 1996; 16(2): 187-191
DOI: 10.1055/s-2008-1040975

Design of Controlled Clinical Trials for Diabetic Polyneuropathy

Ander A.F. Sima, Charles Laudadio

Department of Pathology, Wayne State University and Detroit Medical Center, Detroit, Michigan (A.A.F.S.), and Department of Pharmacology, University of Delaware and the Medical Center of Delaware, Newark, Delaware (C.L.)

Abstract

ABSTRACT

Diabetic neuropathy is a common and debilitating complication of diabetes mellitus associated with high health costs. In recent years several clinical trials have been undertaken to test the efficacy of drug intervention in this disorder. The results of these trials have in general been disappointing. In this review we discuss selection criteria, efficacy endpoints, duration of clinical trials, and data collection and analyses. We offer suggestions based on past experiences that might improve trial design and execution in order to achieve improved results from treatment of this silent but common disorder.

Keywords

diabetic neuropathy - drug efficacy - clinical trial designs

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