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Web-based data management for a phase II clinical trial in ALS

Authors: Richard Buchsbaum a;  Petra Kaufmann b;  Alexandra I. Barsdorf b;  Rachel Arbing a;  Jacqueline Montes b;  John L. P. Thompson ab; For The Qals Study Group
Affiliations:   a Department of Biostatistics, Mailman School of Public Health,
b Department of Neurology, College of Physicians and Surgeons, Columbia University, New York, NY, USA
DOI: 10.1080/17482960802378998
Publication Frequency: 6 issues per year
First Published on: 09 September 2008
Subject: Neurology;
Formats available: HTML (English) : PDF (English)
Previously published as: Amyotrophic Lateral Sclerosis and other Neuron Disorders (1466-0822, 1471-180X) until 2006
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Abstract

The objective was to report on the creation, features and performance of a web-based data management system for a two-stage phase II randomized clinical trial of Co-Enzyme Q10 in ALS. We created a relatively comprehensive web-based data system that provided electronic data entry; patient management utilities; adverse event reporting, safety monitoring, and invoice generation; and standardized coding for medications and adverse events. In stage 1, clinical sites submitted 7207 forms reporting on 105 patients followed for 10 months. Less than 0.7% of submitted forms contained errors. At the time of the delivery of the analysis data set, only four errors remained unresolved. Data were available quickly, with a median time from event to data posting of two days. The data set was locked and the analysis data set produced nine days after the final patient visit. A survey of trial personnel yielded generally positive feedback, with 75% of respondents wishing to use a similar system in the future. Given sufficient resources, a comprehensive web-based data management system can meet the need for clean, available data in clinical trials in ALS and similar diseases, and can contribute significantly to their efficient execution.
Keywords: Clinical trial; data management; web; EDC; ALS
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