title: Web-based data management for a phase II clinical trial in ALS.
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.
authors.affiliation: Department of Biostatistics, Mailman School of Public Health, Columbia University, 722 West 168th Street, New York, NY 10032, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Buchsbaum
authors.forename: Petra
authors.initials: P
authors.lastname: Kaufmann
authors.forename: Alexandra I
authors.initials: AI
authors.lastname: Barsdorf
authors.forename: Rachel
authors.initials: R
authors.lastname: Arbing
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Montes
authors.forename: John L P
authors.initials: JL
authors.lastname: Thompson
mesh_terms: D000690:Amyotrophic Lateral Sclerosis / Q000188:drug therapy*; D017322:Clinical Trials, Phase II as Topic; D003628:Database Management Systems; D006801:Humans; D020407:Internet; D010919:Placebos / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic; D014451:Ubiquinone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014815:Vitamins / Q000627:therapeutic use*
chemical_list: D010919:Placebos; D014815:Vitamins; D014451:Ubiquinone; C024989:coenzyme Q10