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 webbased 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.

Web-based documentation system with exchange of DICOM RT for multicenter clinical studies in particle therapy

“…Our solution differs from other systems, which only manage and organize patient treatment 10, 11 and other numerous approaches only documenting a single clinical study electronically. [12][13][14][15] Up to today, it is complex and time-consuming to run clinical studies with a large patient group and a multicenter structure, because of the amount and heterogeneity of data as well as the different ways of documenting in different formats within participating institutions. Especially in the field of radiation oncology, one must deal with distributed data in various information systems.…”