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Published on: September 20, 2019
Web-based data management for a phase II clinical trial in ALS.
Richard Buchsbaum1, Petra Kaufmann, Alexandra I Barsdorf
1Department of Biostatistics, Mailman School of Public Health, Columbia University, 722 West 168th Street, New York, NY 10032, USA.
Summary
A web-based data system streamlined a clinical trial for Co-Enzyme Q10 in Amyotrophic Lateral Sclerosis (ALS), ensuring accurate and timely data collection with minimal errors.
Area of Science:
- Clinical Informatics
- Neurology
- Pharmaceutical Science
Background:
- Amyotrophic Lateral Sclerosis (ALS) clinical trials require robust data management.
- Traditional data collection methods can be time-consuming and prone to errors.
Purpose of the Study:
- To report on the development and performance of a web-based data management system.
- To evaluate the system's efficiency in a two-stage phase II clinical trial for Co-Enzyme Q10 in ALS.
Main Methods:
- Development of a comprehensive web-based system with electronic data entry and patient management.
- Implementation of adverse event reporting, safety monitoring, and standardized coding.
- Utilized the system in a two-stage phase II randomized clinical trial.
Main Results:
- Over 7000 forms submitted with less than 0.7% errors.
- Data available rapidly, with a median of two days from event to posting.
- Trial personnel provided positive feedback, with 75% willing to use the system again.
Conclusions:
- A well-resourced web-based data management system effectively supports clean and accessible data in ALS trials.
- Such systems significantly enhance the efficiency of clinical trial execution.
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