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Is the future for clinical trials internet-based? A cluster randomized clinical trial
Jennifer Litchfield1, Jenny Freeman, Henrik Schou
1Poland Hill Medical Group, Crawley, West Sussex, UK.
Clinical Trials (London, England)
|November 11, 2005
Summary
Internet data capture in clinical trials significantly improves efficiency over paper-based methods. This digital approach accelerates data entry, query resolution, and database release, making clinical trial management faster.
Area of Science:
- Clinical trial methodology
- Health informatics
- Data management
Background:
- Traditional paper-based data recording in clinical trials can be time-consuming and inefficient.
- Assessing the efficiency and usability of newer technologies is crucial for optimizing clinical trial conduct.
Purpose of the Study:
- To compare the efficiency and ease of use of internet data capture versus conventional paper-based data recording in clinical trials.
- To evaluate the impact of data capture methods on study timelines and investigator workload.
Main Methods:
- A multicentre, cluster randomized clinical trial was conducted in UK general practices.
- Key outcome measures included timings for study landmarks, query resolution, data entry, and monitoring time, alongside investigator questionnaire results.
Main Results:
- Internet data capture resulted in a faster database release (33 days vs. 48 days) and significantly quicker data entry (10.2 days vs. 95.4 days) and query resolution (121.4 days vs. 182.1 days).
- Despite reporting increased time spent on the study, 71% of investigators preferred internet-based data capture for future trials.
Conclusions:
- Internet-based systems offer significant efficiency gains in clinical trial data management, including data entry, query resolution, and database release.
- Investigator feedback was generally favorable, suggesting potential for further improvements with enhanced system familiarity and adapted working practices.