Is the future for clinical trials internet-based? A cluster randomized clinical trial
Abstract
Objective To compare the efficiency and ease of use of internet data capture compared with conventional paper based data recording in the conduct of a clinical trial. Design Multicentre, cluster randomized clinical trial. Setting General practice in the UK. Main outcome measures Timings for study landmarks, queries, data entry and monitoring time; Investigator Questionnaire Results. Results The internet-derived database was ready for release 33 days after the last patient visit compared with 48 days for the paper-derived database, despite much higher numbers of patients in the internet group. The mean times from visit to data entry were 10.2 (SD 18.9) days and 95.4 (SD 44.6) days respectively (P, 0.01). The mean times from a visit to a query being resolved were 121.4 (SD 58.3) days and 182.1 (SD 58.9) days respectively (P, 0.01). The post-study responses from investigators were positive. Seventy-one percent of centressaid they would prefer to use the internet rather than paper CRFs for future studies. Conclusions There were efficiency gains seen with the use of an internet-based system when compared with a paper-based system in terms data entry, query resolution and the time to the release of the data base. The investigators'response to the internet system was generally favourable although on average investigators reported increased time spent on the study. Further efficiency might be gained with improved programming, increased investigator familiarity with the internet system, and with newly adapted working practices for sponsors' monitors and database personnel.
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Electronic data collection increases the speed, accuracy, and user acceptability of the process.
“Research has indicated the electronic data collection increases the speed, accuracy, and user acceptability of the process [197–199].”
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- Authors
- Litchfield, J., Freeman, J., Schou, H., Elsley, M., Fuller, R., & Chubb, B.
- Affiliations
- Pound Hill Medical Group, Crawley, West Sussex, UK
- University of Sheffield (GB)
- Novo Nordisk (United Kingdom) (GB)
- Corresponding author
- Schou, Henrik
- ORCID
- Chubb, Barrie
- Venue
- Clinical Trials
- Publisher
- SAGE Publications
- Published
- 2005-02
- Volume
- 2
- Issue
- 1
- Pages
- 72-79
- ISSN
- 1740-7745 (ISSN-L)
- 1740-7753
- OpenAlex
- W2085409301
- Cited by
- 56
- References
- 5
- Citations by year
- 2026: 3 · 2025: 2 · 2024: 2 · 2023: 2 · 2022: 3 · 2021: 6 · 2020: 2 · 2019: 1 · 2018: 2 · 2017: 3 · 2016: 2 · 2015: 2 · 2014: 3 · 2013: 4 · 2012: 2
- FWCI
- 5.59
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Trials (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Health Professions › Health Information Management › Electronic Health Records Systems
- Social Sciences › Sociology and Political Science › Survey Methodology and Nonresponse
- Physical Sciences › Computer Science › Information Systems › Research Data Management Practices
- Keywords
- electronic data capture, clinical trial efficiency, data entry time, query resolution
- MeSH terms
- Clinical Trials as Topic, Data Collection, Database Management Systems, Diabetes Mellitus, Family Practice, Humans, Surveys and Questionnaires, Software, Cluster Analysis, Information Storage and Retrieval, Drug Delivery Systems, Efficiency, Organizational, Information Management, Internet
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