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Is the future for clinical trials internet-based? A cluster randomized clinical trial

Pound Hill Medical Group, Crawley, West Sussex, UK

Jenny Freeman

Institute of General Practice & Primary Care, University of Sheffield, Sheffield, UK

Henrik Schou

Clinical Research Department, Novo Nordisk Limited, Crawley, West Sussex, UKhscu{at}novonordisk.com

Mark Elsley

Robert Fuller

Barrie Chubb

Clinical Research Department, Novo Nordisk Limited, Crawley, West Sussex, UK

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.

Clinical Trials, Vol. 2, No. 1, 72-79 (2005)
DOI: 10.1191/1740774505cn069oa


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