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


METHODS
Multicentre, cluster randomized clinical trial.


METHODS
General practice in the UK.


METHODS
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 centres said 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 database. 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.
Litchfield
Jennifer
J
Poland Hill Medical Group, Crawley, West Sussex, UK.
Freeman
Jenny
J
Schou
Henrik
H
Elsley
Mark
M
Fuller
Robert
R
Chubb
Barrie
B
D002986:Clinical Trials as Topic / Q000379:methods* / Q000639:trends; D016000:Cluster Analysis; D003625:Data Collection / Q000379:methods*; D003628:Database Management Systems; D003920:Diabetes Mellitus / Q000188:drug therapy; D016503:Drug Delivery Systems; D017598:Efficiency, Organizational; D005194:Family Practice; D006801:Humans; D019451:Information Management / Q000379:methods*; D016247:Information Storage and Retrieval; D020407:Internet / Q000639:trends; D012984:Software; D011795:Surveys and Questionnaires