The use of handheld computers in clinical trials.
A recently completed, randomized, double-blind placebo-controlled clinical trial is presented in which Palm handheld computers were used as a substitute for normal paper-based patient diaries. In this nasal provocation study, a common antihistamine approved for the treatment of seasonal allergic rhinitis was tested against placebo for evidence of additional properties. In addition to their medical examinations, the 12 study volunteers rated subjective complaints in a diary program on 4 examination days, for a duration of 4.5 hours every 15 minutes at each visit. This resulted in 903 data sets consisting of five questions each, or 4515 data points total. In this study the use of handheld computers resulted in an increase in data quality and shortened the time needed to close the database. Moreover, the benefit of electronic reminders for protocol compliance is clearly demonstrated. Our findings support the results found in the literature we reviewed. For more than 16 years, mobile computers have been supporting the implementation of clinical trials. Our review of 27 articles out of more than 100 clinical trials in which mobile computers have been used elaborates on the advantages and problems of this technology. We give a comprehensive overview of the various technologies as used in different settings, and then discuss the methodology of using mobile devices in comparison to traditional methods, the considerations that need to be made and things to be avoided in order to conduct a successful clinical trial with mobile tools. We conclude that mobile devices are very useful in most cases, especially when design and software validation aspects have been taken into account.
Koop
Andreas
A
Institute for Medical Statistics, Informatics, and Epidemiology, University of Cologne, Cologne, Germany. Andreas.Koop@medizin@uni-koeln.de
Mösges
Ralph
R
D000328:Adult; D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003625:Data Collection / Q000295:instrumentation*; D016208:Databases, Factual; D004311:Double-Blind Method; D006801:Humans; D008432:Mathematical Computing; D008499:Medical Records / Q000706:statistics & numerical data*; D008838:Microcomputers; D015508:Nasal Obstruction / Q000188:drug therapy*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D012986:Software Validation; D016593:Terfenadine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*
D018926:Anti-Allergic Agents; D016593:Terfenadine; C093230:fexofenadine