Abstract
The INternational VErapamil SR/trandolapril STudy (INVEST) is the first long‐term, large‐scale clinical trial being conducted primarily using Web‐based technology. The Web is a powerful tool for enhancing clinical trial management because of its ability to centralize all study information and coordinate multiple trial processes in real time at lower cost. The result is improved efficiency, accuracy, and safety in clinical trials conduct. In Web‐based clinical trials, sites are able to focus primarily on medicine and science, rather than on trial administration. Site training, study documentation, subject recruitment, randomization, medication dispensing, and management procedures are simplified by using Web‐based software to enhance processes. This paper summarizes the advantages achieved for INVEST investigators, sponsor representatives, monitors, and subjects resulting from the centralization and coordination of multiple tasks through Web‐based technology.
Keywords: clinical trials management, Internet, INVEST
Full Text
The Full Text of this article is available as a PDF (793.6 KB).
References
- 1. Keim E., Sippel H., Eich HP, Ohmann C., Collection of data in clinical studies via internet. Stud Health Tech Inform 1997; 43: 57–60 [PubMed] [Google Scholar]
- 2. Workman R., Beatty E., Workman D., Internet based data collection and analysis. Stud Health Tech Inform 1998; 51: 182–186 [PubMed] [Google Scholar]
- 3. Marks RG, Conlon M., Ruberg SJ, Paradigm shifts in clinical trials enabled by information technology. Stat Med 2001; 20: 2683–2696 [DOI] [PubMed] [Google Scholar]
- 4. Cooper‐DeHoff R., Hanberg EM, Heissenberg C., Johnson K., Electronic prescribing via the internet for a coronary artery disease and hypertension megatrial. Clin Cardiol 2001: 24 (suppl 5): V‐14–V‐16 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5. Pepine CJ, Handberg‐Thurmond E., Marks RG, Conlon M., Cooper‐DeHoff R., Volkers P., Zellig P., Rationale and design of the International Verapamil SR/Trandolapril Study (INVEST): An internet‐based randomized trial in coronary artery disease patients with hypertension. J Am Coll Cardiol 1998; 32: 1228–1227 [DOI] [PubMed] [Google Scholar]
- 6. Dorman K., Saade G. R., Smith H., Moise KJ, Use of the World Wide Web in research: Randomization in a multicenter clinical trial of treatment for twin‐twin transfusion syndrome. Obstet Gynaecol 2000; 96: 636–639 [DOI] [PubMed] [Google Scholar]
- 7. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico. GISSI‐3: Effects of lisinopril and transdermal glyceryl trinitrate singly and together on 6‐week mortality and ventricular function after acute myocardial infarction. Lancet 1994; 343: 1115–1122 [PubMed] [Google Scholar]
- 8. Santoro E., Nicolis E., Franzosi MG, Tognoni G., Internet for clinical trials: Past, present, and future. Controlled Clin Trials 1999; 20: 194–201 [DOI] [PubMed] [Google Scholar]
- 9. Kiuchi T., Ohashi Y., Konishi M., Bandai Y., Kosuge T., Kakizoe T., A world wide web‐based user interface for data management systems for use in multi‐institutional clinical trials: Development and experimental operation of an automated patient registration and random allocation system. Controlled Clin Trials 1996; 17: 476–493 [DOI] [PubMed] [Google Scholar]
- 10. Conti RC, Cooper‐DeHoff R., How will INVEST and other hypertension trials change clinical practice? Clin Cardiol 2001: 24 (suppl 5): V‐24–V‐29 [DOI] [PMC free article] [PubMed] [Google Scholar]