Telecommunication technology for the management of large scale clinical trials: The Gissi experience

Computer Methods and Programs in Biomedicine

Volumn 60, Issue 3, 1999, Pages 215-223

  Santoro, Eugenio ^a   Nicolis, Enrico ^a   Grazia Franzosi, Maria ^a  

^a Ist Ricerche Farmacol Mario Negri   (Italy)

Author keywords

Clinical trials; Communication; Computerized data collection; GISSI, Randomization algorithm; Randomization; Telecommunication

Indexed keywords

ALGORITHMS; DATA ACQUISITION; DATA COMMUNICATION SYSTEMS; MANAGEMENT INFORMATION SYSTEMS; QUERY LANGUAGES;

RANDOMIZATION ALGORITHM;

MEDICAL COMPUTING;

LISINOPRIL;

ARTICLE; CLINICAL TRIAL; COMPUTER NETWORK; CORONARY CARE UNIT; DIAGNOSTIC ACCURACY; ECONOMIC ASPECT; HUMAN; INFORMATION PROCESSING; ITALY; MICROCOMPUTER; MULTICENTER STUDY; TECHNOLOGY; TELECOMMUNICATION;

ALGORITHMS; CLINICAL TRIALS; COMPUTER COMMUNICATION NETWORKS; HUMANS; INTERNET; ITALY; MULTICENTER STUDIES; RANDOM ALLOCATION; RESEARCH DESIGN; SOFTWARE; TELECOMMUNICATIONS;

EID: 0032887170     PISSN: 01692607     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0169-2607(98)00108-4     Document Type: Article

References (19)

1. McFadden E.T., LoPresti F., Bailey L.R., Clarke E., Wilkins P.C. Approaches to data management. Controlled Clin. Trials. 16:1995;30S-65S.
2. Naydeck B.L., Sutton-Tyrrell K., Burek K., Sopko G.S. Organizational structure and communication strategies of the bypass angioplasty. Revascularization investigation: a multicenter clinical trial. Controlled Clin. Trials. 17:1996;226-234.
3. Sutton-Tyrrell K., Crow S., Hankin B., Trudel J., Faille C. Communication during the recruitment phase of a multicenter trial: the recruitment hotline. Controlled Clin. Trials. 17:1996;415-422.
4. K. Getz, The Internet-tapping into patient recruitment. Scrip Magazine April (1996) 28-31.
5. S.J. Pocock, Clinical trials: a practical approach. Wiley (ed.), (1989) Avon.
6. GISSI-3 Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico. GISSI-3 study protocol on the effects of lisinopril, of nitrates, and of their association in patients with acute myocardial infarction. Am. J. Cardiol. 70 (1992) 62C-69C.
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 343 (1994) 1115-1122.
8. Santoro E., Franzosi M.G., Nicolis E. A computerized network system for the management of a large scale multicentre clinical trial: the GISSI-3 trial. Controlled Clin. Trials. 14:1993;430.
9. Collaborative Organization for Rheothrx Evaluation (CORE). Effects of rheothrx on mortality, morbidity, left ventricular function and infarct size in patients with acute myocardial infarction, Circulation 96 (1997) 192-201.
10. Santoro E., Nicolis E., Franzosi M.G. Randomization systems in an international multicentre clinical trial: the CORE study. Controlled. Clin. Trials. 17:1996;91S.
11. GISSI Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico.Protocollo dello studio GISSI-Prevenzione. Studio di intervento preventivo sulle componenti aterosclerotica e trombotica del rischio post-infarto. G. Ital. Cardiol. 23 (1993) 1053-1061.
12. Lange N., MacIntyre J. A computerized patient registration and treatment randomization system for multi-institutional clinical trials. Controlled Clin. Trials. 6:1985;38-50.
13. Krischer J.P., Hurley C., Pillalamarri M., Pant S., Bleichfeld C., Opel M., Shuster J.J. An automated patient registration and treatment randomization system for multicenter clinical trials. Controlled Clin. Trials. 12:1991;367-377.
14. Assmann S.F., Bodnya A., Staples Smith S., Tighe F. An interactive voice response system for randomizing patients. Controlled Clin. Trials. 17:1996;68S.
15. McPherson J.A., Knuth T.R. Use of oracle with an interactive voice response system (IVR) to randomize patients in an acute controlled clinical trial. Controlled Clin. Trials. 17:1996;69S.
16. Zadnik K., Bullimore M.A., Barr J.T., Gordon M.O., Edrington T.B. Collaborative Longitudinal Evaluation in Keratoconus (CLEK) Study. Recruitment for a large-scala clinical study via the internet. Controlled Clin. Trials. 17:1996;45S.
17. Carr S., Foster V., Wiener M., Blagg A. Exploring the information superhighway: the use of the internet in clinical drug trials. Controlled Clin. Trials. 17:1966;44S.
18. Singer S.W., Newhouse M.M., Otero D.T. Format-independent data collection forms, the world-wide web, and reusable research data management: a proposal. Controlled Clin. Trials. 17:1996;47S.
19. Applying the internet to clinical data management. Scrip Magazine Sept (1996) 58-60.