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Quantitative Assessment of the Benefits of Specific Information Technologies Applied to Clinical Studies in Developing Countries

Clinical studies and trials require accessibility of large amounts of high-quality information in a timely manner, often daily. The integrated application of information technologies can greatly improve quality control as well as facilitate compliance with established standards such as Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). We have customized and implemented a number of information technologies, such as personal data assistants (PDAs), geographic information system (GIS), and barcode and fingerprint scanning, to streamline a pediatric dengue cohort study in Managua, Nicaragua. Quantitative data was obtained to assess the actual contribution of each technology in relation to processing time, accuracy, real-time access to data, savings in consumable materials, and time to proficiency in training sessions. In addition to specific advantages, these information technologies benefited not only the study itself but numerous routine clinical and laboratory processes in the health center and laboratories of the Nicaraguan Ministry of Health.

Received October 10, 2007. Accepted for publication November 20, 2007.

Acknowledgments: The authors thank Aubree Gordon for technical and statistical support; Danielle Alkov and Nicole Fitzpatrick for excellent editorial assistance; and Samantha Hammond and all the study personnel at the Centro de Salud Socrates Flores Vivas of the Nicaraguan Ministry of Health for their invaluable work on this project.

Financial support: Funding for these studies was provided by the Pediatric Dengue Vaccine Initiative.

^* Address correspondence to Eva Harris, Division of Infectious Diseases, School of Public Health, University of California, Berkeley, 1 Barker Hall #424, Berkeley, CA 94720-7354. E-mail: eharris{at}berkeley.edu

William Avilés and Oscar Ortega contributed equally toward this publication.

Authors’ addresses: William Avilés and Oscar Ortega, Sustainable Sciences Institute, Barrio Monseñor Lezcano, Del portón del Cementerio General, 2 calles al lago, Managua, Nicaragua, Tel/Fax: (505) 254-7266, E-mails: wravmon{at}yahoo.com and oortega_78{at}yahoo.com. Guillermina Kuan, Centro de Salud Socrates Flores Vivas, Ministerio de Salud, Barrio Monseñor Lezcano, Del portón del Cementerio General, 2 calles al lago, Managua, Nicaragua, Tel/Fax: (505) 266-0938, E-mail: drakuan{at}yahoo.com.mx. Josefina Coloma and Eva Harris, Division of Infectious Diseases, School of Public Health, University of California, Berkeley, 1 Barker Hall #424, Berkeley, CA 94720-7354, Tel: (510) 642-4845, Fax: (510) 642-6350, E-mails: colomaj{at}berkeley.edu and eharris{at}berkeley.edu

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				G. Kuan, A. Gordon, W. Aviles, O. Ortega, S. N. Hammond, D. Elizondo, A. Nunez, J. Coloma, A. Balmaseda, and E. Harris The Nicaraguan Pediatric Dengue Cohort Study: Study Design, Methods, Use of Information Technology, and Extension to Other Infectious Diseases Am. J. Epidemiol., July 1, 2009; 170(1): 120 - 129. [Abstract] [Full Text] [PDF]