The Elegant Machine: Applying Technology to Optimize Clinical Trials
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pp. 861469. 1998 Printed in the USA. All rights reserved.
Drug Informarion Journal. Vol. 32,
THE ELEGANT MACHINE: APPLYING TECHNOLOGY TO OPTIMIZE CLINICAL TRIALS WAYNER. KUBICK,BA, MBA Vice President, Information Technology. PAREXEL International Corporation, Waltham, Massachusetts
A new model for conducting clinical research programs in the future is beginning to evolve which will emphasize collaboration, interdependency, and close interactive sharing of information among the various stakeholders in the researchprocess: patient, investigator; sponsor; project manager; medical monitor; data management organization, laboratories, biostatisticians, and regulatory authorities. This model will conserve the use of information by minimizing redundancies, transcriptions, and data conversions in a continuous data flow,simplifying the data clarification process, and using the “bestfit” technology tool for capturing and accessing clinical information. This view of clinical research will be based on a generic data repository based upon evolving International Conference on HarmonizatiodFood and Drug Administration (ICH/FDA) data standards which will also support trials management and safety monitoring with respect to the data repository. The current state of alternative data capture technologies such as interactive voice response systems ( N R S ) , remote data entry (RDE), image recognition, Internet technologies, hand-held computers, voice recognition, and wearable monitoring devices will be reviewed. Key Words: Data management; Electronic data capture (EDC); Optical imaging; Interactive voice response (IVR); Data repository
INTRODUCTION IT IS AXIOMATIC TO STATE that the process of clinical research and development can generally be improved through the proper and prudent application of information technology (IT). All too typically, however, technology implementationsare costly, time~
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Originally presented at the DIA 12th Annual Symposium and Exhibition: “Innovative Technologies and Strategies for the Global Management of Clinical Information,” March 16-29, 1997, Philadelphia, Pennsylvania as “The Elegant Machine: How Technology Can Transform Clinical Data Management.” Reprint address: Wayne R. Kubick, PAREXEL International Corporation, 195 West Street. Waltham, MA 02 154.
consuming, and disappointing. Often this disappointment results from inadequate implementation and insufficient process improvement. In far too many instances, the technology disappoints because it is overly complicated and ambitious-it tries to do too many things at once, and does not do them well enough. In technology-just as in industrial design, fashion, and art-people often find that a simple but powerful solution is the best answer. People admire do-everything, feature-laden software suites, but they are generally more comfortable with a simple, intuitive, and familiar tool that is optimally suited to do the job at hand. In essence, people look for technology solutions that are elegant:
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