Dual Energy X-Ray Absorptiometry (DXA) Transmission Methodology in Clinical Trials
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DUAL ENERGY X-RAY ABSORPTIOMETRY (DXA) TRANSMISSION METHODOLOGY IN CLINICAL TRIALS COLING. MILLER,BSc, PHD Director of Clinical Services, Bona Fide, Ltd.. Madison, Wisconsin
ANTHONYA. LYONS,FRCS(ED) Lecturer, Orthopaedic Surgery, Queen’s Medical Centre, Nottingham. United Kingdom
DAVIDW. PYE, BSc, PHD Principal Physicist, Queen’s Medical Centre, Nottingham, United Kingdom
MANDYBLAZE,BSc DXA Technologist, Queen’s Medical Centre, Nottingham. United Kingdom
GRACEA. FASANO, BS, CNMT Clinical Instrumentation Specialist. Bona Fide, Ltd.. Madison, Wisconsin
SIMONE HORNEYE,BS Clinical Instrumentation Associate, Bona Fide, Ltd., Madison, Wisconsin
Dual Energy X-Ray Absorptiometry (DXA) has become the “gold standard” technique for the assessment of bone mineral density (BMD).More recently, this type of trial data has been handled by specialist quality assurance (QA) centers partly at the recommendation of regulatory agencies. The data are generally transmitted via paper and/or diskette from the site to the QA centex The aims of this study were to test the feasibility of transmitting these types of image files of about 8OkBytes from the investigator site to the QA center directly via modem. One hundred sixty images and related data were transmitted transatlantically, without error and at a lower cost than using conventional methodologies. The time from patient DXA scan to QA review was also significantly shortened, thereby improving data quality further: Key Words: Data transfer; DXA; Bone mineral density; Orthopedics; Clinical trials
INTRODUCTION PATIENT DATA COLLATION and collection in clinical trials can be a rate-limiting step in any drug development process. The aim of having data collected and in-house as Reprint address: Dr.Colin G. Miller, PhD, Bona Fide Ltd., 313 West Beltline Highway, Madison, WI 53713.
rapidly as possible has become the goal of every major pharmaceutical company in an effort to reduce drug development time (1). Dual Energy X-Ray Absorptiometry has become the “gold standard” technique for the assessment of bone mineral density (2). It is also becoming the standard meansbf assessment of M y composition in obesity duetion trials. In recent years this type of trial
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C. G.Miller, A. A. Lyons, D. W. Pye, M. Blaze, G. A. Fasano, and J. Horneye
data has been increasingly handled by specialist quality assurance centers such as Bona Fide, Ltd. This is the methodology recommended by most regulatory agencies (3,4,5). The data are generally sent on paper andor on diskette from the site to the QA center at regular but possibly wide time intervals. Good clinical practice (GCP) dictates that electronic data collection requires validated software and error free transmission (6). A complete review of the DXA data should also be performed “out of house” unless the monitoring organization has personnel with the approp
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