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Data Standards in Clinical Research: Gaps, Overlaps, Challenges and Future Directions

Pediatrics Epidemiology Center, University of South Florida, Tampa, FL

^_* Correspondence: Rachel L Richesson, PhD, Department of Pediatrics, College of Medicine, University of South Florida, 3650 Spectrum Blvd., Suite 100, Tampa FL (Email: richesrl{at}epi.usf.edu).

Received for publication: 04/03/07; accepted for publication: 08/07/07.

Current efforts to define and implement health data standards are driven by issues related to the quality, cost and continuity of care, patient safety concerns, and desires to speed clinical research findings to the bedside. The President’s goal for national adoption of electronic medical records in the next decade, coupled with the current emphasis on translational research, underscore the urgent need for data standards in clinical research. This paper reviews the motivations and requirements for standardized clinical research data, and the current state of standards development and adoption–including gaps and overlaps–in relevant areas. Unresolved issues and informatics challenges related to the adoption of clinical research data and terminology standards are mentioned, as are the collaborations and activities the authors perceive as most likely to address them.