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Published on: September 20, 2018
Data standards in clinical research: gaps, overlaps, challenges and future directions
Rachel L Richesson1, Jeffrey Krischer
1Department of Pediatrics, College of Medicine, University of South Florida, 3650 Spectrum Blvd., Tampa, FL, USA. richesrl@epi.usf.edu
Implementing health data standards is crucial for improving care quality, patient safety, and accelerating clinical research. This paper examines the need for, and current state of, standardized clinical research data.
Area of Science:
- Health Informatics
- Clinical Research
- Data Standards
Background:
- Efforts to standardize health data are driven by needs for better care quality, cost-efficiency, patient safety, and faster clinical research.
- National goals for electronic medical records adoption and translational research highlight the urgency for clinical data standards.
Purpose of the Study:
- To review the motivations and requirements for standardized clinical research data.
- To assess the current landscape of clinical research data standards development and adoption, identifying gaps and overlaps.
Main Methods:
- Literature review of current health data standards initiatives.
- Analysis of existing standards development and adoption in clinical research.
- Identification of informatics challenges and potential solutions.
Main Results:
- Significant progress exists in health data standardization, driven by clinical and research needs.
- Gaps and overlaps in current standards necessitate further development and harmonization.
- Informatics challenges remain a barrier to widespread adoption.
Conclusions:
- Standardized clinical research data are essential for advancing healthcare quality and translational science.
- Addressing identified gaps, overlaps, and informatics challenges requires collaborative efforts.
- Continued development and adoption of robust data standards are critical for future healthcare innovation.
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