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Achieving standardized medication data in clinical research studies: two approaches and applications for implementing
Rachel L Richesson1, Susan B Smith, Jamie Malloy
1Department of Pediatrics, University of South Florida, Tampa, FL, USA. richesrl@epi.usf.edu
Journal of Medical Systems
|August 13, 2010
Summary
This study explores implementing RxNorm, a standard for clinical drugs, in diverse research settings. It details RxNorm
Area of Science:
- Clinical Informatics
- Health Services Research
- Biomedical Data Standards
Background:
- The National Institutes of Health (NIH) proposed a clinical research roadmap emphasizing data management, harmonization, and standards.
- RxNorm was established in 2003 as a standard for coding clinical drugs, but implementation guidance is limited.
- Clinical research, including epidemiological studies and clinical trials, has varied requirements for data standards and tools.
Purpose of the Study:
- To evaluate the suitability and implementation requirements of RxNorm for different clinical research contexts.
- To provide insights from selecting and implementing RxNorm in both epidemiological and intervention studies.
- To offer guidance for researchers using RxNorm to meet diverse study needs.
Main Methods:
- Reviewed the NIH roadmap for clinical research and its components.
- Analyzed the specific requirements of two distinct clinical research projects: an epidemiological study and an intervention trial.
- Assessed the applicability of RxNorm as a medication standard for each project type.
- Detailed the application and process requirements for RxNorm implementation in these studies.
Main Results:
- Epidemiological studies and clinical trials present unique challenges and needs for medication standards.
- RxNorm's suitability varies depending on the specific requirements of the research design.
- Successful implementation requires tailored application and process strategies for different study types.
Conclusions:
- RxNorm can be a valuable standard for clinical research, but requires careful planning for implementation.
- Understanding the distinct needs of epidemiological versus intervention studies is crucial for effective RxNorm adoption.
- Sharing implementation experiences can guide future efforts in standardizing clinical drug data.
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