Maximizing Opportunities in Genomic Research
Clinical genomics is believed to have high potential for improving precision, effectiveness and outcomes in health care—part of a movement toward more individualized health care. The role of data exchange is especially significant for clinical genomics, both as an important element of research and ultimately in bringing together genomic knowledge and individual clinical information for improved treatment.
On October 15, 2009, the Department of Health and Human Services sponsored a stakeholders workshop—Identifying Opportunities to Maximize the Utility of Genomics Research Data through Electronic Health Information Exchange—in Washington. The goal was to recognize and consolidate early efforts, work together toward harmonization of data recording and exchange in the clinical research setting, and build toward the longer-term goals of improved patient care through use of genomic information.
Participants represented the spectrum of stakeholders: academic and medical centers, government research and public health agencies, standards-making organizations, health information technology and informatics specialists, consumer advocates, pharmaceutical companies, and other business and investment interests. Among those presenting in the day's interactive approach were:
- Jesse Goodman, Chief Scientist at FDA
- John Halamka, chair of the U.S. Healthcare Information Technology Standards Panel
- Daniel R. Masys, chair of the Department of Biomedical Informatics at the Vanderbilt University School of Medicine
These leaders looked at near-term opportunities to strengthen the foundation for clinical genomics by identifying candidates for standards harmonization, and more specifically, they:
- Reviewed current processes of genomics research and standards already in use
- Assessed the readiness and completeness of existing standards
- Identified gaps and barriers
- Worked toward a consensus pathway leading to harmonization of existing standards as well as coherent development of future standards
In particular, the workshop looked at activities and needs in the clinical research area, especially the need for data standards adequate to capture all important elements in the workflow of genomic research.
The aim of the workshop and follow-up harmonization efforts will not be uniformity in research approaches or analytical methods, but rather the ability to adequately capture and transmit information about all processes in a standardized manner.
The workshop achieved consensus regarding a pathway for harmonization efforts that can be undertaken within approximately a three-year time frame.