Qual-IT - January 2006 | Archived

At the federal level, the National Institutes of Health (NIH) has developed a strategic roadmap for transforming research methods by emphasizing “translational” science—research geared to facilitating communication, and accelerating the application of findings, between researchers and practitioners. Electronic health information systems will play a pivotal role in such efforts, greatly enhancing, for example, the large-scale collection of data needed for sophisticated analyses of genetic information, and for the development of personalized treatment regimens tailored to individual genetic profiles.

In 2005, NIH announced a critical new element of this effort, the Institutional Clinical and Translational Science Awards (CTSAs). These will provide grants for training and research to advance this new transformative research vision. Pursuing these grants will require research institutions to collaborate on their clinical research information systems.

Several core elements of the national health information technology agenda are, in turn, similarly relevant and essential to achieving the broad goals of clinical research. The 2004 Department of Health and Human Services strategic plan for HIT identified four broad objectives integral to improving health care: informing clinicians, connecting clinicians, personalizing health care, and improving population health. Regarding this last objective, the plan recognizes that HIT can help advance bench-to-bedside research and more rapidly disseminate its findings to clinicians at the point of care.

Specific elements of the strategy include widespread adoption of HIT tools, interoperability of health information systems, development of data collection standards, and adoption of access policies and procedures that adequately maintain privacy and security at all levels of the system. Likewise, the data necessary for clinical practice improvements constitute the same building blocks vital for clinical research—i.e., information from physicians' offices, hospitals, laboratories, and pharmacies, as well as from patients themselves. Building these requirements around a common infrastructure and set of standards will enhance the efficiency and effectiveness of the health care system's investment in HIT.

Major collaborative initiatives such as the Human Genome Project have already yielded important insights on the relationship between genetics and disease, but much additional work is needed to further decipher and refine these relationships, work in which HIT plays a crucial role. Specific areas of focus include analyzing genetic information derived from biological samples against a backdrop of rich phenotypic data—i.e., observations on the physical manifestations of the individual's genetic “coding”—as well as demographic and family health information, in order to identify genetic patterns of disease origin and development. Investigating or identifying such genetic markers requires repositories of genetic material and accompanying data large enough to afford sufficient baseline information about a specific genetic pattern or disease—necessitating, in turn, cross-institutional collaborations to collect and pool these diverse genotypic and phenotypic resources. The spread of electronic health information systems will further enhance this collaborative data collection and sharing throughout the research-to-practice continuum.

In New York, many academic health centers are engaged in pioneering clinical research in which HIT figures prominently. Promoting collaboration among institutions is a priority of the AMDeC Foundation, a consortium of 35 medical schools, academic health centers, and research organizations working to advance biomedical research and technology in the state. Indeed, building a comprehensive, rich clinical database is itself a component of AMDeC's Integrated Translational Genomics Program, or InTraGen.

InTraGen seeks to provide New York biomedical researchers with a state-of-the-art infrastructure for genomics and translational research. It consists of the Bioinformatics Core Facility (housed at Columbia University), the Microarray Resource Center (coordinated from the University of Rochester), and the roboticized biorepository (situated at North Shore-Long Island Jewish Health System) and informatics center (based at Columbia University), which store, respectively, blood samples from and accompanying personal/medical information on nearly 20,000 enrollees in the AMDeC-sponsored New York Cancer Project. A Proteomics Resource Center and Stem Cell Analysis Repository may become future components of this work.

These research-focused initiatives have produced significant benefits in terms of both clinical advances and the ability of New York institutions to compete effectively for additional federal and state funds. But creating these data and DNA repositories is also very resource-intensive, because current health information systems are neither standardized nor interoperable, and may not be capturing the types of information required for research. Thus, broader adoption of HIT holds great potential to make data collection more robust and efficient.

Even more important, electronic health information systems can play a vital role in translating and disseminating clinically relevant research findings to the point of care, for direct impact on clinician practices and patients alike. It is already widely understood that HIT can, for example, rapidly and reliably identify individual patients who are taking certain drugs for which additional contraindications may be discovered, or that may be subject to recall. Far broader impact could accrue, however, from the compilation of population-based data, not only to determine the comparative effectiveness or cost of specific treatment regimens but also to tailor them more precisely based on demographic and genetic information.

Buffalo's Roswell Park Cancer Institute (RPCI), for example, is focusing on the benefits of HIT in the context of a comprehensive process improvement strategy called the Sunrise Project, which encompasses research and clinical practice. The project seeks to improve the quality, safety, and efficiency of care, while also improving access to and use of data for research and consumer information. Those goals require interoperability of an institution's major HIT resources—the electronic medical record (EMR), laboratories, and biospecimen tracking systems, for example—to ensure that information readily and reliably flows across HIT and clinical boundaries. RPCI will thus leverage its EMR system to improve administrative and clinical processes and better manage and track clinical trials and other research efforts. The Institute is also participating in the National Cancer Institute's national bioinformatics initiative (caBIG), which will link leading cancer institutions, researchers, and data resources.

Physician and patient education and outreach can also be enhanced through the use of HIT. Lack of information about clinical trials is a fundamental barrier to enrolling subjects in those trials, and thus impedes both research and the ability to meet individual patients' needs. Responding to this widespread problem, the Parkinson's Disease Foundation, in collaboration with several other organizations, has developed a website—www.PDtrials.org—that  provides a variety of tools and resources for clinicians and patients. For many conditions—Parkinson's, cancer, and Alzheimers, to name a few—there are more, and more effective, treatment options available when the condition is detected early and when there are sufficient demographic and genetic data to allow a personalized regimen. By using a web-based tool as an entry point for clinical trials that involve a wide spectrum of symptoms and disease profiles, patients can educate themselves about and pursue the most optimal treatments.

The clinical research community has very specialized HIT needs, but it is clear that such needs are closely aligned with the interests of practitioners in terms of broad adoption of HIT. Standardization of data and HIT interoperability are major concerns in both clinical practice and underlying research. Policy and operational concerns regarding access, privacy, and security also cross clinical and research boundaries. And both clinical practice and research must incorporate outreach and education to inform patients about the need for their active participation, including using HIT tools for clinical trial enrollment, to both upgrade clinical care and drive the research enterprise.

AMDeC Foundation, Inc. (AMDeC). www.amdec.org

Cancer Genome Atlas pilot project, a collaboration of the National Cancer Institute and National Human Genome Research Institute. http://cancergenome.nih.gov/index.asp

National Cancer Institute (NCI) Biomedical Informatics Grid. https://cabig.nci.nih.gov/

National Institutes of Health Roadmap for Medical Research. http://nihroadmap.nih.gov/index.asp