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The overall goal of the NIH HCS Research Collaboratory program is to strengthen the national capacity to implement cost-effective large-scale research studies that engage health care delivery organizations as research partners. The aim of the program is to provide a framework of implementation methods and best practices that will enable the participation of many health care systems in clinical research, not to support a defined health care research network. Research conducted in partnership with health care systems is essential to strengthen the relevance of research results to health practice.

Under the aegis of the NIH HCS Research Collaboratory Program, the NIH expects to:

  1. establish a Coordinating Center that will provide national leadership and technical expertise in all aspects of research with HCS
  2. support the design and rapid execution of a set of high impact Demonstration Projects that will conduct research studies in partnership with health care delivery systems
  3. make available data, tools and resources from these and other projects to facilitate a broadened base of research partnerships with HCS.

The increased adoption of health information technology tools is not only changing how care is delivered but also providing opportunities for expanded participation of health care delivery organizations in research. Equally, the potential to conduct research studies in real world settings on large numbers of participants allows questions to be addressed that researchers could not feasibly address with paper records. In the last two decades health care delivery organizations have played valuable roles in a number of research projects and health surveillance activities funded by NIH institutes and centers and by other U.S. agencies. However, most studies have utilized health care data but have not conducted studies that require active engagement of patients or their practitioners as research participants or researchers. Moreover, these efforts have generally focused on the needs of specific studies and not on the overall process for engaging health care systems as partners.

Although the importance for biomedical research of strengthened partnerships with organizations that deliver health care is clear, many challenges exist, both cultural and practical. Many ethical and regulatory issues must be addressed to perform research in the health care delivery setting. Technical challenges to accessing and aggregating data from health care systems in understandable ways are not trivial. Health care providers’ focus is on providing the best treatment based on current knowledge whereas research studies have typically focused on studying which treatments work best in a precisely defined population. Research studies have frequently used endpoints that are not part of the normal evaluation of patients during a routine visit and interventions that are impractical in most care delivery settings. Policy issues can arise due to conflicts between the mission of delivering health care and that of generating new knowledge. The NIH HCS Research Collaboratory program will create a broad framework to tackle some of these major challenges.


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