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Article Title

Integration of Clinical Research Into Health Care Operations: A Comparison of Two Systems

Publication Date

8-15-2016

Keywords

clinical research, system model

Abstract

Background/Aims: Clinical research has become a common component of many health care systems, whether or not they embrace research on a strategic level. However, the nuances of clinical research differ from those of health care, opening the door for inefficiency, poor study outcomes and increased participant risk. We present here a comparative case study on two unaffiliated health care systems that successfully engage in clinical research via different models.

Methods: We examine the clinical research operations of two health care systems, Marshfield Clinic in Marshfield, WI, and Sentara Healthcare in Norfolk, VA. Each system brings unique attributes to the administration of clinical research, including patient population, support infrastructure, physician engagement, regulatory compliance, financial performance, and overall study selection and conduct. Each of these factors are assessed and presented in a comparison of the models each health care system utilizes.

Results: The clinical research operations of the two health care systems described present successful models for the integration of research into health care. Similarities exist, but an analysis of their different approaches will provide valuable information to other sites faced with comparable challenges.

Conclusion: Clinical research is engaged in an environment of contrasts. It shares some common elements such as regulatory requirements and compliance. Drastic differences also can exist between organizations, such as the types of patients served and the engagement of physicians and organization leadership. Understanding how to identify and address these differences can facilitate more successful research overall, providing benefit to all health care systems.

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