Point-of-Care Clinical Trials

Widespread implementation of the electronic health record and the resultant availability of digitized patient data provide an opportunity to transform the conduct of clinical research. This chapter will discuss point of care (POC) clinical trial design, a methodology that uses electronic health record systems to embed randomized comparative effectiveness research in clinical care. Trial design characteristics, electronic health record requirements, informatics and statistical considerations to conduct this type of research will be presented as will be implementation of study results into the clinical care ecosystem. A point of care clinical trial of an interventional procedure is presented to demonstrate advantages and limitations of this methodology. This chapter highlights how integration of clinical trials with clinical care serves as a scalable model for healthcare system learning.

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