Authors: Collins MA, Schumacher A, Rujan T. 2016.
Introduction: Patient data collected during clinical trials represents a huge resource for translational research. Spanning the divide between highly regulated clinical trials and less regulated discovery research, this data ranges from data about the patient, such as medical history, demographics, and medications, to basic lab tests, biomarker assessments and sophisticated multiomics analyses (e.g. genomics, proteomics, metabolomics). This data can yield enormously valuable scientific insight.
In this paper we review the regulatory landscape and its impact on translational research, and define the key attributes of an "ideal" system to overcome the challenges of conducting translational research while respecting patient privacy.
Keywords: Data Security; Compliance; Translational Research; Precision Medicine; Patient Privacy; Protected Health Information.