Introduction.- Section I: Contexts of Clinical Research Informatics.- From Notations to Data: The Digital Transformation of Clinical Research.- The Clinical Research Environment.- Methodological Foundations of Clinical Research.- Informatics Approaches to Participant Recruitment.- The Evolving Role of Consumers.- Clinical Research in the Post-genomic Era.- Section II: Data Management and Systems in Clinical Research.- Clinical Research Information Systems.- Study Protocol Representation.- Data Quality in Clinical Research.- Patient-Reported Outcome Data.- Biobanking Challenges and Informatics Opportunities.- Laboratory Data.- Patient Registries.- Knowledge Representation and Discovery.- Section III: Knowledge Representation and Ontologies.- Non hypothesis-driven Research: Data Mining and Knowledge Discovery.- Natural Language Processing, Electronic Health Records, and Clinical Research.- The Future of Clinical Research, Health, and Clinical Research Informatics.- Data Governance.- Data Sharing: Electronic Health Records and Research Interoperability.- Standards Development and the Future of Research Data Sources, Interoperability, and Exchange.- Pharmacovigilance.- Clinical Trials Registries and Results Databases.- Future Directions in Clinical Research Informatics.
This extensively revised new edition comprehensively reviews the rise of clinical research informatics (CRI). It enables the reader to develop a thorough understanding of how CRI has developed and the evolving challenges facing the biomedical informatician in the modern clinical research environment. Emphasis is placed on the changing role of the consumer, and the need to merge clinical care delivery and research as part of a changing paradigm in global healthcare delivery.
Clinical Research Informatics presents a detailed review of using informatics in the continually evolving clinical research environment. It represents a valuable textbook reference for all students and practising healthcare informaticians looking to learn and expand their understanding of this fast-moving and increasingly important discipline.
Dr. Richesson is an Associate Professor of Informatics at the Duke University School of Nursing and Associate Director for Research at the Duke Center for Health Informatics. She works with a number of different clinical research networks and pragmatic clinical trials, and supports the development and use of data standards.
Dr. Andrews is an Associate Professor of Informatics and Director of the School of Information at the University of South Florida. His scholarship focuses on a issues related to health information behaviors, particularly in the context of genetics, and terminologies in healthcare and research.