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Ethical Issues Are Important in “Standard-of-Care” Clinical Trials

01/10/2018

A Learning healthcare system (LHS) aligns science, informatics, incentives, and culture for continuous improvement and innovation, with a delivery process that is based on best practices while also capturing new knowledge. Integral to LHSs are clinical trials that compare interventions that are already commonly in use (as “accepted” or “standard-of-care”).

A Learning healthcare system (LHS) aligns science, informatics, incentives, and culture for continuous improvement and innovation, with a delivery process that is based on best practices while also capturing new knowledge. Integral to LHSs are clinical trials that compare interventions that are already commonly in use (as “accepted” or “standard-of-care”).

A new Learning Health Systems Research Report notes that close attention to ethical issues in specific standard-of-care randomized clinical trials is crucial if the LHS movement is to avoid ethical lapses that could be counterproductive to its long-term vision.

“There is a tendency to think that all 'standard-of-care' randomized clinical trials must be low or no risk to the participant,” said author Scott Y.H. Kim, of the National Institutes of Health. “I think this is an erroneous assumption that could lead to unfortunate consequences. Instead, each randomized clinical trial should be evaluated on its own merits, without relying on such a sweeping rule."

 

Additional Information

Link to Study: http://onlinelibrary.wiley.com/doi/10.1002/lrh2.10045/full

About Journal

Learning Health Systems (LHS) is an international, open access, peer-reviewed journal published in collaboration with the University of Michigan. LHS aims to advance the interdisciplinary area of learning health systems by promoting research, scholarship, and dialogue focused on theory, complex issues, conceptual syntheses, educational models, solution designs, and system evaluations designed to achieve continuous rapid improvement in health and healthcare and to transform organizational practice.

LHSresearch represents a new, trans-disciplinary science, and its contributors are researchers in fields such as behavioral, social, and organizational science; cognitive, information, and computer science; industrial and systems engineering, as well as other areas of expertise. Learning health systems research is focused across different levels of scale that include organizations, regional networks, and national and multi-national systems.

Penny Smith
+44 (0) 1243 770448
sciencenewsroom@wiley.com

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