Ethical issues are important in ‘standard-of-care’ clinical trials

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.”