Members of the NIH Pragmatic Trials Collaboratory Ethics and Regulatory Core published a new article in Contemporary Clinical Trials exploring the ethical and epistemic advantages and challenges specific to pragmatic stepped-wedge cluster randomized trial designs.

The article titled “Ethical and Epistemic Issues in the Design and Conduct of Pragmatic Stepped-wedge Cluster Randomized Clinical Trials” was published online ahead of print in a special issue on pragmatic and virtual trials.

The authors draw on real-world examples from 5 NIH Collaboratory Trials: ACP PEACE, LIRE, NOHARM, PRIM-ER, and TSOS. The article examines practical, ethical, and epistemic issues faced by these NIH Collaboratory Trials.

In a traditional parallel cluster randomized trial, some clusters receive the intervention while other clusters do not, potentially depriving this control group of a beneficial intervention.  The stepped-wedge cluster randomized trial (SW-CRT) design takes steps toward minimizing this ethical dilemma by rolling out the intervention to all clusters over a predetermined time schedule.  This type of trial may have logistical and statistical advantages for researchers while allowing all study groups the opportunity to benefit from the intervention.

The unique design of SW-CRTs may also lead to regulatory challenges involving informed consent, bias due to contamination of the control clusters, or changing study conditions due to the extended length of time over which an intervention is rolled out.  The decision to conduct a pragmatic SW-CRT requires careful consideration of these challenges weighed against the possible advantages.

The NIH Pragmatic Trials Collaboratory is supported by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director, and through the NIH HEAL Initiative.