Journal
CLINICAL TRIALS
Volume 13, Issue 5, Pages 484-492Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1177/1740774516655097
Keywords
Learning health care system; adaptive trial; response-adaptive randomization; platform trial; multiple treatment domains; early stopping
Categories
Ask authors/readers for more resources
Background/aims A learning health care system ideally incorporates the ability to adapt to the pace of change, the incorporation of new clinical research paradigms, and leverages electronic health record systems and clinical decision support systems to narrow the divide between research and clinical practice. Methods An adaptive clinical trial can be embedded into the sites and practice of clinical care in a highly pragmatic way to simultaneously generate high-quality data on treatment efficacy and improve the care of patients. This approach can be expanded into a pragmatic platform trial, meaning a trial that is intended to evaluate multiple treatments for a disease or diseases, possibly in combination, and with the available treatments potentially changing over time. This strategy is illustrated using a trial currently being implemented in Europe and funded by the European Union, evaluating three different domains of treatments for patients with severe community-acquired pneumonia requiring intensive care. Results Simulation studies demonstrate that this approach has the potential to save lives while identifying the best treatment strategies for this critically ill population. Conclusion Patients are likely to benefit if we can merge clinical trials and decision support into a single continuous learning process.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available