title: The pragmatic clinical trial in a learning health care system.
abstract: 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.
  
  
  
  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.
  
  
  
  Simulation studies demonstrate that this approach has the potential to save lives while identifying the best treatment strategies for this critically ill population.
  
  
  
  Patients are likely to benefit if we can merge clinical trials and decision support into a single continuous learning process.
authors.affiliation: Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, CA, USA David Geffen School of Medicine at UCLA, Los Angeles, CA, USA Los Angeles Biomedical Research Institute, Torrance, CA, USA Berry Consultants, LLC, Austin, TX, USA roger@emedharbor.edu.
authors.forename: Roger J
authors.initials: RJ
authors.lastname: Lewis
mesh_terms: D000046:Academic Medical Centers / Q000458:organization & administration*; D035843:Biomedical Research / Q000379:methods*; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D012107:Research Design; D014481:United States
keywords: Learning health care system; adaptive trial; early stopping; multiple treatment domains; platform trial; response-adaptive randomization