Background Clinical trials are widely considered
the gold standard in comparative effectiveness research (CER) but the high cost
and complexity of traditional trials and concerns about generalizability to
broad patient populations and general clinical practice limit their appeal.
Unsuccessful implementation of CER results limits the value of even the highest
quality trials. Planning for a trial comparing two standard strategies of
insulin administration for hospitalized patients led us to develop a new method
for a clinical trial designed to be embedded directly into the clinical care
setting thereby lowering the cost, increasing the pragmatic nature of the
overall trial, strengthening implementation, and creating an integrated
environment of research-based care
