Robust clinical trials in diabetes; from design to publication
Randomized clinical trials are critical for diabetes-lowering medications, as confounding by indication, prescriber, clinical situation, and co-morbidities are severe in observational studies. Standards for clinical trials are well described elsewhere, but trials of glucose lowering medications give special problems over population selection, choice of endpoints, duration and exposure, and aspects of safety and tolerability monitoring. Lessons from clinical trials conducted from 1980 to the present will be discussed.