Hopkins Laboratories, Inc. has developed a new diabetes drug called Sugardown.

Hopkins Laboratories, Inc. has developed a new diabetes drug called Sugardown. This drug is a first-in-class molecule and was submitted for an expedited review by the Food and Drug Administration. Trials demonstrated modest efficacy at lowering blood glucose.  Additionally, pre-clinical testing suggested a possible excess of kidney tumors in mice and rats.  

Good news!  FDA approves Sugardown but requires the company to begin phase IV post-marketing studies for effectiveness relative to existing diabetes drugs. This is unusual.  You are asked to take the lead in designing a study of its effectiveness. You work for Hopkins Laboratories, Inc. and your resources are virtually unlimited.

I want to see clear description of the hypothesis, study design, source of data, population, and description of exposure and outcomes assessment.  Any appropriate study design is acceptable.  I don’t need a statistical analysis plan, but I want you to comment on how you will overcome confounding by indication in this example.