A pharmaceutical company wishes to develop and market a new medication to control blood sugar in diabetic patients. Suggest a clinical trial for evaluating the efficacy of this new medication.

a. Describe the criteria you would use to select cases or patients.

b. Is there a treatment to compare with a competing treatment or against a placebo?

c. How do you measure effectiveness?

d. Do you need to address the safety aspects of the treatment?

e. Have you planned an early stopping rule for the trial if the treatment appears to be unsafe?

f. Are you using blinding in the trial? If so, how are you implementing it?

What problems does blinding help you avoid?