• Monitor compliance with Control containers which record dosing events without reminder lights.

• Add reminder lights on the Study container.  "Dose now" flashes at subject’s dose time to help subjects:

a.    Remember dosing instructions.

b.    Avoid double-dosing because of memory lapse.

c.    Reinforce medication compliance.

d.    Monitor compliance.

• Add legs to a trial to demonstrate value of improving compliance for efficacy and sales.

a.    Control containers (without reminder lights) which record dosing events.

b.    Study containers (adding reminder lights) which record dosing events.

Advantages of using DoseCue compliance monitoring only:

• Provides detailed data on compliance for each subject eliminating the mystery of compliance as a cause of efficacy variability.

• Compliance may be used as covariates for efficacy (i.e., efficacy dependency on compliance) or panel may be stratified afterward by compliance criteria.

• Compliance variable may be used in a variety of ways to improve treatment-effect statistical validity (e.g., am/pm dosing, before/after meals).

• In place of conducting dose-ranging studies, investigators instead may cite efficacy and adverse-event dependencies on compliance, i.e., lower compliance as a proxy for lower-dose range.

Advantages of using DoseCue monitoring and reminder lights:

• Enhances compliance so a drug has it best chance of demonstrating expected efficacy.
   
• Demonstrates impact of enhancing compliance on outcomes and product usage.