Clinical Studies

Is compliance self-reporting undermining your research quality?

If your clinical trial participants are chosen from a vulnerable patient population, it’s likely they will have complex pharmacological needs that will have to be accommodated throughout the course of the trial. In addition, your research protocol will have to account for approximately a 30% attrition rate to adjust for non-compliance and abandonment. These two considerations alone can add hundreds of thousands of dollars to the total cost of your trial and can add many extra months to its length.

CuePath has developed a real-time medication compliance monitoring product. It is designed for clinical trials that dispense doses of tablets or capsules in blister packaging. Any time a dose is removed from the blister pack, it records the exact date/time. Missed or wrong doses are also logged. If reminders are needed, an electronic reminder device is supplied to the patient. Analysis is provided to the research team, to identify patients that are non-compliant, and spot patterns that may indicate diversion.

The resulting data generated from these actions will keep medication compliance in the high 90 percentile. Notifications may be provided, based on research protocol requirements. By monitoring medication compliance, the safety and efficacy of the medication is more accurately studied. By providing accurate visibility into patient compliance, CuePath improves research quality for clinical trials.

CuePath improves research quality by enabling researchers to:

• Enhance the accuracy and reliability of safety & efficacy analysis
• Reduce the risk of diversion for controlled narcotics
• Lower the overall study costs by reducing patient sample size