Allan Wilson, MD, Ph.D.

Clinical trial costs are spiraling out of control. Recently completed studies have pegged the cost of bringing a new drug to market at from 500 to 800 million dollars. Data handling and pickup costs related to patient records account for a staggering 30 percent of drug development costs. Dig deeper into the issues Information Mediary has addressed in past reports and discover some further numbers on the cost of tracking non-compliance in clinical trials settings.

Consider the cost of recording dosing times, tempered with a good deal of uncertainty as to when medication was actually taken. Factor in the time spent deciphering often-incomplete patient diaries, which are sometimes filled out in the waiting room just prior to the follow-up visit. Now imagine paying someone $4.00 per page for the double data entry required to capture that information into an eCRF.

Are you in doubt as to when patients took their medication? Did they miss a dose? How does that affect your data? Is poor patient compliance adding noise to your study, making it more difficult to detect the signal (therapeutic effect)? In a clinical situation, how does poor compliance affect your ability to make a rational clinical decision about further therapy?

A manual query about the dosing regimen can cost $12 to $20 per page of information. How much does patient non-compliance cost you? The cost could be as high as $2000 to $10,000 per patient to record and handle data the reliability of which is suspect over the course of a study.

What if you had a way to identify non-compliant patients early in a study? They could be removed from the study, educated to increase their compliance, or their compliance data could be co-varied out in the statistical analyses of the data. This would result in considerable savings due to increased accuracy of data leading to more convincing study outcomes.

What if there was a better way? A way to get all your patient compliance information with direct data capture right at the source. A foolproof method of recording to the time each tablet or capsule was ejected from a blister package. That's Med-ic. That's ECM Electronic Compliance Monitoring - and it is commercially available in Q2 of 2003.

Med-ic ECM tags record when the patient removes a tablet or capsule from a blister package. Using the CertiScan RF Reader and CertiScan Software, a clinical trial administrator can retrieve and display at a glance calendars of patient compliance. This adds up to true cost savings through Compliance Data Capture (CDC) going directly to the source where it can be interpreted and acted on quickly and cost effectively.

Return to Non-Compliance.