Study Medication Compliance and Its Impact on Finding Treatment Efficacy

• Activity Number: 559
• Type: Topic Contributed
• Date/Time: Wednesday, August 3, 2011 : 2:00 PM to 3:50 PM
• Sponsor: Section on Government Statistics
• Author(s): Kousick Biswas*+
• Companies: VA Cooperative Studies Program
• Keywords: Clinical Trial ; Compliance ; Efficacy ; Experimental Treatment

Abstract

The efficacy of any experimental treatment depends on the treatment-compliance by the participants. The treatment-compliance in a clinical trial setting is measured using two most commonly used quantities - self reported use and pill count. Both of these measures are unreliable as these can be manipulated by the participants to report a higher compliance. In the experimental treatment research for substance abuse, a series of recently completed clinical trials ended being negative even though the experimental treatments were found to be beneficial in smaller pilot studies. In these studies compliance was measured using self report and pill counts and reported in the 85% - 95% range. In a recently completed negative study, an ad-hoc treatment-compliance analysis was undertaken using treatment concentration in the urine and a very little agreement was reported when compared with usual compliance measures. The negative findings in the efficacy outcomes may be attributed to a very low actual treatment-compliance. This finding calls for a serious discussion about a well known problem in clinical trials for experimental treatments for non-life threatening indications - measurement of tre