Electronic Monitoring System to Assess Patient Adherence in Pediatric Drug Studies

Abstract

Abstract: : Purpose: The purpose of this study is to assess the feasibility of using the MEMS® SmartCap® electronic monitoring system to measure patient adherence to a drug-dosing regimen in a pediatric clinical trial of an investigational topical ophthalmic medication. The SmartCap is an electronic cap to a medication bottle that houses dispensed medications. It is designed for use with oral multi-use pharmacy bottles, but was adapted for topical ophthalmic medications by placing the gel tube inside the pharmacy bottle. Methods: Pirenzepine is a relatively selective M₁-muscarinic antagonist. Formulated as a preserved gel and dispensed in an ophthalmic tube, it is under investigation for topical ocular use to retard the progression of pediatric myopia. We conducted a double-masked, placebo-controlled study in children ages 9-12 years with myopia. As part of, but incidental to, the clinical study, subjects were given a MEMS SmartCap with their study medication. Its purpose was explained and its use demonstrated. At scheduled visits, data from the electronic monitors were collected and analyzed. Results: MEMS monitors were used by 19 subjects starting at the 11^th to 15^th month in the study (range: day 276 to 447) and continuing for an average of approximately 100 days. The average overall compliance (total number of doses taken divided by total number of doses prescribed) was 64% (range: 10% - 97%). The mean proportion of doses taken in the morning was 45.2 ± 8.5% (range: 29-58%), suggesting no predominate morning or evening compliance. The proportion of doses taken on any day of the week was approximately 14%, suggesting no large difference in weekday versus weekend compliance. Conclusions: Overall compliance was approximately 60% for ophthalmic medication dosing. Use of the MEMS SmartCap appears to be a feasible approach to assessing patient adherence in pediatric investigational drug studies.

Keywords: pharmacology • clinical (human) or epidemiologic studies: sys • clinical research methodology