Merck & Co. is investing in innovative approaches to strive to enrich clinical trial data and augment decision making by utilizing digital health technologies and rea-time data access. To take strategical strides, a Phase 1 study was conducted to explore some technologies of interest, such as CMT’s CleverCap. Merck has launched the “Smart Trials”, a cross-functional multi-year initiative aimed at leveraging digital health to make clinical trials patient-centric instead of site-centric.

The criteria for selecting a smart dosing device included the study drug formulation, the type of technology (i.e. packaging devices versus ingestion tracking), device capabilities, data capture, and vendor maturity. The study is a fixed-sequence two-period trial that included 16 subjects who were administered daily with the study medication packaged in a CleverCap that electronically captured the date and time it was dispensed. CleverCap PRO, a smart device of CMT, allowed the study drug to be dispensed by the pharmacy in its commercial formulation, provided subject dosing reminders, and also enabled real-time monitoring of subject adherence via a web-based portal. With the results of this study, it exhibits the feasibility and subject acceptance of collecting digital adherence data in clinical trials.

Study Results

“At the end of Period 1, 222 of 224 expected doses (99%) were recorded as dispensed by the CleverCap PRO®. All but one of the 222 recorded dispensing events were in accordance with the protocol-specified dosing instructions of one dose per day between 6:00 and 10:00 AM, and the other fell just outside the protocol-specified range (10:09 AM).”

Subject Questionairre

“Subject feedback on CleverCap PRO® was generally very positive. The average (standard deviation) Net Promoter Score for CleverCap PRO® was a 9 (1.41) out of 10, which indicates the subjects were strong supporters of this technology.”


“Electronic adherence solutions such as CleverCap PRO® represent an opportunity to improve the reliability of dosing data from clinical trials, and the results from this study demonstrate the feasibility of utilizing smart packaging in clinical trials. While medication dispensing time from a smart package is not an ideal surrogate for time of medication ingestion, it is significantly more accurate than the currently accepted standard of paper diary and provides a passive means of data collection that reduces the burden of self-reporting dosing times by the subject.”


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