SMART™ in Clinical Trials
Xhale's SMART system provides the first method of proving that participants in pharmaceutical trials are taking the right medication in the right dose at the right time during the trial.
Estimates of the number of patients enrolled in clinical trials who do not take the study drug as prescribed range from 15% to 50%. Trial participants not taking the study drug as prescribed confounds results, which can drive an increase in enrollment by as much as 40%. This in turn increases the cost of clinical trials, and unnecessarily lengthens trial duration. Xhale's SMART system can definitively track and record each trial participant's actual medication ingestion and correlate it to significant study events, providing a superior dataset with improved interpretation of safety and efficacy data.
The SMART system is elegant: Any drug at any stage of development can easily be converted into a SMART version by incorporation of a capsule or coating with the SMART taggants, making it breath-detectable. Upon enrollment, trial participants are issued a SMART monitor, and the SMART version of the trial medication. The monitor serves the patient as an electronic medication reminder as well as prompting them to blow into the device after each dose. The monitor detects the taggants in the breath, providing definitive proof that the medication was taken. An electronic record of the date and time of the dose is then stored or transmitted for inclusion in the trial dataset.
Because the SMART taggants are an ingredient in the SMART capsules which are used in clinical trials, and those capsule ingredients are typically incorporated into the DMF on file with FDA, the final approved drug will usually be manufactured with the SMART taggants when it is launched into the marketplace. Even if a pharmaceutical sponsor does not wish to pursue a label claim for the breath-detectable SMART version of the drug, the inclusion of the taggants enables effective and efficient Phase IV post-marketing surveillance monitoring.
Xhale's SMART system is the only existing technology which can definitively document patient adherence to a prescribed medication dosing regimen, recording the exact time and date each dose was actually taken.