Clinical Trials Monitoring

Benefits in Clinical Trials

Billions of dollars are spent each year on drugs in clinical trials, and the data generated in those trials is entirely dependent upon the trial participants taking the medication as prescribed. Participants not taking the trial medication as prescribed can result in new and helpful drugs never reaching the market because of erroneous human trial data from noncompliance. By using SMART technology with the trial drug, making it breath-detectible, trial participant adherence can be tracked and recorded with definitive accuracy.

Xhale's SMART system allows definitive monitoring of patient adherence to dosing/timing protocol in clinical trials. The system is an operational surrogate for direct-observation of the trial participant taking the medication, definitively tracking and recording each trial participant's actual medication ingestion and correlating it to significant study events. The system results in a superior dataset with improved capacity for interpretation of safety and efficacy data.

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, enabling cost-effective and robust Phase IV post-marketing surveillance.

With the SMART taggants as part of the approved drug, a pharmaceutical sponsor has the option to pursue label claims for the breath-detectible SMART version of the drug, and the SMART drug version will enjoy additional market exclusivity as a result of the underlying Xhale patents.