SMART™ in Clinical Trials

Billions of dollars are spent each year on drug development, and the data generated in the clinical trials of those drugs is entirely dependent upon the trial participants taking the medication as prescribed. There is currently no way other than direct observation to ensure that trial participants are taking the trial medication as prescribed, and direct observation is prohibitive for many reasons.

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 drives an increase in enrollment by as much as 40%. This in turn brings increases the cost of clinical trials, and unnecessarily lengthens trial duration.

A 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-detectible. Phase II and Phase II clinical trials can then include adherence monitoring with the SMART system, producing reliable and definitive data which can help in analysis.

And because the SMART taggants are part of the approved drug, the approved drug will include the taggants when it is launched into the marketplace. Even if the pharmaceutical sponsor does not wish to pursue a label claim for breath-detectible monitoring for the drug, the inclusion of the taggants makes Phase IV post-marketing surveillance monitoring feasible.

Xhale's SMART system is the only existing technology which can definitively document patient adherence to a prescribed medication dosing regimen.