Phase II & III
In Phase II and III clinical trials, Xhale's breath-based SMART system for documentation of medication adherence offers unprecedented capabilities and advantages as a tool for drug development. Poor compliance with dosing regimens can negatively affect key efficacy measures in Phase II and III, where an estimated 15%-50% of enrolled participants do not take the study drug as prescribed.
Other than SMART technology, there is no accurate means to know which patients adhere to the dosing in the clinical protocol, or to precisely define the relationship between the development of adverse events and the timing of dosing. For drugs that are difficult to administer, or need to be taken precisely on schedule (before meals, before bedtime, 12 hours apart, etc.), the only way to understand the pharmacokinetics is to accurately know dose ingestion timing. In these and many other situations, the capabilities of SMART will be a useful tool for discriminating between those subjects not taking the medication and those who are adherent, but not benefiting from the study drug.
The aggregate cost of clinical trials is driven by the high failure rate of drugs in development - just one in five drugs that begin human trials is eventually approved for marketing. Errant trial data caused by the failure of participants to adhere to the testing regimen could result in a valuable drug failing to reach the market. With the cost of bringing a new drug to market at more than $800 million, minimizing the incidence of false positives and negatives in the trial data is an important issue.
Other significant cost drivers for clinical trials include both the number of patients who must be recruited and the length of time recruitment takes. Due to the possibility of errant trial results caused by a failure to document patient adherence, statistical methods used in analyzing trial data requires significantly higher patient enrollment. Trial participants not taking the study drug as prescribed confound results, cause as much as 40% additional enrollment requirements plus corresponding costs, and unnecessarily lengthen trial duration. In order for the results to be acceptable to the FDA, the number of patients needed to complete a drug trial has almost doubled in the past 10 years. By providing a superior data set for optimal decision-making, SMART technology may enable a safe reduction in the number of trial participants, reducing overall trial cost and decreasing the trial duration.