XHALE SMART® | An Xhale, Inc. Company
Smart® 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.
Before a drug candidate can receive marketing approval, the drug candidate must undergo extensive clinical trial testing in order to establish safety and effectiveness.
A concern of pharmaceutical companies who sponsor and fund these clinical trials is the lack of patient adherence to the specified drug regimen of the trial’s protocol. Adherence can vary from trial to trial. According to an article published in The New England Journal of Medicine in 2005 (Lars Osterberg, M.D. and Terrence Blaschke, M.D., “Drug Therapy: Adherence to Medication”), reported average adherence rates among patients in clinical trials receiving treatment for chronic conditions are 43% to 78%.
If participants do not take the drug candidate according to the specified regimen in the applicable trial protocol, effectiveness of the drug candidate may not be established in the clinical trial and the drug candidate may not be approved.
Non-adherence can be an important source of variability in participant drug candidate responses in clinical trials, and high rates of non-adherence can result in a clinical trial which fails to prove the subject drug candidate’s effectiveness.
In response to the lack of participant adherence to drug regimens in clinical trials, the sponsors of such trials may be required to increase the number of participants in the clinical trial to attempt to produce a higher likelihood of success of the clinical trial. An increase in the number of participants increases the overall cost of the clinical trial.
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® marker, 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.
Unlike other existing approaches, the SMART® system is designed to definitively verify that the right person took the right dose of the right medication at the right time.
The SMART® Adherence System, is now available for research use in the collection and reporting of definitive treatment adherence data in clinical studies.