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The guessing game in clinical trial design—patient behavior

Thursday, January 15, 2015

We all know the commonly cited statistics about tri­als failing. But what is less talked about is the link between patients taking their medication and proof- of-efficacy.

According to the FDA, drugs fail for four reasons: efficacy, safety, chemistry/manufacturing/control and product labeling. The first two, efficacy and safety, are directly linked to medication adherence. What is worrisome is that they also account for 70% and 87% of drug failures in phases II and III, respectively.

The most accurate way to measure adherence currently is through bioassays. For example, in a six-month outpatient trial, participants typically have their blood tested slightly more than once a month. This means over the course of 180 days, we are captur­ing only about 10% of activity. The other 90% of the time, adherence is unknown in outpatient settings. Given the importance of adherence in ensuring a trial’s success, how much risk are we willing to toler­ate? While smarter monitoring of patient dosing is only suggested in FDA guidance, the full risk is with the sponsor.

Recent trials such as the failed VOICE trial (determining efficacy and effectiveness of PrEP for HIV prevention) have gone as far as in­terviewing many of the participants and asking them why they were not adherent. While pill counts and self-reports showed 90% adherence rates, blood levels showed less than 30% adherence.

Accurately measuring medica­tion adherence, engaging patients in understanding its importance and including adherence data in trial results have the potential to significantly improve our under­standing of drug efficacy and safety and lead to more successful trials.


Written by Guest Writer Adam Hanina. Hanina is CEO of AiCure, which uses artificial intelligence to confirm medication ingestion on mobile devices. Advanced facial recognition and motion-sensing technology accurately answers the question of whether or not participants are taking their medication. Hanina has acted as a subject-matter expert on medication adherence technologies for the NIH. He is a passionate advocate for the use of healthcare software as a means to better understand patient behavior, particularly in clinical trials. www.aicure.com

This article was reprinted from Volume 22, Issue 01, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns  focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.comSubscribe >>

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