Two Key Questions About Adherence/Compliance in 2020 PM360 Staff
This article was first published on PM360
July 14th, 2020
By PM360 Staff
PM360 asked experts who know how to improve medication adherence about the new challenges that COVID-19 will bring and what other barriers companies should pay particular attention to. More precisely, we asked them:
- How will the COVID-19 pandemic impact patient adherence? How can companies address short-term effects such as an inability to see their doctor, pick up prescriptions, or pay for medication? And what longer term impact on adherence and potential solutions to address it we will see even after more shelter-in-place orders are lifted?
- What barriers to adherence are not being addressed as much as they should? How can pharma better help patients to address these barriers? And what ways can pharma better work with patients to discover these unmet needs?
Intentional non-adherence, or those who wish to willfully delude sponsors, can be detrimental to a trial’s success, or lead to improper labeling once approved. Until recently however, the scope of its impact has largely been left unquantified. In partnership with the Tufts Center for the Study of Drug Development, AiCure published a study that leveraged an AI-powered virtual patient monitoring solution to understand intentional non-adherence across 23 clinical trials of psychiatric, neurological, and neuromuscular diseases. The results indicate that 4% of all confirmed doses were intentionally non-adherent, 48% of all study volunteers had at least one intentionally non-adherent dose, and 5% of study volunteers were intentionally non-adherent for more than one-third of all doses required.
Solutions that actively monitor a participant’s adherence behavior and treatment response can help weed out intentionally deceptive behavior and ensure sponsors are not reporting misleading data on the drug’s success. By analyzing behavioral patterns over time, the solution can predict which participants are at risk of not adhering to protocols, allowing sponsors to remove violators from the trial as necessary. These steps can enable a significant bump in drug efficacy and reduce the risk of real-world adverse events.