Medication Adherence Data Used Proactively in Clinical Trials
From clinical trial enrollment through completion, understanding medication adherence is critical to data integrity and AiCure offers a competitive edge where traditional methods fall short.
To ensure trial participants are complying with dosing regimens, sites often rely on traditional patient reported outcome systems with participant diaries, which can be unreliable. Also in common use are dated technologies such as electronic pill caps and reliable, but often delayed, pharmacokinetic (PK) data. These approaches don’t allow for timely or targeted intervention by site staff.
Using AiCure technology, adherence can be considered proactively, allowing sponsors to assess a participant’s potential to comply with the protocol before a trial even begins. During a two-week run-in period, participants who show they can be highly compliant to the protocol can be identified, as well as those who have difficulty participating in the trial regimen as designed.
“[Sites] are taking a lot of things that have been done historically in trial design, and enhancing the level of confidence and quality using technology,” said Amanda Paley, VP Commercial Development & Strategic Solutions at AiCure, in a webinar about real-time dosing. Learn more by watching “Real Talk, Fresh Takes: How Sage Therapeutics is Unleashing the Operational Value of Real-Time Dosing Data.”
A participant’s day-to-day routine and current mental health condition are key predictors of adherence. For example, mental illness can hinder participant judgment, affecting their ability to take a medication. Alternatively, some participants unintentionally skip the medication or intentionally ignore instructions. In either case, sites do not learn about this non-adherence until later in the trial. This results in the loss of critical information about a patient’s well-being and how a medication is performing.
If sites solely rely on self-reported diaries and electronic pill bottles, adherence levels are difficult to assess, which is why AiCure leverages computer-vision via smartphone to visually confirm dosing during trials (including attempts to feign compliance such as concealing a pill under the tongue).
Using AiCure Technology to “Drive Action”
Sarah Titus, MPH, Director of Clinical Operations & Development at Sage Therapeutics, discussed her organization’s experience with AiCure during the webinar.
“The thing I’ve been focusing on is really using AiCure for, rather than a passive data collection tool, is to drive action,” said Titus.
Sites are provided with actionable data via AiCure’s platform, providing them with additional visibility between study visits which enables them to more proactively manage their patients based on patterns of adherence behavior flagged by AiCure.
Targeting non-adherence has become more urgent in recent years. A 2021 systematic review and meta-analysis of medication non-adherence in BMJ Open among people living with multimorbidity found a 42.6% prevalence of non-adherence with unintentional missed doses more common than intentional non-adherence.
“The [site] interaction might not be the same between a typical person who is forgetful or who is struggling to adhere to something new in their lives versus someone who may be willfully not compliant with a protocol,” Titus added.
Understanding this dichotomy is critical to enriching the relationship between sites and participants, and helps sites determine appropriate follow-up strategies.
On the Sponsor side, AiCure data helps build more proactive site selection criteria. By partnering with sites that deliver higher quality medication adherence these sponsors have improved clinical trial operating performance.