Clinical trials continue to face challenges in efficacious quality data for medication adherence due to heavy reliance on self-reporting by trial participants or use of adjunctive methods, such as video self-recording, to verify adherence to protocol treatment schedules. So much so, the Food and Drug Administration (FDA) sought to codify the necessity for using medication adherence strategies in final guidance issued in March, 2019. Despite this, and even with the acceleration of decentralized clinical trials since the COVID-19 pandemic, challenges remain due to the lack of adoption throughout the biotech ecosystem.

Application of medication adherence technology continues to prove fundamental for quality data reporting in clinical trials. Information Mediary Corp’s (IMC) eCAP smart pill bottle, Med-ic® smart dose blister packaging, and other hardware and software solutions continue to be instrumental in supporting groundbreaking drug trials; incorporation of Med-ic® in Abbvie’s Orilissa trials remains one of the most widely recognized examples for large scale medication adherence technology. Furthermore, companies, such as AARDEX Group, utilize IMC’s hardware to power data collection for medication adherence databases, e.g. the MEMS AS platform, for clinical trial sponsors, such as Merck, highlighting the vertical integration that medication adherence technology has with traditional clinical trial as well as decentralized clinical trial models.

A number of recently studies from psychiatry to cost reduction studies in usage of medication for chronic diseases, report incorporating of medication adherence technology in the study models. Reported data by the respective authors illustrates medication adherence being 85 to over 90%. For clinical trials that utilize medication adherence to accurately titrate dosing regimens, poor data quality can cause overdosing by as much as 50%. As a result, large patient populations outside of controlled conditions could be subject to more potent side effects, which would otherwise not be impactful at lower dosing concentrations. However, the push for positive outcomes quickly by trial stakeholders could be a cause for why technology measuring medication adherence is not widely adopted.

Although consensus remains mixed for medication adherence technology, the quality of the empirical data collected through smart packaging, such as IMC’s Med-ic® blister packaging, remains undisputed. As an innovative method toward quality control in clinical trials, this technology could be impactful toward prevention of resource wasting, such as over enrollment, a strategy often used for large participant cohorts, and streamlining database scrubbing to ensure completion of established endpoints. Additionally, the value proposition for this technology, although not necessarily seen in the immediate time frame, will yield significant cost savings as the traditional model of clinical trials shift to incorporate newer innovations and ideologies.