How to Improve Medication Adherence in Clinical Trials

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We met the contributors for today’s guest post through their promotion at the DIA 2015 conference and they kindly agreed to provide an article on Medication Adherence. in clinical trials today, a specialized dispensation device called CleverCap has helped some sponsors achieve better medication adherence and compliance mesasurement.The CleverCap helps patients take the right dose, at the right time, combined with alerts, tracking, third-party notifications and a centralized data portal for information management.

We asked our guests for a few examples of how a system like CleverCap could better control for high quality clinical data. Their perspective below, what would you add? Thanks! -Nadia


Medication Adherence

Every dose, taken regularly at the right time

In clinical trials, new drug compounds can fail to demonstrate therapeutic efficacy due to poor medication adherence. In Phase I trials, doses are given in a controlled facility with witnessed mouth-checks. We know the patient took the medication properly because the dosing is observed. However, in Phase II trials and beyond, patients will carry their medications away from the clinic for at-home dosing, typically in blister packs or bottles.

No witness may mean no confirmation of medication adherence. Will they forget? Will they take too little? Too much? Will they take the medication exactly as instructed?

Achieve higher quality clinical outcomes

Clinical trial managers, investigators, researchers and pharmaceutical sponsors can have better insight into medication adherence. If you take control of compliance,  you can improve data analysis and reporting and achieve higher quality clinical outcomes.

Use the Right Tools to Monitor Analyze and Improve Data

Stat Graphic 1Research shows that medication adherence in clinical trials is both poor and highly variable among groups and individual patients.

Only 34 percent of patients take their medications as prescribed. Adherence tools and more robust compliance data collection are areas where we can improve (not just with paper or electronic diaries).

Real-time access to data that confirms whether participants are taking the correct dose, on schedule, helps researchers work with participants to stay on track – or remove them from a study.

The ability to document behaviors, timelines and other data adds credibility to these decisions.  More robust medication adherence can be achieved with digital adherence tools versus insufficient self-reporting or simple pill counts.

Manage Dosing for Best Results

Well-designed clinical trials will limit the flexibility around dosing intervals. If trial participants don’t adhere to trial requirements, skip dosages or take medications off schedule, the efficacy data may be compromised.

slider3_leftMedication adherence is critical to support recommendations around accurate dosing. Systems like the CleverCap adherence platform can accurately record the multiple data points required to identify strong or poor adherence.

Data-Driven Efficacy

The ability to monitor medication adherence provides more confidence in efficacy results.

To learn more about this topic and the CleverCap medication adherence platform, check out the medication adherence resource library on and How poor medication adherence is damaging your clinical trial data and how to fix it, fast.Cover ebook large

About The Author


Nadia Bracken, lead contributor to the Lead CRA blog and the ClinOps Toolkit blog, is a Clinical Program Manager in the San Francisco Bay Area.

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