Imagine spending years developing a promising new treatment, only to have its potential clouded by something as simple (and as overlooked) as whether or not people actually took their pills. This isn’t just a small glitch in the process. In clinical trials, medication adherence can make or break your results. Yet, it’s often treated as an afterthought.
What is medication adherence?
Medication adherence refers to whether patients follow their prescribed treatment regimen. This includes:
- When they start taking the medication
- How often they take it (e.g., once a day, twice a day)
- How accurately they follow the instructions
- If and when they stop taking it altogether
This process is often broken down into three stages, known as the ABC taxonomy (Bernard Vrijens et al, 2012):
- Initiation – when the patient takes the first dose
- Implementation – how closely they follow the dosing schedule
- Discontinuation – when the patient stops the treatment
Each of these steps matters. If a patient delay starting treatment, skips doses, or stops early, the drug’s effect may not be properly measured.
Why is adherence so important in clinical trials?
In clinical trials, we want to know whether a new drug works. But if patients don’t take the medication correctly, the data becomes unreliable. Imagine testing a new treatment, only to find that half the participants missed doses or stopped early. The results would be all over the place, making it hard to tell if the drug is effective or not.
Poor adherence can:
- Hide true effectiveness – the drug might work, but not enough patients took it correctly.
- Distort safety signals – side effects might appear more or less frequently than they should.
- Reduce statistical power – more patients are needed to reach meaningful results.
- Delay approvals – regulators want clean, trustworthy data before approving a new drug.
In short, poor adherence can waste time, money, and even cause promising drugs to be abandoned.
Why old methods don’t work anymore
For years, researchers used pill counts, patient diaries, or verbal check-ins to measure adherence. But these methods are often inaccurate. Patients may forget to take their medication, misreport what they did, or even throw away pills to make it look like they stayed on track.
The result? Incomplete or misleading data. These methods can’t show when a patient took a dose or whether they took it at all.
A smarter way: real-time adherence monitoring
Thankfully, technology has moved forward. Today, we can use digital tools like smart pill bottles or electronic caps (as MEMS cap) that track every time the medication container is opened. These devices collect data automatically and show exactly when doses are taken or missed.
At AARDEX Group, we use MEMS (Medication Event Monitoring Systems) to give researchers real-time visibility into medication-taking behavior. This means:
- No more guessing;
- Early warnings when patients go off track;
- Tailored interventions to get things back on course.
How it helps clinical trials?
With accurate adherence data, researchers can interpret results more clearly by separating drug performance from patient behavior. This clarity supports smarter decisions, such as whether to adjust dose levels or modify sample sizes. It also helps reduce trial risk by identifying issues before they impact final outcomes. Additionally, real-time adherence insights ensure the trial aligns with modern regulatory expectations, including ICH E6(R3) and E9(R1).
This is part of a broader approach called Risk-Based Quality Management (RBQM), which focuses on identifying and addressing key risks throughout the trial.
Medication adherence isn’t a side issue, it’s central to the success of every clinical trial. Without it, data becomes noisy, results become unclear, and trials become riskier and more expensive. But with the right tools and strategies, we can monitor adherence accurately and take action in real time.
Investing in adherence monitoring isn’t just good science, it’s smart business. It helps bring better treatments to market faster and with greater confidence.
Contact us to learn more.
