Smart Medication Adherence Monitoring in Clinical Drug Trials: A Prerequisite for Personalised Medicine?

The current era of personalised medicine promises us medications tailored to the individual patient, minimising adverse effects, and maximising effectiveness. Yet, medication is only effective when taken as prescribed, which in the ‘real world’ turns out to be a major challenge. Indeed, WHO and OECD estimate that one-out-of-two patients with chronic diseases does not use their medication as prescribed. In Europe alone, non-adherence is estimated to annually contribute to the premature death of 200,000 patients and excess healthcare costs of €125 billion. Contrary to what is often assumed, the non-adherence problem is not exclusive to ‘real-world’ patients, but it also influences the strictly regulated setting of clinical drug registration trials. Of every hundred trial participants, four do not initiate a study drug. Each study day, 10–12% does not take their medication while still on treatment. In long-term studies, after one year, almost 40% of trial participants have stopped taking their medication. Novel digital adherence monitoring devices may offer a solution for patients who tend to forget their medication and for trial regulators to have granular data on the exact timing of medication use.

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