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Address Medication Non-compliance to Reduce Trial Failures

August 30, 2016
Posted by: Tina Schlecht, PharmD, MBA

Twenty years ago, Dr. John Urquhart published a paper titled, “Patient Non-Compliance with Drug Regimens: Measurement, Clinical Correlates, Economic Impact.” In his paper, Urquhart raises the alarm about patient non-compliance with medications and its implications for clinical trial outcomes. He argued that, by ignoring under-dosing due to medication non-compliance, sponsors can draw the false conclusion that a treatment is ineffective. Sponsors can also arrive at erroneous conclusions when medication non-compliance leads to adverse events (1).

Since publication of his paper, new trial designs and methods of statistical analysis have helped indirectly to address the issue. However, medication compliance rates within long-term clinical trials continue to languish at nearly 60 percent (2).

Are the failures of today’s clinical trials due to poor drug candidates or inadequate trial designs? Or are they due, in part, to medication non-compliance and misunderstandings about the study drug and protocol requirements?

“Drugs don’t work in patients who don’t take them.”
C. Everett Koop, former US surgeon general

Medication non-compliance is a multi-faceted issue. There are a variety of reasons for non-compliance and patients can often be non-compliant at different times and for different reasons (3). In order to help patients become and remain compliant with the study drug and its requirements, sponsors must provide and promote thorough and consistent educational practices for each patient receiving medication. The teach-back method, when combined with motivational interviewing techniques, has demonstrated positive results in improving patient compliance and providing patients with the support they desire. In fact, pharmacists have been using a version of the teach-back method with great success since the Indian Health Service first developed this technique in the 1970s (4).

The next time a report indicates a poor interim result or a clinical trial failure with an unknown cause, consider Dr. Urquhart’s concerns about medication non-compliance and its effects on trial outcomes.

1. Urquhart J. Patient non-compliance with drug regimens: measurement, clinical correlates, economic impact. Eur Heart J. 1996;17 (Suppl. A):8–15.
2. Robiner WN. Enhancing adherence in clinical research. Contemp Clin Trials. 2005;26(1):59-77
3. Cutler, D., Everett, W. Thinking Outside the Pillbox — Medication Adherence as a Priority for Health Care Reform.
N Engl J Med 2010; 362:1553-1555.
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