Electronic Compliance Monitors like the Med-ic ECM can be utilized in clinical trials in a variety of ways.

The simplest application is where compliance monitoring is used to replace medication diaries and pill counts. The advantages are that the data are more accurate (pill counts and medication diaries are notoriously unreliable for determining patient compliance) and that there are cost savings due to the elimination of time-consuming work by the trials monitor. In addition, the Med-ic ECM incorporates the technical controls to support 21 CFR Part 11 compliance without active input by the trial monitor.

It is well-known that education targeted at those who require it is more effective than "broad stroke" education. Although most clinical trials use education to encourage patients to be compliant, it is largely of the broad stroke type. Patients whose medication diaries or pill counts suggest poor compliance may receive targeted education, but it is known that the data obtained by these means are not accurate. In many clinical trials, education can be targeted at noncompliant patients at intervals during the study. With electronic compliance monitoring, noncompliant patients can be indicated to the trial monitor with little extra effort, the data on which the targeting is based will be accurate, and the integrity of the study design will not be jeopardized.

One strategy for increasing patient compliance in clinical trials is to run a placebo pre-trial to determine which patients are compliant. Those demonstrating non-compliance can be targeted for education, and the cohort retested. Once group compliance is at an acceptable level, the patients can be entered in the study. In a variation of this, persistently noncompliant patients might be removed from the sample although this may have profound negative implications for the analysis of the study data and for generalizability of the results to the population of interest.

As our understanding of how non-compliance relates to other factors of interest in clinical trials increases, it may prove possible to co-vary out non-compliance as a factor during statistical analysis of study data.

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