Management of Patient Adherence in Clinical Trials Using Electronic Monitoring
Automatic adherence measurement through electronic compilation of drug dosing histories plays a key role in achieving and maintaining patients’ adherence to prescribed therapies.
Adherence to prescribed medications is notoriously poor for all chronic diseases, and an accurate dosing history is essential both for optimal patient management and to understand the full effect of prescribed medications. Unfortunately, most methods for measuring medication adherence are inaccurate and employ data-sampling that is far too sparse to be useful. The exception is automatic adherence measurement through electronic compilation of drug dosing histories, which provides the most detailed, reliable and economical measure of a patient’s adherence.
The need for reliable data
Doctors, nurses, patients, and drug regulators are absolutely dependent upon having reliable data from clinical trials to define the dose-requirements and dose-dependent benefits as well as risks of drugs to be used in medical care. Two main things that go wrong in clinical trials of new and established drugs are that some patients skip, delay or take extra doses of the test medicine and some patients completely stop taking the test medicine. Most of these deviations from the trial plan are not communicated to the trial staff and thus go unrecorded and unanalyzed. Without reliable data on when doses were taken or missed by trial patients, the results of drug trials can be misinterpreted, leading to overestimated dosing requirements or erroneous conclusions about whether a new drug is effective when dosed correctly.
Electronically monitored packaging for trial success
Drugs in clinical development, when taken correctly, work well in some patients but not others. Naturally, untaken drugs don't work in anyone, so it is important to have reliable data on patterns of missed doses by all patients in ambulatory trials. Since 1988, electronically monitored packages have provided accurate records of doses taken and doses missed by patients during clinical trials. The use of smart packaging is reported in more than 600 peer-reviewed, published research papers that describe uses of Medication Event Monitoring System (MEMS®) in a wide variety of clinical trials in many therapeutic areas. MEMS smart packages have been used for all types of drug form factors – oral solid dosage forms (in bottles or blisters), injectables, inhalers (pumps & sprayers), and ointments or creams in tubes. The error rate of MEMS monitoring is <3% in multiple published studies. Thus, despite the fact that the method of measurement is indirect, MEMS monitoring gives a highly reliable measurement of the time that the patient took the prescribed dose of the prescribed drug. Each MEMS monitor has a 3-year functional lifetime of internal storage of the time-series of dosing times, which can be read out simply and reliably.
Measuring patient adherence on a personalized level
A key lesson learned from this work is that three factors are crucial in assuring that patients achieve and maintain correct dosing. First, patients need to be fully informed about the correct dose and dose-timing that are essential for best clinical results. Second, patients need to be motivated to dose correctly. Third, patients need to know when and by how much their dosing history is deviating from the prescribed dosing regimen. Feedback of discrepancies between prescribed and actual dosing times is a statistically effective motivator.
A recent study found that providing patients with feedback about their own adherence patterns and discussing this information with a healthcare provider makes more of a difference in behavior than any other adherence intervention – increasing adherence levels by nearly 20 percent. This approach is best realized in clinical trials in which electronic monitoring methods make such feedback possible. The U.S. Food and Drug Administration (FDA) recently issued draft guidance encouraging the use of electronic packages to monitor and encourage medication adherence. Conclusions from these programs – especially the impact of non-adherence on treatment efficacy and safety – can also be used to determine how best to develop and incorporate adherence solutions into clinical care.
Driving patient adherence to protocol-specified or prescribed dosing regimens is an ongoing challenge. Only by measuring individual patient adherence patterns can clinical researchers fully understand how to best to achieve and maintain patients’ adherence to prescribed therapies.
John Musaus is the Global Head, Electronic Adherence Solutions at MWV Healthcare.
Bernard Vrijens, Chief Science Officer of MWV Healthcare is presenting insights from clinical trial data based on in-trial uses of electronic adherence monitoring, collected from more than 500,000 patients over the last 10 years, at Patient-Centered Trials Conference, September 4-5 2014 . For more information on his presentation, click here.
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