Monitoring Medication Adherence Electronically: Considerations and a Case Study
Year of Publication
Society for Clinical Trials 35th Annual Meeting
The validity of results in a clinical trial evaluating drug efficacy is highly dependent on participant adherence to the prescribed intervention. Non-adherence can result in erroneous or inconsistent conclusions. Monitoring adherence in a clinical trial setting is common but can be challenging. There is currently no industry standard for this process, although common practices include research staff performing a pill count and participant selfreport. Because neither of these approaches is ideal, electronic devices have been developed to provide a more accurate accounting of adherence. Examples of methods to electronically monitor medication adherence include eCaps, electronic blisterpacks, multicompartment smart pill boxes, digital swallow pills, and dose text or video interaction between the participant and research staff. Selecting the correct device for a clinical trial is vital to its success. Considerations include cost, portability, durability, ability to label per regulations, ease of use for the research staff and participant, user-friendly software to transfer data, ability to provide participant feedback, and lead time for filling the device with drug. Important factors for a trial centrally coordinated by a data center include availability of technical support, structure and content of the output data set, ease of data retrieval, and ease of integration with an electronic data capture system (EDC). In a recent study conducted by the Clinical Trials Network of the National Institute on Drug Abuse, an electronic adherence monitoring cap (eCap) was used. Adherence was determined by recorded times and dates of the eCap bottle openings. These openings were integrated with EDC and used to electronically calculate payments to participants for good adherence. Computing the adherence level and reimbursement was beneficial to the research staff due to strict time windows for medication dosing and a complex reimbursement algorithm. The benefits and challenges of incorporating this electronic medication adherence monitoring will be discussed.