Are your patients compliant, and is the data you’re collecting reliable? Are you going to need to enroll more patients due to uncertainty? If you’re conducting research, you might be encountering these questions right now. If you’re about to start a study, you should anticipate these questions.

Sponsors deal with myriad considerations in how to reduce overall risk and costs across a study, but managing the complexity of patient behavior must always stay in focus. Study teams have an imperative to ensure patients are well informed and prepared to participate in their own therapies.

The challenge of patient treatment adherence and retention can do a lot more than create delays and increase expenses during a clinical trial. When a patient does not comply with the treatment regimen, the integrity of the clinical trial data is at stake, and patient safety is at risk. Nonadherence can “lead to an underestimation of the efficacy of a treatment and dismissal of a potentially useful therapeutic agent.” If the research is on pain medication, and the patients are not adhering to the therapy, not only will the potential efficacy of their treatment be jeopardized, but there will be a downstream impact on how the patient reports pain to investigators, which results in bad data. Variances in data quality reduce the statistical power of the sample size, which results in enrolling more patients and delaying clinical trial completion timelines.

The rates of noncompliance have not changed much in the past three decades. However, a patient engagement strategy involving training and e-learning is one approach proving effective. Patient education can include information about conditions and treatments or how to report pain, for example. 

Re-recruiting patients is expensive and time consuming. A compliance-focused learning management system (LMS) resolves avoidable patient nonadherence in clinical trials that can result in having to find new patients to collect more reliable data.

Here are three ways a compliance-focused LMS can positively impact patient compliance during a clinical trial:

1. Delivery of Information and Learning Progress Awareness

   Learning is an administrative task for patients, and it needs to be made easy. They need exactly the essential information, precisely when they need it. Information needs to be prioritized so they can focus only on completing courses and keeping track of their progress. Targeted dashboards ensure patients get only the information they need, and they are not overwhelmed with choices. Every action they need to take should be at their fingertips. Questions like “What courses do I need to complete?” or “Are there any new courses I didn’t take yet?” or “How much more training do I have left?” should be answered for the patient so the learning process does not introduce new obstacles.

2. Simplification and Personalization

   When considering training, think small. Dedicating five minutes at a time, rather than half an hour to an hour, asks much less of the patient and makes learning more accessible. It also is encouraging, as these smaller doses of learning are more readily completed. Although typically used as a system of record (to “record” learning elements, courses, and learner statuses), today the LMS needs to work as a system of engagement. Without engaging the patient with e-learning, you can’t deliver on the real end goal—completed learning, knowledge retention, and treatment adherence.

3. Centralizing Learning Content

   Learning needs to be reinforced as well as updated. Information evolves and new e-learning content should be rolled out quickly to ensure everyone is properly informed. The ability to manage and track ongoing learning is essential. Your LMS approach needs to be more of a Learning Content Management approach so that as changes occur and e-learning is updated, those changes can be filtered across versioned content delivered in various ways, e.g., mobile devices, ePRO site tablets.

Informed patients are more likely to be compliant patients. They are more engaged in the process and better understand the implications for their own treatment and their role in the broader mission of clinical research and the future patients whose lives may be improved or even saved. The keys to doing this effectively lie in content brevity, personalization, ease of access, progress appraisal, and fluid information updates and distribution.

For more information on patient compliance and retention and compliance-focused learning management, contact us at info@trialinteractive.com or visit us at https://www.trialinteractive.com/globallearn.