The average patient drop-out rate in clinical trials is an alarming 30% according to Forte Research. If this percentage is already jaw-dropping to you, then you will be shocked by the next one.
The investigational medicinal product waste generated from patient non-adherence to treatment protocol, according to PubMed, ranges between 25 and 50%.
Yes, that is bad.
But first, what do we understand as patient engagement in clinical trials?
Patient engagement in clinical trials means making an active effort to involve patients at every step of the clinical trial process. This includes listening to their thoughts, preferences, and needs to make sure the trial is actually patient-centric and meaningful. All stakeholders of a clinical trial (Sponsors, investigators, extended site staff, caregivers, patients, advocacy groups, etc.) work together to design the studies, recruit patients for these studies and then, keep the patients interested and motivated in the study. Patient engagement also means gathering and using patient feedback on their experiences and sharing the learned results with them, creating a collaborative, transparent and close relationship.
Such an idyllic scenario the one we just pictured, isn’t it? However, data shows reality is far from it.
Why do clinical trials struggle to retain patients in clinical trials?
There are a few reasons why these patients drop out of the study. From logistical challenges, trial burden, disease progression, costs, side effects and safety concerns to lack of appreciation and engagement. But let’s focus on what we can do about it.
How can you increase the patient engagement rate in your clinical trials with Trial Online?
There are many tools in a clinical trial, some of them are required and essential, others are additional support, but the main tool designed specifically for patients is the Electronic Patient Reported Outcomes (ePRO) system. The ePRO captures the patient’s direct responses to questionnaires or surveys on an electronic device (smartphone, tablet, computer) instead of a paper document. By using an electronic device, it is easier for the patients to record their experiences in real-time, which provides investigators with more timely and reliable information for clinical decision-making and research purposes.
For an ePRO tool to be successful, we need the patients to register all the data required throughout the full length of the clinical trial, with a compliance of 100% or the closest possible to it. But in order to have 100% compliance, we need patients to be engaged and motivated to respond to all questionnaires and complete all tasks.
Trial Online three gamification elements to improve engagement and feeling of appreciation
Tailored notifications. The ePRO should allow all types of notifications to be sent to the participant’s electronic device. From clinical trial protocol-related guidance to treatment instructions, and upcoming visits information. The same communication channel could be used to motivate the participant’s activity in the study by sending personalized messages that guide, train and support the participant whenever needed.
Tailored awards. The ePRO tool should show appreciation for the efforts of the clinical trial participants to complete all protocol-required activities and tasks through awards, motivation is high throughout the study to provide those needed key data points at all times.
Study progress. Participants should see their progress status at all times in the ePRO: time and effort invested and time and effort pending to be invested until study completion. Knowing the progress and where it stands in relation to study completion, boosts motivation.
Patients play the most essential role in clinical trials and their continuous and engaged participation is crucial for regulatory approval and the generation of valuable data for understanding disorders and developing effective treatments. Technology has provided innovative solutions to enhance the experience of the clinical trial participants, but it is equally important to ensure that patients still are engaged and appreciated throughout the study. Trial Online ePRO has embraced these three gamification elements and the results speak for themselves.