Patient recruitment expenses represent a large portion of clinical trial budgets, averaging ~$640,000 per trial. Drop-outs, which can be as high as 19% for late-phase trials, and patient non-adherence are therefore of concern to trial sponsors. Both result in reductions in the overall sample size, compromising the statistical power of the study or delaying the study to accommodate additional patient recruitment. In fact, 85% of clinical trials with some patient populations fail to retain enough patients to confirm medical efficacy, and nearly 25% of studies do not meet their planned enrollment timelines.
Why do patients drop out of clinical trials after making it through the enrollment process? Some common reasons include:
- No motivation to continue the study
- Study did not meet expectations
- Stressful site visits
- Lengthy duration with slow-moving signs of condition improvement
With the ongoing COVID-19 pandemic, patient safety is also a concern, affecting not only patient choice to continue participation but also overall trial conduct.
To address these issues, sponsors and CROs must employ patient-centric solutions to help keep patients engaged and informed throughout the trial. In this blog post, we’ll cover ways to prevent attrition and improve communication with patients.
Recruit Motivated Patients
An important first step to patient engagement should occur even before the patient is enrolled — making sure each patient is a good fit for the trial and is motivated to participate. Using validated questionnaires and trained personnel, patients can be screened and qualified prior to enrollment.
Leverage Digital Technologies
On average, people check their cell phones 150 times per day, making digital apps and SMS messaging perfectly positioned to help alleviate stress related with site visits and expectations about the trial. An app allows patients to easily access information about the study, to integrate clinical trials into their daily lives and with the right features, keep them engaged.
App features should focus on the wants and needs of participants. We suggest:
- Journey Overview – Ensure full understanding of the clinical process with a simple overview of the trial calendar and key milestones.
- Event Descriptions – Provide detailed insights with descriptions of site visits including procedures and directions.
- Resource Library – Enhance patient knowledge and awareness through a repository of trial and disease-related information.
- Simplified Interface – Create an engaging patient experience using game design elements and patient-friendly flow.
- App-based Adherence Reminders – Help keep patients in compliance with reminders for medication intake and study appointments.
- Site Connection – Provide a direct patient-site connection so the sites can push motivational messages to their patients.
In addition, customized SMS messaging for assessment and visit reminders can increase compliance by 75%.
Both an app and SMS messaging can be used to update patients on the status of temporarily stopped trials, including the impact on any treatment they’re receiving, which could play a role during COVID-19. If the trial will be stopped for a long period of time, periodic SMS messaging can keep the trial on the patient’s radar so they are ready to resume when the trial starts again (if possible).
Remotely Monitor Patient Adherence and Management
Sites have an important role in making sure that patients stay involved. When you enable sites to remotely monitor patient adherence and management, they can proactively identify patients that are not completing activities or missing visits. A site personnel administration tool that simplifies site workflow and decreases work related to patient tracking will reduce the burden on site staff. Some features to consider include:
- Activity Feed – Site staff can make informed decisions on retention efforts through a real-time feed of patient activities such as medication reporting and visit completion.
- Automation – Protocol activities that are pre-programmed and automatically populated at activation make monitoring very easy.
- Participant Overview – A simple overview can provide patient insights, and management tools enable patient notifications, calendar and status.
Improved patient engagement results in better protocol compliance, reduced variability and improved retention. Consequently, a larger, effective sample size maintains adequate precision and statistical power for reliable conclusion of study results. Download our infographic and watch the video to learn how Trialbee’s recruitment and retention services can reduce drop-outs and improve patient engagement.