Boost clinical trial retention with participant engagement and adherence patterns
Clinical trial participants are among a study’s most valuable assets – which is why Sponsors & CROs are increasingly investing to keep them on board, on track, and on the drug.
Clinical trial participants are difficult, expensive, and time-consuming to recruit, yet dropout rates are notoriously high across therapy areas and indications.
People cite the financial and logistical implications of attending site visits, and a lack of understanding of the trial protocol as barriers to keeping on track.
Whatever the motive, the impact is huge. The trial can become underpowered and may not have enough data to effectively demonstrate either statistically significant clinical benefit or the product’s safety. Either of these outcomes can be devastating for a clinical development program.
For decades, sponsors and CROs have attempted to solve the problem by simply recruiting replacement participants. But this strategy delays trials and is extremely expensive, and, critically, is fast becoming unfeasible.
The rise of the personalized medicine era means products are more complex and more targeted than ever before, meaning developers have a much more limited pool of potential candidates to draw from.
Retaining the initial intake of enrolled participants, then, has never been more financially or scientifically important.
Participant Engagement Strategies
Patient/participant engagement or giving participants everything that they need to become and remain invested in the process could be the key to solving the decades-old retention challenge.
At enrolment, for example, teams can work with people to ensure they understand exactly what is expected of them, and what they can expect from the trial and make sure consent forms are written in a way that accounts for varying levels of health literacy. This upfront effort means people go into the process with their eyes wide open, and don’t experience challenges that lead to dropouts later on.
To be successful engagement strategies must run the length and breadth of the study. Teams must constantly “check in” with participants to ensure they are on track and be able to offer support where and when it is needed.
Achieving this level of two-way dialogue without placing additional stress on the site staff is not easy. That is where using medication adherence as a barometer of engagement can help.
Medication adherence is widely accepted as a marker of engagement with disease management in long-term conditions, but the approach has just as much to offer in clinical trials.
Erratic medicine-taking behavior and non-adherence can signal decreased engagement with the study and offers cues on poor product efficacy, intolerable side effects, or administration problems – all of which can result in poor retention.
Using Medication Adherence as a Barometer of Patient Engagement
Measuring adherence has, traditionally, been something of a challenge. Validated adherence measures have been few and far between, and those that do exist are non-standardized and imperfect.
And even when sites can establish non-adherence, what should they do about it? The reasons for poor adherence are as multiple as they are complex. There is no one size fits all solution, and any intervention must be personalized to the drug and the trial participant.
Digital Adherence Monitoring, however, is different. It combines connected packaging and powerful analytics to measure and help site teams manage medication adherence. Rather than relying on biased, subjective methods, such as pill count or self-report, it provides the objective, robust information that site teams need to spot the participants that may need additional support to stay on track with the dosing regimen.
Studies have shown it is 97% accurate, compared to 60% for pill counting, 50% for healthcare professional rating, and just 27% for self-report.
How Does Digital Adherence Monitoring Work?
Digital Adherence Monitoring can improve recruitment, by reducing the burden that may put people off enrolling in the first place, and improve retention, by helping teams to keep people engaged in the study.
Smart packaging, such as connected blister packs or pre-filled syringes, for example, automatically record administration, compiling a dosing history with no additional input required from the participant.
The information captured by the connected package is securely transmitted to a cloud-based platform, which provides a sophisticated analysis of medication-taking behaviors, and creates powerful visualization and focused feedback for study teams and participants alike.
Study teams can use this information to spot people who may need additional support, and deploy personalized interventions when necessary.
It is an approach that works – the closed feedback loop of active monitoring and targeted action can increase engagement, resulting in an up to 50% reduction in dropouts.
Invest in Patient Engagement, not Participant Replacements
With the cost of recruitment accounting for a large proportion of the estimated $314 million to $2.8 billion, it takes to develop and bring a new medicine to market, investing in retaining the initial participants makes financial sense.
Digitally monitoring medication adherence offers a window into the engagement. It provides a complete understanding of the behaviors and risk indicators that matter most for subject engagement and gives study teams the tools they need to take action when necessary.
Free Strategy Paper: Considerations for Achieving Optimal Adherence Monitoring
Our Scientific Lead, Bernard Vrijens, has just published a new strategy paper that’s jam-packed with considerations for achieving optimal adherence during trials. Click the button below to get your free copy!
About the Author
Bernard holds a PhD from the Department of Applied Mathematics and Informatics from Ghent University, Belgium. As Scientific Lead at AARDEX ® Group, Bernard oversees the research and development of sophisticated analytical methods for monitoring participant medication-taking behaviours.
Along with providing guidance on adherence to Pharmaceutical, BioPharma, and Academic organizations, Bernard is a founding member of the International Society for Patient Adherence (ESPACOMP) and is an active member of several EU and US-funded consortiums that focus on adherence. Having co-authored several book chapters, over 100 peer-reviewed scientific papers, Bernard is considered an expert in his field.