The Dropout: Building Effective Patient Retention Strategies Early in Study Design
“The Dropout: Building Effective Patient Retention Strategies Early in Study Design” by Kate Bauer and John Ferraro was originally published in Labcompare. Click here to read the original article.
When sponsors design their clinical trials, the biggest factor to solve is recruitment – how and where do you find the right patient population to study? Without a patient population, there is no clinical trial. But finding the patients is just a component of the bigger research picture, as retention of those patients is equally, if not more, essential to the success of the trial and is an indicator of patient satisfaction.
We’ve observed many sponsors who have overlooked the significance of building retention design into their trial early on and ran the risk of timely and costly processes as a result of patient dropout without the proper mindset from the beginning. Fortunately, with the advancement of modern clinical trials that have incorporated hybrid, decentralized, and an array of technical components, retention design principles are more available and easier to implement. But that doesn’t mean research teams shouldn’t build in those retention principles just because their trial is decentralized.
In this article, we want to share context as to why designing for retention early on matters, outline major risks and challenges sponsors will likely encounter if they don’t build for retention and highlight solutions to navigate retention challenges. Ultimately, this process may require a shift in mindset and take more upfront planning, but the time spent will be in the sponsor and patient’s favor.
Plan for Dropout: Retention Oversight Concerns and Solutions
We’ve observed many clinical teams design recruitment plans into their protocol, but often leave out retention procedures before issues arise. And retention issues will inevitably arise in any trial. The problem with leaving out retention design is that clinical trial timelines are designed around recruitment with an anticipated or expected dropout rate. However, with enhanced recruitment – known as vetting – and increased retention, the dropout rate will likely decrease, and timelines (and budgets) may shrink. It is critical to understand that underestimating that the dropout rate can adversely affect timelines, budgets, and the health of the trial.
There are major risks and concerns to the trial participants (and their patients and families) if retention is only addressed when the trial experiences dropout to the point of critical risk. If the study is multi-phased, for example, previous participants are eligible for the additional phases. In this instance, keep the operations efficient by recruiting once and retaining the patients for future phases or periods. But this requires a shift in mindset.
To mitigate dropout risk, here are numerous retention best practices:
- Ensure proper screening and adequate vetting – this should include educating the patient of the assessments and procedures as well as why their participation matters. Vetting should include an honest assessment of availability and ability (i.e., time and travel as well as technology, frequency of assessments, check-ins, etc.)
- Provide factual study updates to patients – this will keep patients informed and engaged in the study
- Solicit feedback – this is a valuable tool to improve the patient’s experience, enhance retention, and improve the study. Solicit patient satisfaction and buy-in to generate a sense of connection to the trial patients by asking questions like “how can travel be better arranged, visits be better communicated, etc.”
- Give tokens of gratitude – for example, thank you notes, activities, and/or snacks for participants and/or companions during lengthy in-office visits, check-ins (i.e., text or via platform), and gifts (i.e., lunch box for a long day of travel, tote for carrying medication or supplies, etc.)
- Take time to understand the site staff – this is instrumental! Site staff are the study ambassadors and the direct link between the study and the patient. The site staff is also often on multiple studies, may have high turnover, and are busy, so keeping them informed and engaged is crucial to the happiness of the patient. Thank you notes, updates, and other forms of appreciation and engagement will remind the site staff they are valued, and their enthusiasm will in turn be felt by participants
- Close out the study with patients – the curve of efficacy. A patient’s time enrolled in a given study is really only a fraction of the entire study experience and closing out the study is a process that’s often overlooked. Sponsors and site staff often overlook the fact that patients may conclude their participation and never hear anything again about the results of the trial. Since there are many reasons why patients enroll – a chance to participate in a cure or treatment, to learn more about a condition, or to help future generations or members in their family – it’s critical to provide patients with information following their valuable contribution to give closure to their experience.
Decentralized and Hybrid Trials: Do They Allow for More Retention Options?
Patient retention and engagement has long been a challenge in clinical research, but decentralized clinical trials (DCTs) have had a uniquely positive impact on retention. In some instances, DCTs can make participating in research easier and studies more accessible to patients that are far removed from study centers. Access to trials becomes a bit less tricky with technology at the center of trials. And without the need to perform all assessments at a clinical trial site, sponsors can successfully recruit patients from greatly expanded geographic areas and “meet them where they are.”
But does this approach translate to the same ease of retention? Not necessarily so. In one aspect, implementing DCTs and hybrid trials gives sponsors an opportunity to engage trial patients like never before to assist in retention through creative and frequent communication, but implementing these modern DCT and hybrid strategies and tactics can potentially hinder the close face-to-face relationships that clinical trial site teams have with their cherished study participants.
Regardless of the trial – traditional site trial, hybrid, or DCT – sponsors still need to plan and design thoughtful retention strategies before the issues arise. Answering the question “as our trials become more decentralized, we lose that internal in-person team, so how do we weave that personal connection through all patient touch points?” may aid in those retention design best practices for clinical research teams.
Retention is critical for the clinical trial because it reduces time, costs, and overall burden to the trial’s operations. And for the patient perspective, it keeps them understanding how they fit into the trial’s goals and mission, feeling appreciated, valued, and aware that they’re a part of that trial’s big picture.
As clinical research teams are designing their trial protocol, it’s essential to keep a focus on the patient perspective and understand reasons why patients may drop out, so their design is mindful and builds in retention principles to ensure the health of the trial and the satisfaction of the patients.
About the Authors: Kate Bauer is a clinical research professional and Registered Dietitian with over 10 years of experience in clinical trials. She offers extensive experience in opthalmology and nutritional supplement trials and holds previous experience as a consultant, providing competitive intelligence briefs to pharmaceutical companies.
John Ferraro is a freelance clinical operations executive with extensive experience in designing and overseeing decentralized clinical trials.