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Can decentralized clinical trials solve attrition?
Early research suggests 'yes.'
Mar 15, 2021
Meeting recruiting goals is always an important factor for clinical trials. But even when the most effective recruiting efforts are not balanced with strategies to engage and retain those patients, it will put the trial results at risk. When patients drop out of a trial, it not only creates data gaps, it skews the overall patient population and can lead to biased results.
Patient attrition has always been a challenge in clinical research, but the use of decentralized clinical trials (DCTs) may help sponsors overcome attrition problems. DCTs allow sponsors to create trial experiences that are less burdensome and more equitable to patients with diverse socioeconomic backgrounds and care needs.
When we combine the use of these models with direct feedback from patients about what would make trial participation a meaningful care option, it can bolster retention and greater engagement between patients, investigators and sponsors.
Travel burden
Research shows that some of the most common causes of attrition in clinical research are time related: specifically, the time required to participate in the trial activities and the time it takes for the participant to travel to the research site.
Many trial participants travel more than 25 miles to their trial sites. And in some communities that distance can be more than double. If a trial requires frequent visits, the time and cost of meeting that schedule can become too much to continue.
That quickly erodes recruiting and retention goals. One study of attrition in genomic trials found that enrollment and retention rates decrease by 10 percent for every additional 30 miles patients have to travel.
Patients experiencing more complications or fewer benefits from a treatment may also be more inclined to drop out of a trial, which can introduce outcomes bias to the data. Add in competing demands from work, childcare, and day-to-day activities – particularly for patients dealing with a medical condition – and they may view the trial as simply too burdensome to complete.
DCTs can eliminate many of these burdens by building trials around patients needs. When sponsors incorporate e-diaries and e-consent forms, telehealth visits, and home health staff and local labs into the trial experience, it eliminates the need for excessive travel and reduces the time patients have to invest in the process.
To make the most of DCTs, sponsors need to consider what impact trial design decisions have on making a trial more or less convenient, because the more convenient it is to participate the more likely patients are to stay committed until the end.
These decisions don’t just benefit patients. By making trial participation easier and less burdensome, engagement and retention can improve among all patient demographics, resulting in more robust data in less time, and with a lower risk of bias.
Better for everyone
Several studies exploring methods to improve recruiting and retention point to the benefits of virtual elements – such as electronic consent, patient e-diaries, chat support and telemedicine – to meet recruiting and retention goals.
One 2018 study comparing recruiting and retention rates in conventional vs. DCT trial models in Europe, found that the DCT arm delivered a 300% greater rate of enrollment, and a significantly higher rate of retention compared to the conventional arm (89% vs 69%). “The findings of this pilot, when considered together with the literature supporting technologies such as electronic informed consent, electronic patient reported outcomes (ePROs) and telemedicine, as well as information published on trials conducted remotely, demonstrate that the decentralized site model is a functional buildup of the evolution of trends seen in clinical trials today,” the authors conclude.
Several other reports found similar results. In the genomic trial study mentioned earlier, the authors found that using telephone surveys to fulfill required study activities, rather than making them travel to the site for the final survey, led to high rates of retention at the end of the trial.
And in a review of cardiovascular disease patients participating in a longitudinal study, researchers found that by offering home-based follow-up visits to study participants who couldn’t or wouldn’t come to the site, they were able to keep 61 participants (25% of the enrollees) who would have otherwise dropped out. This eliminated the risk of attrition bias in the data, as the participants requiring home-based follow-ups were more likely to have two or more complications than those who came into the site. The data collected through the follow-up visits enabled them to achieve statistical significance the main trial outcome. “Without home follow-up, the complications sustained by these participants would not have been counted in our study results,” the researchers found.
Getting started
The rapid adoption of DCT elements during the COVID-19 pandemic, often implemented to mitigate site closures, will likely lead to more evidence showing the positive impact telehealth and other virtual technologies can have on clinical trials recruiting, retention, and diversity/inclusion goals.
Simply put, DCTs make trial participation easier for participants and give them fewer reasons to drop out, which can result in better, faster, and more consistent data. For sponsors struggling with retention issues, offering patients a way to participate in clinical trials from the comfort of their own homes could offer a powerful solution for the future.
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