When sponsors and their sites don’t meet their clinical trial enrollment goals, time and resources aren’t the only things lost. Patients who might be eligible for the trial but haven’t yet been identified or enrolled miss a big opportunity to receive an investigational product and help move therapeutic development forward. Possible medical breakthroughs are stalled, so future patients who could benefit from this product won’t get to access it on the market when they need it most.
So how do sponsors work to increase patient enrollment in clinical trials? Here are six strategies.
There can be a lack of awareness of clinical trials studying specific indications, especially if that information is not readily available online. Consider the internet a valuable resource for both patients and physicians searching for therapeutic opportunities. A clinical trial recruitment website can serve as an easy launching point for sharing information about the trial and for providing initial steps for engaging with that clinical trial. Higher website engagement can lead to higher patient enrollment for clinical trials.
On your trial website, consider including:
Traditionally, patient recruitment happens one trial at a time and recruitment starts from zero with each new trial. That means the thousands of patients who were recruited for one trial, but weren’t ultimately eligible exited their patient journeys, even though they could potentially qualify for another trial with the same sponsor.
Establish cross-trial clinical trial patient recruitment methods, which can lead to more randomizations from the same recruitment spend. To do this, build out a patient database that catches patients who weren’t eligible for one trial, to be considered for additional trials. With the same recruitment effort, you can recruit patients who may qualify for one or more other trials.
Patient slot allocation, particularly during early-phase trials, can be slowed by factors such as an excess of tools from emails to spreadsheets, the lack of a single location to monitor slot updates, and manual processes like email and phone submissions. Time, efficiency, and accuracy can all be lost, and eligible patients can fall through the cracks.
Choose a patient enrollment management platform that connects you with your sites – and that includes capabilities for cohort management in clinical trials. When you are able to easily identify new or updated slot requests and immediately review and take action on that request in one place, you can increase patient enrollment for your clinical trials while reducing communication time.
Improving patient centricity in your clinical trials can take several forms, from ensuring convenient and clear communication between patients and sites, to reducing patient burdens and barriers to enrollment. When you track subjective patient concerns about trial participation (like perceived risk) as well as objective barriers to enrollment (like an I/E criterion with a high failure rate), you can identify opportunities to better support patients during the recruitment and enrollment process. Why this matters: If you help make the recruitment and enrollment process easier for patients who are actively interested in participation, you’re more likely to enroll every enrollable patient – and faster.
To address barriers and concerns, you need to know what those barriers and concerns are. Set up a formal pre-screening process with your site teams that includes:
With this information at your fingertips, you can strategically address issues sooner that are preventing interested patients from enrolling.
Site teams are often short-staffed and overloaded with work to begin with. Trial factors that can contribute to clinical trial site burden include:
When sites are overburdened, they’re less efficient. When they’re less efficient, enrollment numbers can suffer, and timelines can slow down. Find ways to support your site teams, from writing more clear protocols, to providing online pre-screener forms, to setting them up with technology solutions that send patient referrals right into your sites’ databases.
When an enrollment goal might be missed, it’s common practice to update the enrollment timeline to accommodate the delay. But this recurring practice leads to lost time, effort, money, and patient opportunities to enroll. Consider what data and insights you can pull from your current clinical trials for data analysis to inform better trial planning.
For example, can you obtain recruitment data from your sites to assess the ROI of each recruitment channel and to consider obstacles to patient progression through the funnel? What can be addressed? Patient travel constraints in specific geographies? Patient perceptions of study burden? Use this analysis to strategically plan for your next trials, eliminating barriers in advance to increase enrollment.
Whether you’re enhancing sponsor-to-site communication, or supporting a patient database build-out for cross-trial recruitment, or identifying patient burdens to address, it’s impossible to accomplish these tasks without the right technology. That’s why OneStudyTeam built a cloud-based suite of software solutions to support sites and sponsors in their work to accelerate clinical trial enrollment timelines and to increase patient enrollment numbers in clinical trials.