Patient recruitment is always a concern in clinical studies. More than half of clinical trials face challenges in recruiting participants. The National Institutes of Health has found that in some study types, the percentage of trials struggling with recruitment can reach 85%.
Of all types of clinical trials, perhaps the ones that suffer the most from this issue are those focused on rare diseases. The eligibility criteria for these trials are narrow, and the very nature of the diseases means that there will be fewer potential participants to start with.
Additionally, potential participants could be spread throughout the country, making it logistically difficult to coordinate specialized assessments. For clinical operations and CRO study teams, this translates into missed enrollment timelines, screen failures, and site burden, aside from the travel expense participants face.
All of these factors place a heavy burden on participants. If the burden becomes too great, then dropouts occur, triggering further recruitment struggles. To meet recruitment timelines, sponsors, CROs, and site teams must address the pivotal issues these participants face through protocol-adherent field execution and single-call accountability. Turning to the right clinical trial recruitment strategies can make this possible.
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The Rare Disease Recruitment Challenge: Geographic Scarcity & Patient Burden
Understanding the challenges of rare disease study designs is essential to finding solutions. When dealing with rare diseases, there are inherently fewer patient populations to choose from. Patient registries may be available, but even people with the rare disease may not meet all criteria. Inclusion and exclusion criteria are more complex in these trials.
Further, research participants may be located throughout the country, or there may be remote pockets in various regions. Underserved and rural areas often lack the facilities or ophthalmic professionals needed to conduct highly specialized studies, either. This impacts patient recruitment and retention because it would require patients to travel long distances for their assessments.
These trials don’t involve healthy volunteers. Traveling for long distances may not be physically feasible, aside from being expensive.
Studies also have to compete with physician referrals and access to standard care. Participants may be more focused on getting regular care from their healthcare providers than on being in a trial.
Additionally, even if the trial can reach its recruitment goals, retention could become an issue. Dropout rates may be much higher if participants face serious travel burdens. It can be very expensive to lose participants and have to recruit new ones. High dropout rates affect the morale of the remaining participants, too. It could trigger a mass exodus, leaving your study floundering.
How Point-of-Need Delivery Reduces Recruitment Friction
One of the most effective clinical trial recruitment strategies for rare disease studies is point-of-need clinical execution. Instead of having a single central site that participants must travel to, this approach delivers specialized ophthalmic assessments closer to where participants are located. Mobile clinics can visit community centers, nearby health facilities, and even neighborhoods.
Having a single centralized site can cause delays in various ways. It may not be possible to meet the strict deadlines you set for the study, which could lead to data integrity issues. But patient advocacy groups and CROs have noticed the change that point-of-need delivery can bring to these studies. It reduces the travel burden by up to 80.6%.
Studies with point-of-need delivery require participants to travel, on average, 12 miles. For studies 20/20 Onsite has participated in, we've found that participants of standard studies have to travel an average of 67 miles. For people with rare diseases who may struggle to see, traveling long distances every time they need an assessment is difficult or even impossible.
This setup also assists with retention. Dropout rates in standard trials is 30%. In point-of-need delivery models, that rate falls to 9%. Not needing to invest so much time, energy, and money into getting to the trial site naturally increases participant satisfaction.
Pre-screening procedures can be performed accurately, too. Informed consent documents can be given without delays, along with materials to enhance patient education. Doing so early in the process gives patients time to understand what will be asked of them. If they have a clear idea from the beginning, then they are less likely to drop out later.
The principal investigator does not have to worry about protocol deviations that could put the study in jeopardy, either. Point-of-need clinical execution helps participants meet every appointment, supporting ocular endpoint protection and data quality. Missing even one assessment could affect data collection, putting your study at risk.
These clinical trial solutions enable the target audience for the studies to participate without worrying about significant travel burdens. They may be more likely to sign up on time to meet recruitment goals if they are not hesitant about participating in assessments.
When Geographic Barriers Don't Stop Enrollment: The AGTC Gene Therapy Trial
Clinical trial recruitment strategies using point-of-need delivery have been successful in numerous studies, including the AGTC gene therapy trial. Not only did this trial involve ophthalmic assessments, which are notoriously challenging, but it also occurred during the pandemic.
Despite these obstacles, the trial enrolled participants from 24 states and collected data from more than 150 assessments. The retention rates remained high during the trial. It had a 97% satisfaction score from participants, which is much higher than average. Enrollment was fast, and retention remained high.
Because these studies involve diseases that impact a small percentage of the population, travel challenges are among the most serious obstacles. Point-of-need clinical execution brings specialized ophthalmic assessments to the participants. This protects endpoint integrity and data quality while easing appointment adherence.
These point-of-need assessments often offer virtual pre-screening services, too, eliminating the need for in-person evaluations. That alone removes a significant burden from participants.
Building Recruitment Strategy Around Geographic Access
For the best results, clinical trial recruitment strategies for rare disease studies should primarily focus on understanding potential travel issues participants may face. As soon as the team begins developing the trial’s protocols, ways to ease travel burdens must be considered. Assessing geographic burdens as early in the prep process as possible can save both time and money.
Look at the areas where the participants are located. Are there facilities available where the assessments can take place? Rural communities, for example, may not have dedicated ophthalmic centers where some of the trickier endpoints can be conducted.
Clinical trial recruitment strategies should also include engaging an execution partner with specialized ophthalmic assessment capabilities. This partner must integrate into existing sponsor, CRO, and site systems while providing single-call accountability and protocol-adherent field execution.
Make sure to incorporate point-of-need delivery into enrollment strategies immediately. This makes it easier for the entire team to get on the same page from the start. It also encourages more participants to sign up.
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Executing Specialized Ophthalmic Assessments in Diverse Geographies
Mobile vision clinics can be deployed across underserved areas throughout the country. It makes no difference if the area lacks appropriate healthcare facilities for the assessments to take place. Participants will not need to worry about performing the assessments themselves, which is not a viable option for most trials.
Instead, mobile vision clinics will bring the necessary, calibrated equipment to the area. These clinics also provide trained technicians who can perform the assessments correctly.
It's essential that each assessment be completed using the same protocols to avoid deviations and maintain validated regulatory rigor. Protocol-adherent field execution makes that possible. All participants will have access to trained ophthalmic technicians who ensure consistent, specialized ophthalmic assessments.
These technicians also make the trial simpler for sponsors and site teams. They can integrate seamlessly while providing the necessary support. With mobile vision clinics, you also have access to real-time data. It can be challenging to accomplish this when dealing with one central site or when running a fully virtual trial.
Vitally, point-of-need clinical execution does not try to replace the trial structure. Instead, it integrates into existing sponsor, CRO, and site systems and enhances the inherent structure, making it more efficient and easier for participants.
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Build Your Rare Disease Recruitment Strategy: Expert Protocol Review
If you are in the planning stages for a rare disease clinical study, understanding the factors that impact recruitment and retention can serve you well. Not having a clear plan to ease travel burdens for participants can lead to high dropout rates. That can lead to serious delays, which translate into mounting expenses.
You must get an overview of the geographical and logistical barriers your study could face. An expert protocol review can offer insight into where your patient base is located. These reviews can give you a clear idea of whether the target base could manage a centralized trial or if mobile options are better.
Whether you're beginning your first trial or working to rescue a study that is already off-track, consider how point-of-need clinical execution can help you overcome barriers from day one. At 20/20 Onsite, we provide specialized ophthalmic assessments, single-call accountability, and protocol-adherent field execution that meet your trial's exact needs.
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