A recent study by WCG highlighted some of the top post-pandemic clinical trial enrollment challenges sites and sponsors are facing in 2022. Not surprisingly, COVID-19 has completely altered the way we conduct trials and navigate the complex landscape of health and safety of patients and site staff.
The tension from travel restrictions and safety protocols has resulted in trends such as high staff turnovers and limited patient participation, which has led to increased strains on clinical trial enrollment. What is your plan for overcoming these enrollment challenges? How are you going to pivot the way you conduct research to put patients first?
To help, we outlined three enrollment challenges the industry is facing today and how mobile care with 20/20 Onsite’s Mobile Vision Clinics can help alleviate those burdens for your early or late-stage ophthalmic clinical trials or non-ophthalmic clinical trials that require ocular assessments.
Enrollment Challenge 1: Clinical research site staffing shortages
In WCG’s study, the group found “staffing” takes the number one spot for clinical research site challenges, noting a 16-30% turnover rate. When sites shut down and clinical trials came to a halt as the pandemic first began, it created a backlog of studies, which has created additional tension between sponsors and site staff when prioritizing which studies can get done. The delays have created a trickle-down effect that is reaching everyone involved in clinical research — including patients.
How can 20/20 Onsite help increase site staffing?
20/20 Onsite can help ease the enrollment burdens due to site capacity or staffing shortages. By having our Mobile Vision Clinics on-site at your clinical research site, we can act as an extension of your site team — think of us as another exam room that just has wheels!
Our Mobile Vision Clinics can have any combination of pre-screened, licensed, and GCP-certified staff of technicians or other care providers. We also have an experienced patient management team who have helped us earn our consistently above-average patient satisfaction ratings. Having our team there as additional support relieves some of the stress your clinics and centers may face.
Enrollment Challenge 2: Trial complexities that limit patient pool
According to the same research, sites are reporting a 70% increase in Phase III trial procedures over the last decade, along with a 300% increase in data collection points. The more complex the protocol, the greater strain it puts on sites as they have to follow a more comprehensive endpoint collection schedule. That’s not a good match to the first enrollment challenge of staffing shortages, especially when many research sites have been forced to recruit more junior-level employees to help fill empty positions but may not be as experienced with complex protocols.
In addition to contributing to the staffing shortage challenges, increased trial complexities involve more inclusion and exclusion criteria, which can ultimately limit the patient pool as there are more specific requirements for participation. Especially in rare disease studies, qualified patients may be scattered throughout the country and not able to participate in a trial due to distance to a research site. As a result, sponsors and CROs may not be able to make enrollment timelines due to not enough qualified patients enrolling in their trials.
How can 20/20 Onsite help reach a wider and more diverse patient population?
As a site or a vendor on wheels, 20/20 Onsite can essentially go anywhere your patients — or potential patients — are. This means we can reach more diverse communities with individuals who are better matches to your trial requirements and also receive potentially life-altering care they may not have received before.
This benefit also allows us to work directly with community patient groups to understand how to develop less burdensome protocols to improve retention. In fact, in previous trials, our team has proposed protocol changes based on patient feedback, which was ultimately approved, which then greatly improved the patient experience especially for the visually impaired.
Another benefit of 20/20 Onsite is our ability to pre-screen patients before they even arrive at your clinical research site to ensure they are qualified to participate. Pre-screening not only alleviates logistics and processes for more complex protocols, but it reduces strain on site staff as they won’t be faced with ineligible patients and screen failures. Therefore, including 20/20 Onsite in your pre-screen process positively impacts tangible costs and enrollment speed.
Lastly, as a clinical research site on wheels, you may be wondering if the data we collect onboard our Mobile Vision Clinic is as reliable as the data collected in brick-and-mortar settings, especially when it comes to more complex data collection. Our researchers recently completed an observational study to access the quality of subjective refraction, autorefraction, and keratometry measurements which determined there is no statistically significant difference between data collection in the two settings.
Enrollment Challenge: Decreased physician capacity
Lastly, the WCG study found physician capacity as a growing concern. Over the last three years, the number of trial starts has remained relatively consistent, but the number of US investigators is steadily declining. 40% of investigators are involved in only one trial, indicating a dwindling interest and availability for physicians to perform this research. What is your plan to address this gap in investigators and physicians as the number of clinical trials continues to grow post-pandemic?
How can 20/20 Onsite help increase PI capacity?
If your study needs an additional site or Principal Investigator, one of 20/20 Onsite’s doctors can be a PI on your study and utilize our mobile clinic as one of your sites. We schedule with patients, conduct activities on the schedule of assessments, and enter data into the EDC just as your other sites do.
Additionally, our Mobile Vision Clinics allow physicians to increase their patient capacity, especially in traditionally underserved communities where specialists aren’t easily accessible. In fact, our researchers recently discovered 36 New England counties were at high risk for age-related macular degeneration (AMD)but were over 100 miles away from a specialist. Our clinics can bridge the gap between hard-to-find patients and clinical testing.
20/20 Onsite: Your solution for clinical trial enrollment challenges
If your study is at risk for enrollment challenges, let’s discuss how 20/20 Onsite can help you overcome those barriers and meet deadlines. Fill out the form below to immediately download our two-pager to learn how 20/20 Onsite can bring convenience, efficiency, and a top-rated patient experience to your clinical study.