Mobile optometry service expands clinical trial support

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Thanks in part to the recent completion of an $8m investment, 2020 On-site plans to expand its services, including the mobile support of vision research.

2020 On-site is a Boston-based mobile optometry company that recently wrapped up an $8m USD investment to help fuel its expansion plans. The company’s services include support for clinical studies, via delivery of ophthalmic assessments conducted at or near patients’ residences.

2020 On-site CEO Alexis McLaughlin told Outsourcing-Pharma that because of the COVID-19 pandemic, a significant number of patients (up to 20m adults) delayed their regular eye appointments and put off much-needed cataract surgery and glaucoma treatment; this caused a monumental loss of revenue at clinics nationwide.

During the pandemic, we expanded our services, not just to businesses, but people who are not at work,” McLaughlin told OSP. “We expanded to residential senior living and then into the clinical research segment.

She said the company decided to increase its services to clinical trials because they witnessed how vision-centered research (like trials across the board) hit the pause button because of the pandemic and continue to struggle now that the pandemic is beginning to dwindle.

A lot of sponsors are having a hard time restarting trials, and getting trials started after the pandemic,” McLaughlin said. “Pre-pandemic, 85% of clinical trials failed to recruit and retain enough patients to meet their enrollment timeline.

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Alexix McLaughlin, CEO, 2020 On-site

With 2020 On-site’s mobile model, she said, trial teams are able to take advantage of a unique solution to the all-too-common problems associated with patient recruitment and engagement.

We're really one of a kind, especially in optometric clinical research; we accelerate historically compressed clinical research timelines, and fundamentally improve the patient experience by bringing the assessment and the site directly to the patient, all while adhering to the highest clinical standards,” she remarked.

Other struggles trials face, McLaughlin commented, including recruiting patient populations sufficiently diverse in terms of race, age, geographic location; compounding these challenges with the impact of COVID-19 meant under 45% of trials reported their data by their target date. And, she said, lack of diversity is closely connected with where sites are located.

There was a recent survey in the Journal of Ophthalmology highlighting the issue, where 4% of Black Americans suffered from AMD, but only 0.17% participate in trials,” she pointed out. “We have this unique capability to potentially enable sites that historically wouldn't participate in clinical research—we can go to where the patients are and where those diverse patient populations are.

In May 2020, the company joined forces with Applied Genetic Technologies Corporation (AGTC), an AAV gene therapy firm focusing on inherited retinal disease, to structure trial support services for its studies. Together, the two companies have completed a number of assessments in several states.

We’ve been thrilled to work with 2020 On-site on their ground-breaking approach for patients that are enrolled in our trials,” said AGTC president and CEO Sue Washer. “They have been driving innovation to help patients by expanding access to vision care and to clinical trials; 2020 On-site truly stepped up during a challenging time to improve access and to support our commitment to patients participating in our clinical trials.” 

McLaughlin said the collaboration came about as a result of AGTC’s desire to come up with a contingency plan for continuing its research in the face of COVID-19, and out of dedication to its patients.

They felt a commitment to continue to collect data in a way that patients felt safe,” she told us. “With a rare disease, many of the patients had to fly to the site, because there were only a few sites.”

2020 On-site worked closely with AGTC to understand the protocol, reconfigured its mobile clinic to accommodate the specialized requirements of the research, properly trained its staff to handle the work, obtained certification, then hit the road.

In the last year, we've completed 150 assessments over 24 states, across four trials, and in three indications,” McLaughlin said, adding that Washer indicated AGTC met its goal of reporting data from all three studies in Q4 of 2020.

Going forward, McLaughlin told us, the company plans to add to its fleet and launch an industry and scientific board to delve deeper into challenges like patient enrollment and diversity. And, as the healthcare and research industries continue to recover from the COVID-19 pandemic, it expects continued growth and opportunities.

As companies get back to work, we expect work will be hybrid for about 80% of the people 80% of the time, or something like that, but people will be going into an office,” she remarked. “We expect more sponsors to embrace decentralized trials…the reality of the market is that in order to recruit and retain patients, they're going to have to think more about the experience and how they make it more convenient for patients to participate in care.”