Why the Model Matters (Virtual vs. Hybrid With Onsite/Mobile Hubs)
Traditional clinical trials often face challenges recruiting participants from diverse backgrounds because there can be barriers that prevent minority communities from taking time off work to participate. Even getting to the location could be a challenge. Remote clinical trials and hybrid options offer the chance to improve patient recruitment.
Virtual clinical trials are a form of decentralized research that allows participants to complete assessments, visits, and follow-ups remotely, thereby reducing or eliminating the need to travel to a traditional investigational site.
Data collection occurs via mobile health apps, wearable devices, patient diaries, and other electronic patient-reported outcomes, all of which are subject to source data verification.
It’s possible to conduct virtual clinical trials fully remotely or as part of a hybrid model. Fully remote clinical research doesn’t require patients to visit the clinic or research location at all. In contrast, hybrid options can require some in-person visits to the clinical trial sites, combined with virtual elements. There are also mobile hub options that allow the trial site to travel closer to patients.
Why does this matter? Different trial designs can significantly influence the diversity of patients enrolled in the trial.
For example, African Americans make up only 15% of minority participants in clinical trials, while Hispanics make up only 7.6%. The FDA has identified this as a serious challenge to drug development and other medical advancements. To improve the diversity of patient populations, the FDA is encouraging innovative and patient-centric trial strategies.
Virtual and hybrid clinical trials tend to be more efficient than traditional options, and the data gathered can go through even more rigorous checks. Real-time data collection, for example, allows for clearer results that don’t depend on scheduled appointments.
For sponsors focused on ophthalmic endpoints, are virtual trials feasible? When it comes to best-corrected visual acuity (BCVA), optical coherence tomography (OCT), and intraocular pressure testing (IOP), several factors should be kept in mind.
Endpoint Feasibility: Home vs. Onsite/Mobile Hub
BCVA (Best-Corrected Visual Acuity)
Best-corrected visual acuity can be measured as part of virtual clinical trials. It will require validated digital tools that deliver real-time results and meet all regulatory requirements. The instructions will need to be standardized and available in multiple languages.
It’s necessary to have telemedicine oversight and to ensure data is collected in appropriate locations. BCVA results are affected by lighting and testing distance. Data capture needs to be detailed.
As you can see, there is a lot that could go wrong, so BCVA benefits from site visits or mobile vision clinics. The hybrid options offer a controlled environment along with calibrated equipment. Hybrid trial models will also involve certified technicians, who can verify data before submitting it. For primary endpoints, a hybrid trial design is often the most appropriate choice.
OCT (Optical Coherence Tomography)
For OCT, a virtual trial simply won’t work. The OCT equipment requires specialized training and calibration because of its complexity. There are high-resolution data requirements, including capturing images and sending large amounts of information in real-time. It’s not feasible for most smartphones and other devices.
It can be difficult for a patient to position themselves correctly at home, leading to skewed results. There is also a lack of established virtual protocols for OTC in virtual clinical trials.
Hybrid options offer the best of both worlds. They allow patients to participate in the trials without facing some of the burdens of traditional studies, while still providing reliable data. Having technicians on-site means accurate grading and consistent images.
IOP (Intraocular Pressure)
Fully remote, decentralized clinical trials can support IOP assessment, but only for select patients. It requires training on equipment such as rebound tonometers and with patients who have stable conditions, such as glaucoma. This data could offer more information for interventions and drug development.
Mobile or on-site trials offer consistency and regulatory confidence. A controlled environment is necessary, and that can more readily occur in a controlled environment like a Mobile Vision Clinic.
Data Quality, Consistency, and Risk Management
For clinical trial participants to provide the necessary data, quality is a focus. In on-site or mobile hub options, it’s necessary to have certified technicians to ensure no questions arise about how the information was gathered.
There must also be standardized environments. Lighting, distance, and equipment calibration allow for viable data that can lead to advancements. All of this is needed to reduce variability. Most fully virtual clinical trials can’t provide this type of consistency.
Virtual trials, however, can provide real-time data that offers more information than traditional trials. Advanced digital health technology, like wearables, offers ongoing metrics. Documentation must be consistent as well. Calibration logs and training records must be thorough and traceable to support endpoints.
One significant concern is security and regulatory compliance. The FDA was among the first entities to issue recommendations for decentralized clinical trials.
Data privacy is one of the most complex areas. There should be a focus on data minimization and pseudonymization, both of which can prevent patient information from being easily identified.
It’s also necessary to have regular security audits and provide patients with education on how their data will be used. Patients need to offer informed consent, which requires educating them on exactly what the trial will involve.
Electronic health records are a vital component of all clinical trials. Integration must be done safely and without putting patient data at risk.
Benefits and Challenges by Model
Virtual
With virtual options, you can access a more diverse patient population. There are fewer financial burdens for patients because they don’t need to travel to participate. This helps with patient engagement and retention.
Enrollment can be faster, enabling the clinical trial to begin sooner. Additionally, it can be a more cost-effective option for sponsors.
The challenges of virtual clinical trials include the variability of each patient’s environment, which can affect data quality. It can be more challenging to make sure patients meet exam windows and maintain data integrity.
Hybrid/Mobile Vision Clinic Hubs
Hybrid options like mobile vision clinics or hubs are patient-centric because they make it easier to receive assessments. Patients don’t have to travel to a single facility; they can go to a local mobile hub, or the clinic can go directly to the patient's house. These models gather consistent, reliable trial data because technicians are involved.
Additionally, hybrid solutions can use advanced equipment to collect better data and help provide in-person patient education. By offering more direct patient interaction, they can ensure scheduling timelines are met, as opposed to relying on patients to do self-examinations.
Trial Design Guidance for Ophthalmic Endpoints
Visit Mapping
When focusing on ophthalmic endpoints in clinical trials, use an endpoint-by-visit matrix to determine when virtual sessions are appropriate and when they’re not. For primary endpoints, the setting should be as controlled as possible, so opt for in-person visits.
Device & Personnel Standards
You will need to specify the exact performance specs needed from devices and equipment, along with how often they need to be recalibrated. Document the training that technicians must have.
Remote Monitoring & Safety
Remote monitoring triggers must be clear. You can choose risk-based, data-driven, or event-driven. If there are adverse events or serious adverse events, there must be a clear pathway for reporting them. Identify when it’s necessary to escalate to an on-site or mobile hub visit.
Patient Engagement & Ops
You’ll need to plan when and how patients receive reminders of interventions and education. Offer real-time troubleshooting as well to ensure the highest-quality data.
Regulatory and Quality Signals to Watch
Regulatory agencies evaluate research gathered from virtual or hybrid trials in specific ways. They look for the validation of digital tools. This means ensuring that all digital tools function as intended and meet the required standards. Good Manufacturing Practices may apply.
Having a clear trial protocol protects all participants and provides guidance, no matter what circumstances arise. It’s also necessary to define endpoints as narrowly as possible and what success will look like for the particular trial. Additionally, if there are data outliers, agencies will look at how you handle them.
How 20/20 Onsite Enables Hybrid Ophthalmic Trials
At 20/20 Onsite, we offer Mobile Vision Clinics and other point-of-need solutions for clinical trials. Our certified staff and state-of-the-art equipment can deliver BCVA, OCT, and IOP (and much more) in a manner that is convenient for patients and sponsors.
To boost patient retention and increase endpoint reliability, we offer patient-day coordination. This is part of our patient-centric approach. For sponsors, we offer site-readiness workflows and startup checklists.
Our team serves sponsors and clinical trial sites nationwide. We offer insight into common concerns and can accommodate diverse patient demographics to help you obtain the research results you need. If your trial is struggling, we have clinical trial rescue services and solutions you can rely on.
Ready to Plan a Patient-Centric, Data-Reliable Approach?
Decentralized clinical trial models can significantly strengthen trial execution, and hybrid options that use mobile vision hubs give patients added convenience without compromising ophthalmic data quality.
While some BCVA assessments can be collected at home with appropriate tools, most interventions and confirmatory testing still require a controlled environment like a mobile clinic.
If you’re planning your next trial or finalizing endpoints, we’d be happy to arrange a virtual tour of our Mobile Vision Clinic to explore how it can support your study.
Schedule a consultation with our team at 20/20 Onsite.