Hybrid clinical trials combine traditional site-based research with decentralized trial (DCT) elements. These can include remote monitoring via apps and wearable technology, as well as virtual consultations.
Understanding Hybrid Trial Models and Their Value in Ophthalmic Research
The goal of hybrid clinical trials is to help reduce patient burden, which can be significant if they’re required to travel to take part. These are more flexible options that can allow for demographics that would not otherwise be able to participate. By making the process easier, the hope is to increase recruitment and retention.
Decentralized clinical trials can also assist with data collection. It can be easier to collect more comprehensive information in real time via apps and wearable devices.
In ophthalmic clinical research, a hybrid model that blends home, hub, and site visits is necessary. Many of the tools and processes used in these trials can be handled at home.
Clinical trial solutions like mobile sites go a long way toward helping provide accurate results while remaining convenient for everyone involved.
Which Ophthalmic Assessments Belong Where?
One of the most valuable ophthalmic endpoints is best-corrected visual acuity (BCVA). It refers to the highest level of sharpness that a person can achieve with contact lenses or the best glasses. It’s measured using charts with symbols or letters of different sizes.
Optical coherence tomography (OCT) is another assessment used in these clinical trials. It’s a non-invasive, high-resolution imaging test that creates detailed cross-sectional pictures of the cornea, retina, and optic nerve.
OCT is an essential tool to diagnose and monitor conditions like macular degeneration, glaucoma, and diabetic retinopathy.
Another assessment is intraocular pressure (IOP), which measures the fluid pressure in your eye. It’s particularly important for diagnosing glaucoma.
Not all of these assessments will be appropriate for a fully virtual clinical trial, which is why hybrid options can be the solution. Researchers must balance patient convenience, data quality, and operational feasibility when beginning their trials. That is where the home/hub/site model can shine.
This decentralized clinical trial model allows participants to handle some assessments at home and others at mobile sites that are convenient for them. They would only need to travel on-site for the most complex assessments.
What Works at Home (Virtual/DCT Components)?
Can some assessments be performed from home? Here’s what you need to know.
Suitable for At-Home Execution
Assessments that can be conducted well from participants’ homes include certain types of remote visual acuity testing. They require validated digital tools and clear, standardized instructions for lighting, distance, and device setup. Participants can complete basic check-ins and use ePRO on a smartphone or tablet to report symptoms and status updates.
There is a need for telehealth follow-ups with this type of model. Participants will also need to provide updates as necessary to ensure they are not encountering problems with the assessments.
Considerations and Limitations
Home environments will differ, which can be problematic for ophthalmic assessments because factors such as lighting affect results. Test distance could also be an issue. Both of these factors need to be addressed during the enrollment process to ensure participants are aware of what’s expected.
There is also the concern of patient adherence. When this varies, maintaining consistent data becomes more difficult. Although there are numerous types of wearable technology, they are not suitable for most ophthalmic trials. That will mean relying more on apps and other modes of recording electronic data.
What Belongs in a Mobile or Onsite “Hub”?
Some assessments may do best in a mobile environment or an on-site hub.
Why Hubs Are Essential in Hybrid Models
The hubs that make up the hybrid clinical trials allow participants to access a mobile testing site, providing a controlled environment for more accurate assessments. There will be certified staff and calibrated equipment to boost data integrity.
The hubs offer the right balance of flexibility and convenience for patients and high-quality data for researchers.
Best-Fit Ophthalmic Assessments for Hubs
BCVA assessments work well in hubs. They can be primary or follow-up assessments. IOP readings can also benefit from this hybrid trial design, as they will be performed on technician-administered devices. Hubs can also support the type of OCT imaging that requires the highest-quality data.
What Should Stay On-site at a Traditional Clinical Site?
Consider these factors when assessing which assessments should remain on-site.
Visits Requiring Investigator Oversight
On-site clinic visits are still necessary for some situations. If there have been adverse events and safety evaluations are needed, they must be conducted on-site. That’s because there’s a need for careful oversight.
FDA certification processes also require on-site verification. Additionally, investigator-led assessments are not feasible in any other way than by having them in one centralized location.
When On-site Is Still the Right Call
If complex imaging assessments or other procedures are needed, they require clinic visits. The same applies to assessments related to device investigational protocols, as device calibration and proper use are essential.
Also, if the study protocols require randomization, the only way to manage it is to have participants on-site.
Benefits of the Hybrid Approach for Ophthalmology
A hybrid approach offers several core benefits.
Participant-Centered Advantages
Decentralized clinical trials offer several advantages for participants. They will not have to travel as far, which increases retention. It also makes it easier for specific patient populations to participate.
You will reduce burdens on participants living in more rural areas and on those in lower-income brackets who may not be able to travel to the site as often.
All clinical studies will benefit from more diverse participants because this variety offers real-world insight that strengthens the results.
Operational and Data Advantages
Patient-centric hybrid clinical trials offer advantages for researchers, too. They protect endpoint consistency and obtain real-time workflow data, which can be invaluable for comprehensive studies. Participants will miss fewer appointments, improving data integrity.
Additionally, hybrid clinical trials can be cost-effective. Using a trial site 24/7 can significantly spike expenses. Data collection costs can be lower, too, since they will rely on online processes rather than maintaining around-the-clock staff.
When you have faster enrollment and can receive data more rapidly, the entire process speeds up. Aside from also saving you money, it can help you complete your trials more efficiently.
Because you get real-time data, you can address problems as they appear, ensuring your trial isn’t compromised. Overall, hybrid clinical trials are better suited for modern clinical research.
How to Design the Split: Home vs. Hub vs. Site
When making your decision, you should consider several factors.
Start With the Endpoints
When planning the timelines and scheduling for hybrid clinical trials, begin by identifying the endpoints and which model can work better for them. Once you have chosen your endpoints, you can map the visit types.
Build Around Operational Feasibility
Use visit matrices to understand which tasks are more compatible with home assessments than hub-required tasks. You’ll need to balance telemedicine options that provide convenience with the need for high-quality data. Endpoint precision cannot be sacrificed for convenience.
Maintain Quality Throughout
Keep thorough documentation of everything. Ensure technicians are certified, and equipment has been calibrated to the accepted standard.
Know when and how to use eConsent and what tools can be best suited for data capture. If you’re using wearable devices, they need to be connected to reliable electronic data capture programs.
How 20/20 Onsite Supports Hybrid Ophthalmic Trials
At 20/20 Onsite, we offer mobile hubs for all types of hybrid clinical trials via our clinical trial solutions. We provide state-of-the-art digital ocular assessments and calibrated equipment to help you deliver BCVA, IOP, OCT, etc, assessments efficiently. Our certified technicians offer ongoing support.
We offer clinical trial rescue services, too. We provide support for recruitment and retention. If missed visits are derailing your results, we can find the solution that works with your trial needs.
Our business model is all about flexibility. We deploy our Mobile Vision Clinic to biopharma companies and contract research organizations for drug development. We can even come directly to research sites. By taking one of our clinical mobile units' virtual tours, you can get a better sense of everything we offer at 20/20 Onsite.
Ready to Design Your Hybrid Ophthalmic Model?
If you’re planning an ophthalmic clinical trial and want to increase recruitment while improving diversity and patient retention, consider hybrid clinical trials. The team at 20/20 Onsite can help you determine which assessments are best suited for the home, hub, or trial site.
It’s very easy to get started. Book a call with our team to get started.
Read our frequently asked questions to get a better sense of what to expect from hybrid clinical trials.