As clinical trials shift toward a more decentralized model, telemedicine is ready to play a more substantial role. In decentralized clinical trials (DCTs), investigators reduce dependence on intermediary specialists and traditional facilities for data acquisition by using virtual elements to facilitate treatment and data collection in a subject’s home.
Telemedicine is one of many means by which MILO DCTs can engage, and it uses technology to bridge distance between healthcare participants. Research says that in 2021, 29% of ophthalmology trials were fully decentralized or remote, with ophthalmology having the greatest percentage of full MILO DCTs among all therapeutic areas. Also, a survey in 2023, of staff working at clinical trial sites encompassing all therapeutic areas found that 92.7% of respondents expect to facilitate full or partial DCTs in the next 12 months, which is an increase from 87.3% in 2022.
This pattern is likely a by-product of the COVID-19 pandemic that caused unprecedented change and digitalization which has ushered in a new era in how we do life. Likewise, we are changing the dynamic of doing clinical trials.
Inclusion of historically disadvantaged and underrepresented Patients in clinical trials
In addition to being preferred by many participants, MILO DCT also may enhance the accuracy of some studies by reducing selection bias through the inclusion of historically disadvantaged and underrepresented individuals, such as those in rural areas, with low vision, or without reliable transportation.
Including Patient in clinical trials with rare diseases
Further, it can create opportunities for the inclusion of individuals with rare diseases. Findings from a recent survey of participants in oncology trials show that the opportunity to enroll in a DCT modality may result in greater willingness to consent. If the FDA’s recent draft guidance for DCTs is implemented, it is possible that any ophthalmology practice that is close to ophthalmology clinical trial participants could facilitate trial- related activities and visits, even though the ophthalmology staff and providers may not formally be part of the trial personnel.
Also, evaluating participants with primary Sjögren syndrome, researchers found that validated surveys such as the Vision Related Quality of Life and Health Related Quality of Life questionnaires are likely an effective adjunct to in-person consultations. These studies support the notion that investigators can remotely employ surveys in clinical trials where patient-reported outcomes are of interest.
Remote visual acuity test in clinial trial
Additionally, studies found that at-home computer visual acuity testing is comparable to in-office testing and determined that a smartphone app is comparable to an in-office Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity test. Other studies determined that smart TV-based acuity testing is comparable (not inferior) to conventional ETDRS testing.
In studies with children aged 4 to 10 years, surveys found that medical web application distance visual acuity testing is comparable to clinical testing. Ultimately, Researchers tested near visual acuity on Android and iPhone users and discovered that the results corresponded well with acuity taken with the Rosenbaum near visual acuity card. These studies’ results support the comprehension that, once validated in the home setting, remote visual acuity measurement may be able to carry over into many clinical trials where visual acuity is an outcome measure, such as studies involving clinically significant macular edema, age-related macular degeneration, amblyopia, and medical devices such as IOLs and intravitreal implants.
Although one might be concerned with the validity of more complex data collected through DCTs, results of a recent study suggest that ophthalmology nursing staff can accurately gather data on IOP, auto-refraction, keratometry, and visual acuity. This suggests that an ophthalmologist does not necessarily need to be there physically with the subject and that they could review test results remotely. This also specifically implies that investigators can employ telemedicine to accurately capture postoperative refractive data for refractive surgery and IOL trials.
How does it all affect patients with Glaucoma in clinical trial?
Glaucoma trials may also benefit from telemedicine. Patient-administered tonometry measurements have consistently been similar to Goldmann Applanation Tonometer measurements, suggesting that patient-administered IOP measurements may be a potential option for assessing ocular hypotensive and surgical intervention efficacies. In addition, investigators previously demonstrated that remote optic disc imaging effectively identifies patients with optic disc cupping, which could prove helpful in assessing cup-to-disc ratios in patients with glaucoma who are enrolled in clinical trials.
If home-based OCT is on the forefront, it is only a matter of time before retinal nerve fiber layer and ganglion cell layer thickness can be remotely assessed through artificial intelligence and established algorithms, reducing, this way, the need for participants to travel to a data collection site. Remotely measured visual fields, alternatively, demonstrated a positive correlation to visual field testing on the Humphrey perimeter, showing that decentralized visual field testing can potentially monitor visual fields in glaucoma trials.
Final observations on the topic
Additional work is needed before DCTs will be fully accepted by the community, they have the potential to lower costs, improve participant experience, reduce the number of participants lost to follow-up, enhance diversity, save time, and improve clinical trial results. These undeniable benefits are impossible to ignore, and when paired with the validation of remote ophthalmologic testing, investigators will likely accept this innovative approach to clinical trials. However, we cannot expect this transition to occur overnight.
The ophthalmology community will need to settle on which procedures are the most accurate and meaningful and then validate them. Ultimately, the FDA will also need to analyze and incorporate comment submissions regarding their recent draft DCT guidance into unequivocal guidance that investigators can follow. Once these events occur, we can expect a new era in ophthalmology clinical trials.
