Four Keys to Successfully Supporting Ophthalmology Clinical Trials
Preparing for an upcoming ophthalmology clinical trial? Explore four critical pieces of advice from our expert team.
January 13, 2023
1. Putting Yourself into the Patient’s Shoes
As you plan your ophthalmology clinical trial, it’s essential to place yourself into your patients’ shoes and consider their journey and potential challenges.
- Where will patients affected by the indication you’re studying likely go for treatment?
- Will they be seeing an ophthalmologist, or will it be more likely that their ophthalmologic condition will be handled by their primary care providers (PCP)?
A 2019 article in the Osteopathic Family Physician noted that 2-3% of primary care office visits are eye-related complaints. Conditions commonly seen by PCPs include conjunctivitis, strabismus, uveitis, entropion, ectropion, pterygium, stye, and chalazion. (Kaur et al., 2019)
If your ophthalmology study includes pediatric populations, the consent process must be especially clear, with procedures in place for any possible situations that may arise. For example, what happens if the patient’s parents separate or divorce during the study? What happens if guardianship changes?
2. The Importance of an Excellent Medical Monitor
Medical monitors are always essential assets to a study team, as they have an intimate knowledge of study protocol and robust clinical and academic experience as physicians. A specialized medical monitor with experience in ophthalmology is especially important for these clinical trials.
3. Qualifying Site Staff
It’s important to look closely at the qualification of treatment administrators and staff members. For example, if retina injections are required for your ophthalmology study, a qualification process may need to be created to distinguish between qualified staff (whether they are retina specialists or non-retina specialists) and unqualified staff who may not perform injections in the study. Similarly, if your study includes imaging, it’s critical to qualify each site’s technicians to confirm that images are comparable.
4. Limitations During Site Selection
Unlike many clinical trials in non-ophthalmology indications, equipment for ophthalmology is typically not supplied due to cost limitations. This adds an additional layer of assessment as sites are evaluated.
During the feasibility process, exam rooms must be qualified to see what equipment is available at each site. Sponsors may opt to work with large vendors to encompass the standard equipment used across all sites.
REFERENCES
Kaur, S., Larsen, H., & Nattis, A. (2019). Primary Care Approach to Eye Conditions. Osteopathic Family Physician, 11(2), 28–34. Retrieved May 6, 2022, from 2019.