Over the last few years, there has been increasing demand for Ophthalmology involvement in clinical trials. Many protocols now require initial and sometimes on-going monitoring for ophthalmic complications. For example, certain antibody-drug conjugates currently in trials at UCM have an almost 100% rate of corneal complications, and require specialized ophthalmic care. At present, many study protocols simply say “eye exam” or something comparably vague and do not adequately detail the required exams and testing. Many times, the sponsor does not even know what ophthalmic tests should be ordered – this results in unnecessary tests being mandated by the protocol, and occasionally, appropriate tests not being part of the study, thus potentially jeopardizing the patient/subject safety.
In support of our clinical research portfolio and to ensure top quality data and human subject protection, the Department of Ophthalmology and Visual Sciences (OVS), has developed a number of mechanisms to help facilitate protocols requiring their services.
- New Protocol Review
- Clinical service determination and Medicare Coverage Analysis (RES v. SOC determination) consultation
- Dedicated Clinical Trial Clinic on Friday mornings
- Transparent Pricing model for services not deemed standard of care
- Mechanism for requesting additional services from OVS
For more information about these services or details for how to work with OVS on your next step, please contact us. We will be happy to act as resources for you as you are evaluating new trials.