• The Future of Clinical Trials

    Now that clinical trials have become an integral part of the practice of ophthalmology, how can we expect them to evolve? Frederick (Rick) Ferris III, MD, offered a concise overview of where clinical trials are headed—as well as how they’ve developed and matured—when he delivered the Charles L. Schepens, MD, Lecture during Retina Subspecialty Day on Friday.

    Working with big data. Dr. Ferris expects the integration of clinical registries, such as the Academy’s IRIS Registry (Intelligent Research in Sight), with electronic health record (EHR) systems to be useful for the generation of hypotheses.

    He cautioned, however, that considerable logistical work is needed. One practical hurdle involves how data are transmitted. The National Eye Institute (NEI) might serve as a model for the process, Dr. Ferris noted, as “data migrate each night at the NEI to a central database.”

    Additionally, “We need EHRs that can talk to one another or at least to a central site,” he said. “They need common data elements. This will probably happen [first] within controlled networks, as with the NEI.”

    What’s next for the DRCR.net? The DRCR.net, which was established in 2002 and has helped usher in the anti–vascular endothelial growth factor (anti-VEGF) era in diabetic retinopathy (DR) care, will continue with expansion into other eye diseases, Dr. Ferris said. At present, follow-up is ongoing with protocols U (patient with central-involved macular edema who present with good vision), V (patients with persistent central-involved macular edema), and AA (the use of ultra-widefield imaging). Recruitment continues with 3 additional protocols: W (anti-VEGF for prevention of proliferative DR and diabetic macular edema), AB (prompt anti-VEGF or prompt vitrectomy for vitreous hemorrhage from proliferative DR), and Genetics (genes associated with DR). For more information, see http://drcrnet.jaeb.org.—Jean Shaw

    Financial disclosures: Dr. Ferris: Bausch Lomb: P.

    Disclosure key. C = Consultant/Advisor; E = Employee; L = Speakers bureau; O = Equity owner; P = Patents/Royalty; S = Grant support.

    IRIS ® Registry is a trademark of the American Academy of Ophthalmology®.