Age-related macular degeneration (AMD), diabetic macular edema (DME), glaucoma, and uveitis are among the leading causes of ...visual loss worldwide. The societal impact of the loss of vision from these diseases is tremendous. The development and eventual availability of pharmacotherapeutic agents for these diseases have helped to preserve vision and reduce blindness for millions of patients around the globe. However, there are still many unmet needs: the high cost of drugs (often resulted from the financial investment into the development of the drugs), the delay in diagnosis secondary to lack of sensitive diagnostic devices, and the burden of treatments on physicians and patients, have made it impossible for all patients to get the best possible therapy for their ocular diseases.
Developments of ophthalmic pharmacotherapeutic agents and devices consist of different stages before a drug or device is approved by the Food and Drug Agency (FDA). Proceeding to the next stage often requires the success and lack of significant safety concerns from the previous stages. Only a very small number of compounds investigated in phase 1 will eventually make it to phase 2 and 3 for further testing. As such, pharmaceutical and device sponsors are very careful and often reluctant to study pharmacotherapeutic compounds in its infancy due to costs, liability, and risks. Yet, without the early proof-of-concept, pilot studies, many compounds will not have the opportunity to enter clinical testing, making it impossible to show potential benefits for patients. Many clinician scientists are interested in evaluating novel compounds and conducting first-in-human testing. However, the exuberantly high cost of employing the central research organization (CRO) to assist in conducting an early-phase clinical trial with many potentially unknown adverse events and expectations are often the limiting factor in deterring Clinician-scientists from pursuing first-in-human clinical studies..
GORC is established to fulfill the unmet needs to provide coordinating support for single centered and ... multi-centered first-in-human, first-to-assess, novel and original clinical trials to evaluate a pharmacotherapeutic agent or an imaging device for ocular diseases. As a not-for-profit organization, GORC aims to work with Clinician-scientists, clinical research teams, other profit and non-profit organizations in the US and throughout the world facilitate the conduct of trials and studies at the lowest budgets possible while maintaining the highest quality set forth by the FDA and other regulatory bodies.
To achieve its goals, GORC partners with professional colleagues around the globe whose main goals are in line with... those of GORC: that is to provide quality service at minimum cost to enable clinician scientists to investigate very early testing of pharmacotherapeutic agents and devices without being hindered by the limited amount of funding for pilot studies and to assist clinician scientists and pharmaceutical companies design and acquire preliminary seed data to plan for future pivotal studies. GORC will collaborate with clinician scientists and scientific team members who wish to conduct very early trials and studies to provide coordinating activities from initiating and certifying participating sites to obtaining institutional review board (IRB) approval to setting up electronic clinical report forms (eCRF) to collecting and filing adverse events with the FDA and IRBs. In addition, GORC will also help research team members to contact and connect to other potential partners in a clinical study or trial such as appropriate centers of clinical excellence to serve as participating sites for specific disease indications, laboratories to perform serologic testing and analyze ocular fluid samples, and centralized reading centers to acquire and grade ophthalmic images in masked manner to preserve study integrity. Collaborative partners must recognize the financial constraints of early pilot, often investigator-initiated studies and the missions of GORC in helping to enhance scientific knowledge in the field of pharmacotherapy for ophthalmic diseases to benefit patients. GORC will continue to make efforts to expand its connectivity with clinician scientists in the US, Europe, and Asia (and other continents as opportunities arise) and encourage them to focus on developing novel ideas and approaches to evaluating new therapeutic agents and devices while leaving the logistics of executing their clinical trials and studies to GORC. At the desire of the investigators, GORC may also participate in negotiations with potential funding sources to help with funding budgets and contract execution..
It is expected that GORC will be a financially independent organization, self-sustained, and not-for-profit. Operational costs... of GORC will be covered by contracts with investigators who have already obtained their funding to conduct studies or who would like to engage GORC in applications for the funding” process or with pharmaceutical companies, especially start-up companies, which have specific interests in partnering with organizations that wish to investigate studies with non-prohibitable costs. Funding from various studies and trials will be funneled into research and development to generate more effective, more innovative, and more economical approaches to conducting pilot, proof-of-concept, early clinical trials and studies.
Please contact us via email or telephone and a member of GORC will communicate with you.
Global Ophthalmic Research Center
