AGS Research Consortium (ARC) - Challenge Grant
NATURE OF RESEARCH OPPORTUNITY
Limited funding sources exist to support clinical trial research in glaucoma. The American Glaucoma Society (AGS) Strategic Plan identified creation of a coordinated research network as a major strategic goal. The purpose of this funding opportunity is to provide support for investigative groups (“Study Investigators”) to perform a randomized clinical trial (RCT) in glaucoma that would positively impact glaucoma patient care.
The AGS Research Consortium (ARC) is a two-year, AGS-wide program designed to optimize glaucoma care. This initiative (1) provides a funding source to support AGS sponsored clinical trial research, (2) encourage collaboration among the membership, and (3) develop the infrastructure for shared database amongst AGS members for future studies.
To ensure that the maximal scientific benefit is derived from this significant AGS investment, this funding opportunity aims to support rapid and widespread sharing of de-identified clinical trial data provided by the Study Investigators according to an approved data-sharing plan assessable to interested AGS members, after successful application to a data access committee, established by the ARC.
Previously RCTs in glaucoma have established that lowering IOP slows glaucomatous disease progression. Recent research in the field of genetic epidemiology is shedding new insights into the pathophysiology of open-angle and angle-closure glaucoma.There are presently 5 classes of pharmacological modalities available to treat glaucoma.In addition to laser trabeculoplasty for open-angle glaucoma, and iridotomy and iridoplasty for angle-closure glaucoma, there are numerous new surgical options for treating glaucoma. A major challenge effecting industry support for glaucoma is the development of appropriately designed studies to achieve visually significant endpoints in a time frame that does not economically encumber the research project. Projects that are designed to overcome such an obstacle will be given special consideration in this RFA.
It seems that there are opportunities to determine which combinations of therapeutic options are available to treat specific subsets of glaucoma patients and that networks of clinical researchers working together can discover those opportunities. There are model examples of non-NIH funded trials that have greatly impacted the field of glaucoma including the Collaborative Normal-Tension Glaucoma Study, the Tube vs. Trabeculectomy Study, the Ahmed vs Baerveldt Comparison Study, and the Low-pressure Glaucoma Treatment Study. NIH has invested considerable resources to determine that lowering IOP reduces disease progression in open-angle glaucoma but much more work is needed to optimize treatment for patients with specific glaucoma subtypes.
Knowledge regarding the role of blood flow, intracranial pressure and genetic biomarkers play in glaucoma pathoetiology is emerging. Furthermore, new drugs and alternative surgical approaches will continue to arise. Finally better ways to assess visual fields and the high throughput structural data embedded in computerized optic nerve images are beginning to be realized.
SCIENTIFIC OBJECTIVES TO BE ACHIEVED
The identification of best treatment strategies for selected glaucoma patients based on current knowledge and available resources.
Objectives of this Research Program:
1) This RFA will support Study Investigators to identify robust clinical outcomes that will result in better vision and quality of life for glaucoma patients.Studies will be largely RCTs with either a placebo control or observational arm. Investigators are expected to reach across institutional borders to achieve their research objectives, allowing for more generalizability of their results. Investigators are expected to have access to the study populations that will allow them to achieve their study objectives. Indirect costs will not be supported by this application. Direct costs should be focused mostly on supporting centralized study coordinators and/or biostatisticians, and limited support for a postdoctoral fellow at each site.
A successful application should clearly define the intervention along with its rationale and the outcome to be achieved. The strength of the evidence supporting the intervention and potential impact the intervention will have on the field needs to be delineated. A detailed power calculation supporting the proposed sample size and how achieving the outcome of interest could be completed in 2 years is required.Investigators must indicate that they will share their research findings on a secure AGS website for future use and indicate the potential value of such data to the AGS community at large. The application will contain an excel file with data dictionary, indicating the data that will be shared. Appropriation of funds for approved projects will require proof of IRB approval from all participating institutions.
2) Development of a secure AGS web portal to support a shared centralized database for future ARC supported grants. De-identified data must be posted on this website at the completion of the study in 2 years, regardless of whether it is published.AGS members will have access to this data but there will be a 1-year moratorium of using the data giving the investigators the opportunity to publish their results. After 1 year, as long as other AGS members present an IRB approved protocol to use the data for research purposes only, they can download the data for purposes such as re-analysis of the study results, meta-analyzing the results with pre-existing data or secondarily using the data for other bonafide research purposes. Any breach of data integrity caused by AGS members will not be tolerated and will result in their expulsion from the Society. If it is discovered that this data is published outside the guidelines set forth by the ARC, then the editor of the appropriate journal will be notified and all appropriate actions to disclose such un-sanctioned data use will be pursued.
SUMMARY OF ATTRIBUTES ASSOCIATED WITH COMPETITIVE APPLICATIONS
- Multisite RCT with strong investigative team.
- The project proposed is feasible and can be completed in 2 years.
- The project leverages the latest scientific information about glaucoma in a way to optimize care for our glaucoma patients.
- Principal Investigators must be either AGS Active or Provisional members.
- Investigators from private practice are eligible to apply.
- No external funding source. Internal institutional support is encouraged and is acceptable.
- Investigators agree to share de-identified data and have a robust plan that maximizes the usefulness of the shared data to the AGS community.
Deadline to submit an application is Monday, January 23, 2017