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<h2>Council Concept Clearance – Regenerative Medicine Clinical Trial Planning Grant</h2><p><strong>Program Lead/Presenter: Jimmy Le</strong><br><strong>Council Date: June 11, 2021</strong></p><h3>Goal</h3><p>The NEI is seeking approval to develop a Regenerative Medicine Clinical Trial Planning funding opportunity to support applicants in their planning efforts to conduct a clinical trial to evaluate interventions that restore vision in humans through regeneration of cells in the eye. Regenerative strategies may include the use of adult stem cells, precursors, or stem cell- derived progenitor cells; and may employ methods for converting endogenous cells such as glia into photoreceptors (PRCs) and retinal ganglion cells (RGCs) in the eye.</p><h3>Rationale</h3><p>Currently, the NEI has one R34 Clinical Research Study Planning Grant Program (https://grants.nih.gov/grants/guide/pa-files/PAR-19-231.html) to support the development of a comprehensive research protocol for complex, large-scale clinical vision research projects, including randomized clinical trials and epidemiologic studies. NEI does not currently have a mechanism to facilitate planning of clinical trials to evaluate regenerative strategies. Moreover, it is sometimes necessary to conduct preliminary studies to evaluate the feasibility and collect safety/toxicity data and other pre-clinical data of regenerative strategies as part of the planning process. This initiative can be used to support these preliminary activities but must not be used to conduct an actual clinical trial (i.e., Clinical Trial Not Allowed).</p><h3>Objectives and Scope</h3><p>Projects supported under this funding opportunity would (1) support the preparation of a clinical trial manual of procedures (MOP) to document the trial’s rationale, design, analytic techniques, protocols and procedures; and (2) conduct preliminary studies to refine study procedures, document recruitment potential, and assess feasibility and acceptability of the approaches to be used in a future full-scale clinical trial. Additionally, this initiative would (3) support other essential needs of the project such as obtaining regulatory approvals and preparing to establish agreements with requisite partners such as cell manufacturing and production facilities, assay or cell analysis centers, and data coordinating centers.</p><h2>Council Concept Clearance – Greater than minimal risk single-site clinical trials</h2><p><strong>Program Lead/Presenter: Don Everett</strong><br><strong>Council Date: June 11, 2021</strong></p><h3>Goal</h3><p>The NEI is soliciting Council’s approval for a funding opportunity to support single-site clinical trials where the intervention represents greater than minimal risk to the participant.</p><h3>Rationale</h3><p>Currently, the NEI has programs that support applications proposing mechanistic or minimal risk trials. Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. On the other end of the spectrum, NEI also supports large-scale, greater than minimal risk, multi-center clinical trials, and other complex or high resource clinical trials that are managed by the Collaborative Cooperative Research Program. These clinical trials are multifaceted and typically include the Chair’s Grant (<a href="https://grants.nih.gov/grants/guide/pa-files/PAR-21-041.html">https://grants.nih.gov/grants/guide/pa-files/PAR-21-041.html</a>), a Coordinating Center (<a href="https://grants.nih.gov/grants/guide/pa-files/PAR-21-042.html">https://grants.nih.gov/grants/guide/pa-files/PAR-21-042.html</a>), a Resource Center (<a href="https://grants.nih.gov/grants/guide/pa-files/PAR-21-043.html">https://grants.nih.gov/grants/guide/pa-files/PAR-21-043.html</a>), and involve many enrolling clinical centers. This initiative is to support investigator-initiated single-site clinical trials that are greater than minimal risk, but less complex and resource intensive than currently supported by NEI clinical trial programs.</p><h3>Objectives and Scope</h3><p>Projects supported under this initiative are expected to be single-site clinical trials with interventions that are greater than minimal risk to participants, potentially involving collaboration among several investigators but would not require a separate Data Coordinating Center or Resource Center. Program staff would provide oversight and safety monitoring appropriate to the risk level of clinical trials supported under this initiative.</p>
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