Council Concept Clearance – Reissuance for “NEI Clinical Research Study Planning Grant Program”
Program Lead/Presenter: Jimmy Le, ScD, Collaborative Clinical Research
Council Date: February 11, 2022 (January 2022 Council)
Goal: This concept clearance is for the reissuance of PAR-19-231 NEI Clinical Research Study Planning Grant Program R34 Clinical Trial Not Allowed. The National Eye Institute (NEI) collaborative clinical research planning grant is designed to facilitate activities central to the refinement of clinical research protocols and procedures for vision clinical trials or epidemiologic studies, including the development of a detailed Manual of Procedures (MOP). The planning grant may also support the conduct of preliminary studies to refine study procedures or document recruitment potential (i.e., to demonstrate feasibility). The grant, however, must not be used to generate data on the effects of a proposed intervention, i.e., applicants must not propose any research conducted as part of the planning process that meets the NIH definition of a clinical trial (as defined in NOT-OD-15-015).
Rationale: The NEI supports large-scale clinical vision research projects, including randomized clinical trials and epidemiologic studies on eye/vision conditions. At the time of submission, applications requesting support for these activities are expected to provide detailed information regarding the study rationale, design, analytic techniques, protocols and procedures, facilities and environment, organizational structure, and collaborative arrangements. This information is best conveyed in an MOP, the development of which represents a costly and time-consuming activity. The collaborative clinical research planning grant funding opportunity supports applicants in their planning efforts to conduct collaborative clinical research.
Objectives and Scope: A collaborative clinical research planning grant is designed to
- Permit early peer review of the rationale for the proposed clinical trial or epidemiology study;
- Provide support for the development of a detailed MOP; and
- Support the development of other essential elements of the clinical study, which may include but are not limited to the following:
- Establishing and documenting collaborative arrangements.
- Instituting means to assure standardization of procedures across sites and among staff.
- Developing tools needed for data collection and data management.
- Developing/finalizing data and safety monitoring plans (e.g., identify expertise that will be pertinent in forming the Data and Safety Monitoring Committee (DSMC) or a Monitoring and Oversight Committee (DMOC).
- Developing plans for any training that is required to carry out the proposed study, for example, training of data collectors and individuals who will carry out the planned intervention.
Funding of a planning grant does not guarantee nor imply funding for any subsequent competitive application for the support of a full-scale clinical trial or epidemiologic study.