Prospective Observational Comparative Effectiveness Research in Clinical Neurosciences (UG3/UH3 Clinical Trial Not Allowed)

The National Institute of Neurological Disorders and Stroke (NINDS) is encouraging grant applications for their Funding Opportunity Announcement (FOA), titled "Prospective Observational Comparative Effectiveness Research in Clinical Neurosciences". This grant does not allow for clinical trials and is focused on prospective observational comparative effectiveness research (CER).

Research for this grant should align with the mission and research interests of NINDS, which can be found on their website. The research could include evaluation of preventive strategies, diagnostic processes or interventions that could include drugs, biological alternatives, medical devices, or a variety of therapies like surgical, behavioral, and rehabilitation.

The proposals should present a cost-effective manner of data collection that can have considerable impact on current clinical practices. The initial stage of the grant, the UG3 phase, will support the planning for up to two years and is based on meeting specific scientific milestones and feasibility requirements. Successful completion of these may lead to a transition to the UH3 phase, which is an observational study phase extending up to five years.

The UG3 and UH3 phases should be applied for as a single application, following the instructions provided in the FOA. The UG3 phase involves both scientific and operational planning activities, including data collection, storage, analysis feasibility, recruitment and retention strategies, case report forms, data management systems, and other data and quality management tools.

The UH3 phase supports the investigator-initiated observational study. Successful navigation of these two phases will allow for well-planned and impactful research.