# Clinical Trials Methodology Course in Neurological Disorders

> **NIH NIH R25** · UNIVERSITY OF VIRGINIA · 2024 · $272,000

## Abstract

PROJECT SUMMARY
 Neurological diseases comprise an extraordinary burden on patients, caregivers, and the healthcare
system; the cumulative direct costs are $993 billion/year. Progress in treatment of neurological diseases
requires clinical research, but research may be limited by a lack of supply of capable physician-scientists.
 The previous generations of the Clinical Trial Methodology Course (CTMC) were effective in training early
investigators. Cumulatively, 62% of CTMC graduates submitted a National Institutes of Health (NIH) grant
proposal, of which 62% were funded. Many others found success in funding from foundations, other federal
agencies, and local sources.
 We propose a training program with the goal of supplying the healthcare system with effective clinical
researchers and clinical biostatisticians who can implement well-designed clinical trials and biomarker studies
in neuroscience. The innovations of the current proposal are to provide a new focus in developing workable,
“fundable” grants that can directly and efficiently supply established NIH research networks (Advanced Track)
while continuing our established, valuable work with early-stage investigators (Foundation Track), as well as
developing clinical biostatisticians (Biostatistics Track). New endeavors in study design will include practices to
increase diversity, equity, inclusion, accessibility, and community engagement. Our proposal draws upon the
deep, institutional knowledge of previous CTMCs and provides new leadership, new ideas, and new metrics.
 Specific aims are to identify motivated, diverse, and less experienced investigators and provide them with
the guidance and tools from a team of peer mentors, clinical faculty mentors, and biostatisticians to develop
proposals, based in best practices, that can efficiently translate to competitive research applications and, in the
Advanced Track, coordinate with networks to prepare proposals that are “submission-ready.” We will further
forge efficiencies and strengths of infrastructure, education, and expertise among the CTMC and research
networks. Finally, we will support career development of diverse, prepared clinical research investigators by
providing them with means to further their careers in neurological investigations.
 In summary, the development of well-trained, clinical researchers will foster better trials design and hasten
the development of new therapies. We will track participant progress (both past and future) to aid in program
adjustments and assess overall program performance. The CTMC in its new iteration will build upon proven
successes while bringing new and specific focus on neuroscience translational and clinical research. We bring
rigor, new energy, and new highlights to a valuable program in the mentoring of tomorrow’s academic leaders,
with a focus on diversity, equity, inclusion, and accessibility for recruitment of faculty and participants.

## Key facts

- **NIH application ID:** 10954541
- **Project number:** 1R25NS138633-01
- **Recipient organization:** UNIVERSITY OF VIRGINIA
- **Principal Investigator:** Laurie Gutmann
- **Activity code:** R25 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $272,000
- **Award type:** 1
- **Project period:** 2024-08-20 → 2029-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10954541

## Citation

> US National Institutes of Health, RePORTER application 10954541, Clinical Trials Methodology Course in Neurological Disorders (1R25NS138633-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10954541. Licensed CC0.

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