Clinical Trials Methodology Course in Neurological Disorders

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.