Faculty in the Department of Neurology at the Indiana University School of Medicine are helping to shape the future of neurological research by preparing early-career investigators nationwide to lead innovative clinical trials.
Laurie Gutmann, MD, neurology chair, is the co-principal investigator of the Clinical Trials Methodology Course (CTMC), funded by the National Institute for Neurological Disorders and Stroke, part of the National Institutes of Health. Gutmann serves on the course’s executive committee along with Robin Conwit, MD, professor of neurology and Sophia Wang, MD, associate professor of psychiatry and adjunct associate professor of neurology.
The program is designed to train investigators with limited clinical research experience in the best practices of clinical trial design and execution. Each year, a select group of early-career clinical investigators from various backgrounds in neurosciences are chosen through a competitive application process to participate in the program, which includes three tracks: foundation, advanced and biostatistics.
Applicants enter the course with a clinical trial concept that involves an intervention — drug, device or behavioral intervention — that is delivered to participants with a neurological condition.
“This is a unique opportunity for any faculty with an interventional clinical research idea in the neurosciences to learn essentials of good study design for clinical trials, protocol development, budgeting — all that will clearly guide your grant application,” said Gutmann, who co-leads the course with Mark Quigg, MD, from the University of Virginia.
Over the six-month course, trainees participate in small group mentorship meetings, webinars and a three-day, in-person conference, which was recently hosted by the IU School of Medicine and held in Indianapolis. These sessions provide participants with the tools to deepen their understanding of clinical trials and to hone their proposed project.
“The partnership with biostatisticians and clinical trialists who have experience in neuroscience clinical trials is difficult to find elsewhere,” Gutmann said. “There are many grant writing courses but not very many that focus on the protocol, the nuts and bolts of what will make your clinical trial have the best design and answer your research question.”
Jared Brosch, MD, associate professor of clinical neurology, was part of the 2023 CTMC cohort.
He decided to apply for the program after he was denied external funding through the Alzheimer’s Association Part of the Cloud grant series. His research, in collaboration with the Landreth Lab at Stark Neurosciences Research Institute and headed by Miguel Moutinho, PharmD, PhD, assistant professor of medical and molecular genetics, focused on translating a compound from rats into human.
“There was some feedback given, but the idea of resubmission seemed somewhat daunting at the time. When I heard about CTMC, I thought it would be a good way to refine and re-energize the resubmission,” Brosch said. “Through the brilliant mentors at CTMC, I received very good feedback on the trial design, statistical analysis and resubmitted and was awarded the grant. The clinical trial is currently ongoing!”
Brosch was invited back for this year’s in-person program to share his experiences as a panelist during a session titled “Return of the Jedi.”
“I have a success story in terms of how CTMC helped me turn the corner with funding and grantsmanship, but that is exactly what CTMC is meant to do, and my experience is not unique,” he said. “That said, when you are going through CTMC and perhaps frustrated like I was, fresh off of a ‘failure,’ hearing from an alum who was in your shoes, feeling the same thing you felt can be inspirational — I hope that is what I what I was able to do for others this year.”
Historically, CTMC trainees who have completed the course have a higher likelihood of subsequent extramural funding and lasting careers in clinical research.
A paper co-authored by Gutmann, Conwit and others, and published in Neurology Education, reported that of the 173 foundation track trainees enrolled in CTMC from 2014 to 2023, 62% who submitted a National Institutes of Health grant as principal investigator or co-principal investigator were funded within a median of three years after course completion.
Additionally, of the 243 total enrolled (including the foundation and other tracks), trainees published 7,666 peer-reviewed articles from their enrollment year to 2023.
“You might say this group is biased to be successful,” Gutmann said, “however, we believe the networking with faculty and other trainees helps them move forward and become more effective sooner.”
Brosch encourages his IU School of Medicine colleagues to apply to be a part of next year’s cohort. Applications for the 2027 course open Dec. 1.
“The combined experience of the mentors, the access to lectures that remove some of the mystery behind trial designs and choosing endpoints, and the one-on-one grantsmanship can make the difference in being successfully funded,” he said. “Attendance for me was inspiring. We know the statistics are intimidating, and it is normal not to get funded. I looked at it as a ‘fail,’ but it is just part of the process. That positive take-away was the motivation I needed to move forward.”
