Yes, the 2025 Clinical Trials Methodology Course is currently open to applications. Please find the application instructions here.

Please refer to the application instructions for the full application requirements. Your application will include a brief description of your proposed research project & its significance, the target funding mechanisms for your trial, and information about your team and mentor.

The last page of the application instructions provides a linked template for you to organize your application materials. Please export the template into a word document, complete each section, and combine all materials into one PDF document. You will submit your application via a REDCap survey form which includes a place to upload your complete application package. 

The CTMC is designed to train early career investigators and biostatisticians to develop scientifically rigorous, yet practical clinical trial protocols related to the clinical neurosciences. The 2025 course will include 2 tracks:

• Foundation track: Investigators who have not previously designed their own prospective, interventional clinical trial. Projects in this track will typically be single-center and early phase.

• Advanced track: Investigators who are proposing a large, multi-center trial. Investigators in the advanced track will typically have prior clinical trials experience as a site PI or co-investigator, although for some rare or pediatric diseases, a multi-center trial may be required for the initial trial.

We are committed to diversity, equity, inclusion & accessibility. Investigators from underrepresented groups in research are strongly encouraged to apply.

We are looking for applicants who are designing a clinical trial that involves an intervention (drug, device, behavioral intervention, etc.) that is delivered to a participant with a neurological condition. Investigators who participate in the course should intend to submit the developed project for funding and carry out the study as the trial leader.

A single arm study looking at the association between a biomarker and a neurological outcome would generally NOT be well suited for our course even if a clinical trial may be the correct next scientific step for the research. However, a single arm trial (futility design) that delivers an intervention would be considered for the course. Trials that incorporate historical controls are eligible as well, if appropriate for the specific disease area. Studies in pediatric populations are encouraged to apply.

Yes, we strongly encourage investigators with clinical trials related to neurological rare diseases to apply. The course follows the NIH definition of a rare disease which is a disease that affects fewer than 200,000 people in the United States.

Residents are not eligible to apply.

Fellows are eligible to apply. This course is designed for applicants who have ownership of their project (principal investigator) and will be able to navigate the project through its initiation and completion. Historically, it has been challenging for fellows to meet this requirement.

Yes, but it must be reviewed and co-signed by the department chair. The letter must also address the feasibility of performing a clinical trial within the timeline of your training.

Absolutely. Please make sure that your department chair at the new institution completes the chair letter for your application. Also, we would prefer that your local mentor be at your new institution to facilitate the conduct of the trial. Please note that if you are starting your first faculty position after fellowship, we have historically found it difficult for trainees to have adequate time to participate in the CTMC due to added responsibilities.

Yes, we welcome applications from non-US citizens or permanent residents. We have had trainees from outside the US before. However, we can only cover the costs of travel within the United States so you would be responsible for getting from your country of origin to the U.S.

• Too ambitious of a study in scale or in translation of science

• Underpowered efficacy studies

• Drug, device, and/or technology to be utilized is not actually available for use in the trial

• Drug, device, and/or technology is unclear if it is practical and safe for humans

• Clinical trials are not allowed in NINDS R21 planning grants. Applicants should consider CTSA and foundation funded research grants to obtain pilot data.

• Please adhere to the page limits. You can make the references hyperlinks to save on space. Applications that go over the page limit typically can improve on focus and clarity.

• Please consider reviewing the following tutorial on Pilot and Feasibility studies - Thabane, Lehana, et al. "A tutorial on pilot studies: the what, why and how." BMC medical research methodology 10.1 (2010): 1.

The CTMC course requires an ongoing time commitment from both the trainee participant and their mentor. Applicants are required to obtain a letter of support from their Department Chair that includes a commitment for protected research time throughout the duration of the course.

Spring/Summer Phase (March - June):You will spend at least 3-5 hours per week working on assignments, reviewing course material, participating in small group meetings, and attending webinars virtually. A copy of the 2023 syllabus is available here.

Residential course (June 23-26 in Charlottesville, VA): The residential course is a 4-day, in-person meeting. Course participants are expected to attend the entirety of the meeting and be free from clinical, teaching, and other professional responsibilities. A copy of the 2024 residential course agenda is available here.

• Monday: Travel day with a welcome session and dinner in the late afternoon and evening.

• Tuesday: Lectures, small group meetings and faculty office hours from 8:00am – 5:00pm. Networking dinner with your small group in the evening.

• Wednesday: Lectures, small group meetings and faculty office hours from 8:00am – 5:00pm. Large group dinner in the evening.

• Thursday: Lectures, small group meetings and faculty office hours from 8:00am – 12:00pm. Attendees will depart for travel in the afternoon.

Summer/Fall Phase (July – September): You will continue to spend 2-3 hours per week working on your project and participating in small group meetings, as well as preparing for and participating in a mock study section.

From a previous trainee:

“[Prior to the course] I spent about 4-6 hours per week in writing grant application and protocol for my project. One of the great advantages of the course is the ability to get expert, independent feedback on the proposed project. I wanted to have strong working application in advance of starting the course so [I] could hit the ground running.

During the course, I spent 4-8 hours per week working on the grant application/protocol submissions including writing, prep work (e.g. surveying patients, meeting with collaborators, discussions with funding agency, etc.). This is work I would have been doing whether I took the [course] or not. I spent an additional 1-2 hours per week with formal seminars.”

Yes, the 2025 cohort will include an advanced track focused on multi-center trials. Investigators in the advanced track should have experience working with clinical trials, often as a site PI or a co-investigator. These projects will be geared towards submission to one of the NINDS funded networks (i.e. SIREN, NeuroNEXT, StrokeNet). 

Certainly! Our course is for people who are designing clinical trials (that are interventions delivered to humans). 

It is targeted towards someone who would be the scientific leader and creator of that clinical trial (i.e. the principal investigator). Having a mentor is expected; their role should be to help you implement YOUR project. You would be the first author on the main publication that was derived from the clinical trial you designed. In addition, we would generally expect that you would be listed as the Principal Investigator on the informed consent document used for the trial.

It would not be helpful for you if the goal is for you to assist the scientific leader of the clinical experiment in the conduct of the trial (i.e. if someone else is telling you what to do and you are in more of a project manager type role.)

No. Early career biostatisticians who are interested in participating in the course should email us at ninds.ctmc@virginia.edu to discuss their eligibility.

If you currently have the grant for this project submitted to NIH as a proposal, the timing of the course may not be a good fit. If you are in some preliminary step (including proposal review at StrokeNet, NeuroNEXT, SIREN), the course may be a good fit - we would recommend you ask your contacts with the relevant CCC and DCC if they think you might benefit from the course. Issues arise when NIH peer review and our course provide you with different suggestions for improving your design, so projects submitted as proposals to NIH and currently under review are not a good fit. If you have submitted once, have summary statements and were not funded the course may be a good way for you to improve your project, assuming the timing for a resubmission is November after the course or later.

An alumni of the course stated, "I feel that the return on investment for this course is high. Independent feedback on [my] grant submission is invaluable to help identify strengths and weaknesses with [the] protocol. I made numerous changes to the methods for the project based on feedback through the [course]. The mock study section was also great." 

No, that is generally not a good fit for the course. However, if you want to work on the design for the follow-up study (knowing that there will be specific parts that will be informed by your ongoing project) then that will be considered and may be a better experience.

No, there is no cost to the course participants. The residential portion of the course requires travel, but travel (within the U.S.) and accommodations are provided by course funds.

We are not aware of other similar project-based courses in clinical trial design. All are welcome to view our webinars that are archived and available on our website.