CTMC FAQs | SIREN

Please email NINDS-CTMC-Info@umich.edu if you have any other questions that are not addressed here.

1. Are you accepting applications for 2024?

The 2024 Clinical Trials Methodology Course is currently accepting applications. Please see the application page for more instructions.

2. Where is the application form?

Please refer to the application instructions. These are being finalized and will be posted as soon as possible. The last page of the application instructions includes a template for you to organize your application materials into one document. Please copy and paste the template into a word doc (or equivalent) and combine all materials into one document. The application portal in REDCap, which is linked in the application instructions, includes a survey and a place to upload your complete application package.

3. What sort of clinical research projects are eligible?

We are looking for applicants who wish to design trials that involve an intervention (drug, device, behavioral intervention, etc.) that is delivered to a patient with a neurological condition. Therefore, a single arm study looking at the association between a biomarker and a neurological outcome would generally NOT be well suited for our course. It may be the correct next scientific step for the problem, but our course is set up for the design of trials that deliver interventions. This might still be a single arm trial (futility design). If appropriate for the specific disease area, trial ideas that incorporate historical controls are eligible.

4. Can residents and fellows apply?

The short answer is yes. The longer answer is that this course is designed for applicants who have ownership of their project and will be able to proceed to seeing the project through its initiation and completion. Residents and fellows are typically not in this category.

5. I am moving to a new institution between now and the in-person course. Can I apply?

Absolutely. Please make sure that your chair at the new institution completes the chair letter for your application. Also we would want the local mentor to ideally be where you are landing in order to facilitate the conduct of the trial. That being said, if you are starting your first faculty position after fellowship, we have found that you may have added responsibilities which make it difficult to have adequate time to participate in the CTMC.

6. I am not a US Citizen or permanent resident - can I apply?

Yes, you can apply and we have had trainees from outside the US before. However for travel, we can only cover it within the United States. So you would be responsible for getting from your country of origin to the US. Within the US we could cover cost of travel to the residential course.

7. I am a resident or fellow. Can my fellowship or residency director write my letter?

Yes, but it should be reviewed and co-signed by the department chair. They will also need to address how doing a clinical trial is feasible within the remaining time horizon of your training.

8. Application Common Pitfalls

Too ambitious of a study in scale or translation of science (we will have an advanced track in the 2024 cohort which will support larger scale studies)
Underpowered efficacy studies
Need to ensure availability of drug and/or technology to be utilized, and make certain it is practical and safe for humans
No clinical trials are allowed in NINDS R21 planning grants. Should also consider CTSA and foundation funded resesarch grants to obtain pilot data
Please adhere to the page limits. You can make the references hyperlinks to save on space like this. 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.

9. How much of my time will the CTMC require?

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

Residential course (June in Charlottesville, VA): The residential course will start with a dinner reception on the first evening. Lectures will begin at 8AM and end at 5:30PM on the other days. There will be small group activities; and a networking dinner during one evening of the course. A copy of the 2023 residential course agenda is available here.

Please note we are not having a fall phase of the 2024 course. All course activities will be completed by June 30, 2024.

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.

10. Is there an advanced track?

Yes, the 2024 cohort will include an advanced track focused on multi-center trials, geared toward one of the NINDS funded networks (i.e. SIREN, NeuroNEXT, StrokeNET, EPPIC-NET).

11. I am not a physician. Can I apply?

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.)

12. Do I need to have a partner biostatistician to apply?

No. There is a separate track for biostatisticians who wish to get additional training in the design of neurological clinical trials.

13. I have a proposal that is submitted and under review at the NIH. Can I apply?

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 (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.

14. What is the return on your investment from the course?

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."

15. Can I apply for the course if my project is already funded?

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.

16. Does participating in the course cost me anything?

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

17. Are there any similar courses offered by NINDS for residents/fellowswho may have less flexibility to attend scheduled meetings?

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.