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?
- 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.
[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.
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.