1. Are you accepting applications for 2020?
No. Due to the global COVID-19 (Coronavirus) pandemic and the number of uncertainties that accompany this health crisis, the Clinical Trials Methodology Course (CTMC) Executive Committee decided to postpone the Course until 2021.
2. 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.
3. Can residents and fellows apply?
The short answer is yes, but, the longer answer is we really want to focus on clinical trial projects that can actually be conducted, and given the lead time for IRB applications, funding, it is often unlikely within the remaining time horizon of a resident or fellow.
4. 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.
5. 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 Michigan or Iowa.
6. 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.
7. Application Common Pitfalls
- Too ambitious of a study in scale or translation of science
- 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 Advocacy 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.
8. How much of my time will the CTMC require?
Spring/Summer Phase (April - August): you will spend at least 2-3 hours per week working on assignments, reviewing course material, participating in small group meetings by teleconference, and attending webinars remotely. A copy of the 2019 syllabus is available here
Residential course (July in Ann Arbor, MI) or Iowa City, IA): 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 2019 residential course agenda is available here
Summer/Fall Phase (August - November): you will spend a significant amount of time refining your trial protocol and grant proposal, and preparing for the Mock Study Section which will be held in November. Again, you will need to spend at least 2-3 hours per week working on assignments, reviewing course material, participating in small group meetings by teleconference, and attending webinars remotely. Pre-tests and self-assessments will both take about 1 hour each month. The intention is that this time after the residential course will be similar to what you would already be doing in preparing a trial protocol/grant proposal, but will be enhanced by the mentorship and structure of this course.
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.
9. Is there an advanced track?
No, the advanced track is not being offered currently, although it may resume in the future*.
*NOTE: If you are interested in the Advanced Track for the future please complete this short questionnaire
so that we have your information.
Background on the advanced track: In previous years applicants with more advanced clinical trial ideas that may have benefited from adaptive designs, clinical trial simulation, or both were given the opportunity to apply for an advanced track that provided additional planning activities. Given the complexity of this sort of design work with clinical trial simulation and many design iterations, a collaborating biostatistician from the same institution was requred to work with the clinician.
10. 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.)
11. Do I need to have a partner biostatistician to apply?
No. There is a separate foundations track for biostatisticians (Pathway B) who wish to get additional training in the design of neurological clinical trials.
NOTE: In previous years the advanced track (not being offered currently, although it may resume in the future) involved clinical trial simulation and many design iterations which would require a collaborating biostatistician. The partner biostatistician applied as part of the clinician application (biosketch and personal statement) and was required to attend the residential course.
12. 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.
13. 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."
14. 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.
15. 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.
16. 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.