For the foundations track, no. If you are applying to the advanced track, that involves clinical trial simulation and many design iterations, then yes. Your partner biostatistician will need to apply as part of your application (biosketch and personal statement) and would need to come to the residential course with you. In addition, this year we are accepting applications for independent biostatisticians who wish to get additional training in the design of neurological clinical trials. This application is here.
1. Are you accepting applications for 2017? How can I get an application? When will you decide? How many people will be accepted into the course? We will begin accepting applications in January 2017. Click here for the application. While the application asks for your plan for funding to conduct a trial, the CTMC strongly encourages applicants who have not yet been funded to apply. The application deadline is February 28, 2017. We will make decisions in early spring. The clinical trial idea synopsis, funding plan and quality of local mentor will be important aspects of the selection process. No more than 36 trainees will be selected for the 2017 cohort.
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 in August. 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 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.
6. How much of my time will the CTMC require?
Spring/Summer Phase (April 1 to August 1, 2017): 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. Pre-tests and self-assessments will both take about 1 hour each month. A copy of the 2016 syllabus is available here.
Residential course (August 7 to August 11, 2017): the residential course will start with a dinner reception on the evening of August 7. Lectures will begin at 8AM and end at 5:30PM on August 8 - 10. There will be small group activities in the evenings of August 8 and 10; and a networking dinner on August 9. The course will run 8AM - 12:30PM on August 11. A copy of the 2016 residential course agenda is available here.
Summer/Fall Phase (August 22 - November, 2017): 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 2017. 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.
7. Is there an advanced track?
Please see the application for details. Applicants with more advanced clinical trial ideas that may benefit from adaptive designs, clinical trial simulation, or both may have an opportunity to have additional planning activities. Given the complexity of this sort of this sort of design work, you would need to have a collaborating biostatistician from your institution who is interested in working with you.
8. 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.)
Please email NINDS-CTMC-Info@umich.edu if you have any other questions that are not addressed here.
9. Do I need to have a partner biostatistician to apply?