Below are the links to all the sessions (1-10) listed in the syllabus.
NOTE: The full PDF version of the 2019 syllabus can be downloaded here.
- Please leave time to discuss which weeks you will be holding sessions. If both faculty are unavailable for a given week it should likely be cancelled. This potentially can be covered by email prior to the first session. You can contact Lisa Garnes (firstname.lastname@example.org) to take any dates you won’t be using off your calendars.
- Complete your project information form (potentially you already did this as part of your application) https://umich.box.com/s/w0vvu871oqyd60t6pkrndkr0capbrzph
- As soon as possible and no later than 48 hours PRIOR to the first session, upload a draft specific aims page AND the project information form into your Box folder for the faculty to review. As noted above, please try to use a word processing document so comments can most easily be left in it. Your faculty probably can leave comments on a pdf as well if absolutely necessary.
- Prepare a five-minute introduction presentation about your clinical trial and why it is important. Please include discussion regarding scientific premise and rigor of prior research/preclinical data. Each trainee will present (with 5 minutes of feedback from faculty) during the first session. Do NOT use slides. You should talk into your webcam. Note again, you should use the project information form as a guideline for the high yield topics you should cover during the presentation (e.g. disease, phenotype, preclinical justification).
- Review Chapter 7 “Selecting Outcome Measures” in Ravina (course text). https://umich.box.com/s/clhd0b3viwenrah7e6zu8084yk9k341v Someone reading your specific aims page should be able to understand your main outcome measure.
- Turn in revised specific aims page in 48 hours PRIOR to session 2 by uploading the assignment in Box.
- Core faculty will provide feedback on submitted outcome measures (within specific aims page or as a supplement with additional information on the outcome measurements) during session 2 (10 minutes each)
Session 3: Overall Trial Concept (design overview / selection / structure / initial feasibility - ballpark sample size / schedule of assessments)
- Review Chapters 2 and 4 in Ravina (course text): https://umich.box.com/s/clhd0b3viwenrah7e6zu8084yk9k341v
- Obtaining intervention (drug acquisition)
- Prepare a 1-3-page significance section for a grant (involving your clinical trial idea). This should include references. The goal is to let the reader understand why your disease is significant and your proposed treatment would represent a significant step forward.
- Upload document to Box at least 48 hours PRIOR to session 3
- Core faculty will provide feedback on concept document during session 3 (10 minutes each)
- Biostatistics trainees (if applicable) should upload a list of questions about each study concept to the Box folder of each clinical trial.
- Review Chapter 27 in Ravina (course text): https://umich.box.com/s/clhd0b3viwenrah7e6zu8084yk9k341v
- Start building the relevant parts of your trial protocol. Download the NIH trial template here: https://umich.box.com/s/148e10106ep0i5xafrail32h6m0ko9lf
- For the first protocol session please complete sections 1 (overview), 2, (introduction – which should be derived from significance section) and 3(objectives and endpoints) please upload to Box so core faculty can review 48 hours prior to session.
- Revise sections 1-3 of protocol based on feedback from first session.
- Draft protocol sections 4 (study design), 5 (study population), and 6 (study intervention).
- Biostatistics trainees (if applicable for small group) should review JAMA article on Statistical Analysis Plans https://jamanetwork.com/journals/jama/fullarticle/2666509 and template https://umich.box.com/s/arycglcyspyfeh31bvfxtzqn66e8lqeo.
- Biostatistics trainees (if applicable for the group) should upload a draft SAP for each project. This can be a fairly high level outline. Ideally, it can be produced from material presented already by the clinical trainees. Depending on clinical project progress this may be delayed for some protocols.
- Core faculty will provide feedback on submitted protocol shell during session 5 (10 minutes each).
- Revise sections 1-6 of protocol based on feedback from second session
- Draft protocol sections 8 (assessments – other than adverse events) and 9 (statistical analysis plan)
- Biostatistics trainees (if applicable for the group) should upload a revised SAP for each project. Ideally, this will happen prior to the session and this can be reconciled with the protocol text for this area.
Session 7: Adverse Event and Data and Safety Monitoring, and Interim Analyses (which will be tracked?, which are SAEs?)
- Revise sections 8 and 9 of protocol based on feedback from prior session
- Draft protocol section 8 (adverse events)
Session 8: Final Statistical Analysis Strategy (sample size detailed, primary analysis, secondary endpoints, exploratory analyses)
- Revise section 9 of protocol based on feedback from prior session
- Prepare range of power over a range of sample sizes
(Note some small groups may not be able to schedule a 9th session or may need to use the 9th session on additional protocol development.) Please complete a draft budget prior to the residential course.
- Review the following article: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2793732/
- Review the following website and look at the schema examples: https://research.unc.edu/files/2016/08/KOURY-AND-MCCOLL-3500-Budget-Development-2016-OSR-Symposium.pdf
- Prepare budget and personnel justification draft. (Consider getting an example from your mentor and/or your departmental research administrator).
- Turn draft budget in to core faculty members at least 48 hours PRIOR to session 7 or the residential course by uploading the assignment to Box.
We recognize that not all elements of the design, sample size and statistical analysis plan will be worked out after the small group sessions. It is important to attempt to fill out as much of a complete protocol template as possible, so that it will be feasible for you to revise and finalize this document while you are at the residential course.
NOTE: Some elements of the protocol template may not apply (or may not seem to apply) for early phase trials so please mark sections as not applicable. These sections will be deleted when you finalize the protocol.
- Prepare first complete draft of your clinical trial protocol.
- Turn draft protocol in to core faculty members by uploading to Box.