According to Dr. Meurer:
This is our website. We have links to many of past lectures and webinars – searching Google for CTMC specific aims also will provide a great webinar from Robert Silbergleit on that.
While traditionally thought of as reporting guidelines, the CONSORT extensions can provide a GREAT overview of elements of a design when developing an early phase trial design. The pilot/feasibility and non-pharmacologic intervention ones are helpful – and over and above the checklist – the elaboration statements are very helpful.
This is a great guideline for developing clinical trial protocols.
This is a set of resources for making clinical trials more efficient.
This is the website for the open-access journal trials. A number of trial protocols are published here (I am an associate editor).
This folder contains two versions of a grant for an R01 that is currently an ongoing single site trial. There are many parts of the grant included, as well as the protocol located in a subfolder. Two summary statements from when the grant was submitted (and not funded) as an R34 are included. In addition, there is a summary statement from the funded R01, and the grants before and after reviewer concerns were addressed.
In addition, I highly recommend searching for high impact journal articles in the relevant field and pulling the protocols written for those trials which are required appendices for NEJM, JAMA, etc. While such protocols are for definitive studies, a lot can be adapted for monitoring adverse events and how to measure outcomes, and other study procedures that are relevant to early phase trials in the same condition.
Finally, I highly recommend searching both NIH reporter (for funded grants) and clinicaltrials.gov to see what other sort of on-going work exists in the specific field.