Outline (for two-stage applications) or full (where the grant application requests funding and time to design and set-up the model)
Full (where the grant application does not include time to design and set-up the model)
Reference to key TiTE-CRM literature and a brief explanation of why this design is being used, as reviewers may not have encountered it before.
X
X
Sample size. If this is not fixed, provide an upper and lower bound.
X
X
If not confirmed, add a note to say it will be confirmed after further simulations have been undertaken.
Dose-limiting toxicities
X
X
Target toxicity level
X
X
Include justification and how this was determined.
Dose-toxicity curve
X
Number of dose levels
X
X
Include an estimate if this is not yet known.
Starting dose level
X
Stopping rules
X
Any restrictions on recruitment or dose escalation
X
Software or packages used to set up the model and perform simulations
X
Information on simulations to be performed
X
Include details of toxicity timing and recruitment rates
Simulation results
X
Include details of toxicity timing and recruitment rates
How the data will be used throughout the trial to determine dose decisions
X
Discuss the role of the safety review committee and how late toxicities will be incorporated in the trial. Explain that dose decisions are not made solely by the TiTE-CRM model.
