Table 4.

Examples of Pre-Phase III CT Checklist Items

Issue	Resulting Error	Risk Assessment	Acceptable Outcome?
Is Accuracy evidenced for outcome measure(s)? Yes or No?	Inaccuracy of endpoint measures resulting in high variance.	What is the chance that inaccuracy will undermine the validity of the study data set? P = 0….	Is this an acceptable risk? Yes or No?
Is Dosing optimized? Yes or No?	Lack of efficacy if doses are too low or toxicity if too high.	What is the chance that dosing is not optimized for the drug and its efficacy can not be tested? P = 0….	Is this an acceptable risk? Yes or No?
Will sites comply with protocol conditions? Yes or No?	Enrollment of inappropriate patients not fitting protocol criteria.	What is the chance that sites will not comply with protocol conditions? p = 0….	Is this an acceptable risk? Yes or No?
Will investigators comply with prior agreed analysis of primary and secondary endpoints? Yes or No?	Possible introduction of bias with modifications of protocol after study initiated.	What is the chance that the protocol changes will bias the study analyses or interpretations? P = 0….	Is this an acceptable risk? Yes or No?