Table 2.

Final 15 question quality checklist resulting from the whole selection procedure, with percentage of actual reporting in the 103 peer-reviewed journal articles describing phase I oncology trials published from January 1999 to April 2005

Focus	Questionnaire for reporting phase I dose-finding cytotoxic oncology clinical trials	Percentage of reporting
Objective	Was the objective to find a MTD or a recommended dose for phase II trials?	95.1
	Was the MTD associated with a prespecified toxicity rate?	80.6
	Was the toxicity related to the drug only used to define the MTD?	70.9
	Was the measure of toxicity based on international grading systems such as OMS or NCI scales?	95.1
	Was the trial disease oriented?	53.4
Design	Was the starting dose specified?	99.0
	Was the first dose level justified from preclinical or clinical data?	28.2
	Was the number of dose levels clearly mentioned in the study design?	97.1
	Did the choice of the distinct levels explained?	48.5
	Was the dose allocation method clearly described?	89.3
Analysis	Were all included patients analyzed?	72.8
	Were doses and responses clearly reported?	68.9
	Did the dose allocation along the trial match the described method?	45.6
	Was the estimated MTD or the recommended dose level associated with a measure of variability?1	0.0
	Was the process of estimating the MTD or recommending the dose for future trials clearly explained?	56.3

¹One expert suggested dropping this item.