Table 3.

ClinicalTrials.gov Quality Review Criteria.

Quality Review Criterion	Description	Example	Comment
Lack of apparent validity	Data are not plausible on the basis of information provided	Outcome measure data: mean value of 263 hours of sleep per day	Measure of mean hours per day can have values only in the range of 0 to 24, so value of 263 is not valid
Meaningless entry	Information is too vague to permit interpretation of data	Outcome measure: description states “clinical evaluation of adverse events, laboratory parameters, and imaging”; data reported as 100 and 96 participants in each group	Data are uninformative; unclear what counts of 100 and 96 participants refer to; description of outcome measure not sufficient for an understanding of the specific outcome
Data mismatch	Data are not consistent with descriptive information	Outcome measure is described as “time to disease progression”; data reported as 42 and 21 participants in each group	A time-to-event measure requires a unit of time (e.g., days or months)
Internal inconsistency	Information in one section of record conflicts with or appears to be inconsistent with information in another section	Study type is “observational,” but study title includes the word “randomized”	Randomized studies are interventional, not observational
Trial design unclear	Structure of tables and relevant group names and descriptions do not permit a reader to understand the overall trial design or do not accurately reflect the design	Results modules: participant flow and baseline characteristics entered as a two-group study with a total of 400 participants; outcomes entered for three comparison groups with 600 participants	If there is a third group, this should be reflected in the description of participant flow and baseline characteristics