Inclusion/Exclusion Criteria Show Minimal Rise

Few topics occasion the lamentations of clinical trial professionals more than the topic of patient inclusion/exclusion criteria in clinical protocols. ClinicalTrials.gov represents an important public data source to establish baseline numbers of inclusion/exclusion criteria. A review of these publicly available data shows that there is a small increase in the number of commercially funded Phase III inclusion/exclusion criteria per trial, but nowhere as dramatic as is sometimes portrayed in industry press and industry conferences.

Every year, there is a statistically significant 0.41 increase in inclusion/exclusion criteria totals in commercially funded Phase III studies. Although the increase is not large, the mere size of the database itself helps to make even mild changes seem statistically significant. Two MedDRA therapeutic areas, renal and urinary disorders as well as gastrointestinal disorders, differ statistically significantly from the overall trend, evidencing slight declines in the total number of criteria.