Inclusion/Exclusion Criteria Show Minimal Rise
Applied Clinical Trials
A review of public data indicates a small increase in Phase III inclusion/exclusion criteria per trial over a five-year period.
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.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Zerlasiran Achieves Significant Sustained Reduction in Lipoprotein(a) Levels with Infrequent Dosing
November 20th 2024Zerlasiran, a novel siRNA therapy, demonstrated over 80% sustained reductions in lipoprotein(a) levels with infrequent dosing in the Phase II ALPACAR-360 trial, highlighting its potential as a safe and effective treatment for patients at high risk of cardiovascular disease.
