
- Applied Clinical Trials-10-01-2015
- Volume 24
- Issue 10
Inclusion/Exclusion Criteria Show Minimal Rise
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.
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.
Articles in this issue
about 10 years ago
Top Investigator Lays out Strategy for Avoiding Conflictsabout 10 years ago
Changes Ahead for Informed Consent, IRBs, Transparencyabout 10 years ago
Europe: At Last, the Hunt is On for Trials That Fit Scienceabout 10 years ago
Developing New Alzheimer’s Drugs With a Focus on Patient Safetyabout 10 years ago
A New Look at the Arsenal of Tech Solutionsabout 10 years ago
Human Gene Transfer Studies: What Clinicians Should Knowabout 10 years ago
Death Waivers an Incomplete Picture of Drug Safetyabout 10 years ago
Evaluating the Effects of Therapy Maskingabout 10 years ago
Satisfaction of Healthy Subjects in Phase I Trialsabout 10 years ago
Applied Clinical Trials Digital Edition - October/November 2015Newsletter
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