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.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
