Reasons for Clinical Failures by Phase
Tufts
The Tufts Center for the Study of Drug Development (Tufts CSDD) recently analyzed the reasons for clinical failures for 410 drugs that entered human testing between 2000 and 2009.
The results of this analysis show that commercial viability—as opposed to safety—is the leading cause of Phase I failures. Commercial viability played a diminishing role in the reasons for drugs failing in later clinical phases. Safety issues accounted for one-third of all drugs that failed in Phase I and Phase III studies; and for 17% of all Phase II failures.
Efficacy issues dominated both Phase II and III accounting for more than half of the total drugs that failed (54% and 52% respectively). Tufts CSDD researchers conclude that the ever-changing commercial landscape combined with insights gleaned from later-stage studies conducted among larger patient populations present ongoing drug development risk-dynamics that are difficult for sponsors to anticipate and manage.
—Tufts Center for the Study of Drug Development, https://csdd.tufts.edu/.
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.
Phase III Trial Data Show Subcutaneous Pembrolizumab as Noninferior to IV Keytruda
March 31st 2025Subcutaneous administration of pembrolizumab with chemotherapy demonstrated a nearly 50% reduction in patient chair and treatment room time while maintaining efficacy and safety endpoints compared to intravenous Keytruda.
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.
