Cardiovascular Drug Trial Discontinued
Merck's cardiovascular drug vorapaxar study was halted.
In mid-January, a combined Data Safety and Monitoring Board (DSMB) halted one of two Phase III trials of Merck's investigational anti-clotting drug vorapaxar because of increased risk of bleeding—specifically intracranial hemorrhage—in subjects with a history of stroke.
The TRACER study was being conducted by Duke Clinical Research Institute. It was fully enrolled in June 2010 and included 13,000 subjects with non-ST-segment-elevation acute coronary syndrome. TRA-2P, or TIMI 50 as the trial was also known, was fully enrolled in November 2009 and included 26,500 subjects who had previously experienced a heart attack. The study was being conducted by Brigham and Women's Hospital.
The DSMB instructed TRACER investigators to discontinue the study drug in subjects and begin close-out activities. For TRA-2P, investigators were told to discontinue the study drug in those who experienced a stroke prior to entering or during the course of the study. They could continue the study drug in those who entered the trial with a history of a previous heart attack or peripheral arterial disease, an estimated 75% of the subjects.
The www.clinicaltrials.gov identifier for the TRACER trial is NCT00527943, and NCT00526474 for TRA-2P. Peter Kim, PhD, President of Merck Research Laboratories, emphasized in a conference call that the goal of vorapaxar was to find "an antiplatelet agent that we could add on top of standard of care." Vorapaxar is one of the company's key programs in Phase III, and it had anticipated filing for approval this year. While financials were not discussed, at an estimated cost of $26,000 per subject in Phase III trials, this represents a $338 million hit to the company's bottom line.
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.
