MegaTrials (> 5,000 patients)
Although the DCRI conducts trials of all sizes, over 40 percent of our work is in designing and leading large MegaTrials. With more than 25 years of experience in large trials, the DCRI has developed the skills and expertise required to lead global outcomes trials while delivering quality datasets. To fully capitalize on our experience and integrate lessons learned from previous studies, in 2005 the DCRI created an operational business unit completely dedicated to performing global outcomes trials.
Leveraging the DCRI’s reputation for innovative approaches to the design and conduct of phase III/IV studies, our protocols are designed to be implemented in the practice setting, site-friendly, effective, and cost-efficient.
Our quality-driven approach relies on creating a standard of care, an easy-to-follow protocol, a clinically-focused eCRF and associated query rules, and extensive data status reports and comprehensive trial-specific operational reports that drive quality from the point of screening and enrollment all the way through to data collection, drug compliance, complete event ascertainment, consistent event adjudication, and ultimately trial analysis, publication, and regulatory submission. We understand the potential clinical and operational issues based on our previous experiences. This experience, combined with our knowledge of local site challenges for each of our projects, allows our MegaTrials unit to deliver high-quality programs around the world.
EUCLID (Examining Use of tiCagreLor In paD) is a global, event-driven, double-blind, parallel group trial involving approximately 13,800 patients in 28 countries. EUCLID evaluated the efficacy and safety of long-term treatment with ticagrelor compared to clopidogrel for the prevention of atherothrombotic events in older patients with symptomatic peripheral artery disease.
Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab (ODYSSEY Outcomes) is a randomized double-blind trial being conducted in more than 50 countries that compares alirocumab, a novel lipid-modifying anti-PCSK9 monoclonal antibody, with placebo in patients who have experienced a recent acute coronary syndrome and have residual elevated LDL levels despite statin therapy.
The Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) is a placebo-controlled study of the cardiovascular safety of sitagliptin added to usual care in more than 14,000 patients with type 2 diabetes and cardiovascular disease in 38 countries.
The leadership team for the MegaTrials group has more than 20 years of experience at the DCRI.
The typical project leader in this group has a decade of large trial experience as well as numerous years of involvement in bedside patient care. The regional Clinical Research Associate (CRA) team has more than a decade of clinical experience as well as more than 10 years of monitoring experience, while the in-house CRA team has an average of 10 years of experience. Studies are managed within this business unit to leverage the group’s wealth of experience and knowledge in delivering quality large-scale global outcomes trials.
Director, Global Outcomes Commercial MegaTrials
Matthew T. Roe, MD, MHS
Faculty Director, Global Outcomes Commercial MegaTrials