Why CVOTs Require a Different Approach:
Optimizing Event Accrual to Reduce Trial Delays
About this webinar
Cardiovascular outcomes trials (CVOTs) are among the most complex and resource-intensive studies in drug development, where operational execution can significantly affect timelines, capital efficiency and overall program value. This webinar examines why event-driven studies require a different operating model than traditional Phase III trials and how sponsors can optimize event accrual and trial performance to reduce execution risk, strengthen program value and support timely patient access to new therapies.
Unlike traditional studies with fixed completion timelines, CVOTs are driven by the accrual of major adverse cardiovascular events (MACE) and/or heart failure (CHF)-related events. Success depends not only on rapid enrollment but also on enrolling patients likely to experience qualifying events. Poor patient risk mix, slow event accrual, missed events and patient attrition can extend trial duration, increase costs and delay regulatory submission. This webinar will discuss how statistical engagement, enrollment strategies, event forecasting and recovery planning can improve study efficiency without compromising scientific rigor.
Drawing on new research from the Tufts Center for the Study of Drug Development (CSDD), the featured speakers will review how integrated clinical research and manufacturing execution can improve financial outcomes in large, event-driven Phase III programs. The analysis demonstrated gains in projected program value, shorter development timelines and strong returns on investment across both diabetes and cardiovascular development programs.
The webinar will also explore how operational blinded reporting, statistical monitoring and predictive analytics can optimize large, event-driven CVOTs by tracking patient risk mix, event accrual, retention, missed events, adjudication timelines and data completeness. The speakers will further explore evolving approaches such as cardiovascular event forecasting, eligibility analytics, AI-enabled adjudication and continuous operational feedback to identify risks, inform recovery strategies and improve execution predictability, while emphasizing the importance of experienced cardiovascular teams in maintaining scientific rigor and trial integrity.
Register for this webinar to learn how CVOT event forecasting, integrating clinical execution and data-driven operational strategies can reduce development timelines, strengthen asset value and improve trial performance.
Who should attend
- Biotech and biopharma sponsors interested in cardiovascular studies
- Clinical Scientists
- Clinical Development and Development Operations professionals
- Clinical Operations and Project Management professionals
- Medical Affairs professionals
- Statisticians
What you will learn
- Why CVOTs require a different operating model than traditional Phase III trials. Success depends not just on fast enrollment, but on enrolling the right patient risk mix and maintaining sufficient event accrual over time
- How blinded operational reporting, event forecasting and predictive analytics can identify risk earlier. Monitoring event rates, retention, data completeness, adjudication timelines and patient risk can support timely recovery strategies without compromising trial integrity
- How integrated execution can improve both clinical and financial outcomes. Tufts CSDD research suggests that tighter integration across clinical research and manufacturing can shorten development timelines, improve projected program value and strengthen ROI
Featured Speakers
Paul Collins
Paul brings nearly 30 years of experience in global clinical research and drug development. As Cardiovascular Lead within the Internal Medicine Therapeutic Unit of the PPD clinical research business of Thermo Fisher Scientific, he is responsible for cardiovascular trial and program delivery across the Cardiovascular, Kidney and Metabolic (CKM) therapeutic areas and is a member of the CKM Leadership Team.
Drawing on extensive clinical development, project leadership and strategic partnership experience across therapeutic areas, Paul works with biopharma clients to navigate the evolving cardiovascular development landscape and deliver innovative, effective clinical development strategies.
Peter G. Linde, MD, FASN
Dr. Linde is a clinical development leader with 21 years of experience, currently serving in the Biotech Solutions group at Thermo Fisher Scientific. Previously, he led global teams in strategy/execution of high-value early-phase programs across companies such as Morphic Therapeutics (Lilly), Acceleron Pharma (Merck) and Abbvie, leading to four global regulatory approvals and two company acquisitions. His work experience includes Boston and Bay Area biotechs and he has served most recently as Chief Medical Officer at Morphic Therapeutics and Walden Biosciences, both in the Boston area.
His development experience spans nephrology, transplantation, cardiology, pulmonary, GI, hematology and immunology indications. Peter has two US patents in stem cell biology and extracorporeal organ devices; third and fourth US patents are pending for Sotatercept’s use in Anemia and Pulmonary Arterial Hypertension. Before his industry career, Peter earned his MD at Stanford Medical School and completed his Internal Medicine residency at the University of Pennsylvania, as well as nephrology and transplant fellowships at Massachusetts General Hospital/Harvard. Following this, he was a Clinical Assistant Professor of Medicine at UCSF. At Harvard and UCSF, Peter engaged extensively in and enjoys teaching and mentoring trainees and members of his team.
Bill Dennis
Bill brings nearly 25 years of experience in cardiovascular drug development and outcomes strategy with over 10 years leading CVOTs. He works with innovative biopharma companies to design cardiovascular development programs that generate clinically meaningful evidence and support global differentiation. Bill’s expertise spans CVOTs, endpoint strategy, long-term evidence planning and helping sponsors understand how cardiovascular evidence influences regulatory, clinical and commercial success.
Rakhi Kilaru, MS, MBA
Ms. Kilaru brings over 25 years of clinical trial experience and has led several Phase II-III trials in dermatology, cardiovascular outcomes, neuroscience and inflammatory disorders. She provides input into study design, analyses and leads enterprise-level initiatives. Her research interests and contributions include centralized statistical monitoring tools and scientific surveillance methods.
Ms. Kilaru was at Duke Medicine for 11 years prior to joining the PPD clinical research business of Thermo Fisher Scientific and has co-authored and analyzed data to support several manuscripts published in peer-reviewed journals. She plays an active role in the ASA Biopharmaceutical section and has served as Chair and member of several scientific and leadership committees.
Partner for this event
The PPD clinical research business of Thermo Fisher Scientific Inc.
The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, enables customers to accelerate innovation and increase drug development productivity. Utilizing patient-centered strategies and data analytics, their capabilities cover multiple therapeutic areas and include early development, all phases of clinical development, peri- and post-approval, novel approaches to patient recruitment and investigator sites, and comprehensive laboratory services. Recognized as a global industry leader in accelerating promising medicines from early development through regulatory approval and market access, they serve pharma, biotech, medical device and government organizations with custom-tailored solutions, including full-service partnerships and functional service partnerships. As a strategic partner in clinical development and analytical services, they apply cutting edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies.