The COVID-19 pandemic has significantly impacted the ability of clinical researchers to collect data assessing cardiovascular events.
Overview
The COVID-19 pandemic has significantly impacted the ability of clinical researchers to collect data assessing cardiovascular events. Because the SARS-CoV-2 virus is commonly associated with cardiovascular risk, patients may be more reluctant to seek medical attention, resulting in underreporting of cardiovascular events and therefore reduced safety of cardiovascular trials. As such, the industry has increasingly acknowledged the value of digital devices and other methods for remote data capture.
Independent event adjudication is one method that can lower the risk of variation and support consistency in reporting cardiovascular trial outcome events for submission to regulatory agencies. Because of this, event adjudication has the power to enhance the scientific validity of cardiovascular clinic trials. The ability to employ these processes is study specific and the experience gained during the pandemic will have a lasting effect on future cardiovascular trial conduct.
In this webinar, our expert panel will discuss:
- Best practices for cardiovascular event adjudication
- How to employ standardised definitions across trial sites
- Implications across drug and device trials
- Recent advances in the selection and application of connected devices
- Long term effects of the COVID-19 pandemic on cardiovascular trial design
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Speakers:
C. Michael Gibson, M.S., M.D.
C. Michael Gibson, M.S., M.D. is an interventional cardiologist, cardiovascular researcher & educator. He is the CEO of the combined non-profit Baim and PERFUSE research institutes at Harvard Medical School. The institutes have led over 1,000 studies, published 3,000 manuscripts in the peer review literature, and have led 60 FDA submissions from their network of 7,000 sites worldwide. He is a senior consultant for Boston Clinical Research Institute.
In 2014, 2018 - 2020 Gibson was ranked as one of the world's most highly cited authors in all of science in the past decade by Thomson Reuters. His work has been cited over 107,000 times, and he has an H index of 118 and an i10-index of 469.
Dr. Gibson obtained his BS, MS, and MD degrees at the University of Chicago where he was a Phi Beta Kappa and AOA graduate.
Jack Martin, M.D., FACC
Dr. Martin is board certified in Cardiovascular Diseases and Interventional Cardiology. He has over 35 years of clinical practice and investigational experience. Jack is an experienced consultant for pharmaceutical and medical device companies including all phases of product development including device design, trial design, FDA pre-sub and panel meetings. Dr. Martin has served as study chairman or the coordinating investigator for multiple multicenter international pharmaceutical and device trials.
His previous roles included Assistant Professor of Medicine, University of Pennsylvania School of Medicine, Philadelphia, Chief, Division of Cardiovascular Diseases and Chief of Interventional Cardiology, Main Line Health System. He has served as President and a Board Member of several research foundations and is a respected educator having served as an Interventional Cardiology Fellowship Program Director. He has numerous peer-reviewed publications, is an active journal reviewer and has been a frequent invited speaker at national and international professional conferences.
While at ICON Jack has provided medical oversight for numerous cardiometabolic studies and has focused on cross functional team building to provide novel solutions for the effective delivery of drug and device trials.
Deirdre Albertson
Deirdre Albertson brings over 25 years of diverse pharmaceutical research and development experience including phase I-IV clinical research, US and global project management, alliance management, Real World Evidence, market research and marketing. Deirdre has implemented clinical research programs worldwide, including the management of resources, processes, and budgets while assuring regulatory compliance and high quality in the conduct of clinical trials. In her current role she supports client relationships, is part of Executive Committees, and provides executive oversight to the management of Cardiovascular and Metabolic projects to ensure teams are meeting their predefined study metrics and providing deliverables of high quality. Deirdre understands the challenges faced by clients to accelerate the development of safe, effective medical treatments for patients with unmet medical needs and has extensive experience in cardiovascular and metabolic indications directing studies using innovative imaging technologies, stem cell treatments, and focusing on Cardiovascular Outcomes Trials (CVOT). She challenges teams to utilise critical thinking to find creative solutions and focus on improving the patient experience. Her therapeutic focus has been in dyslipidemia, acute coronary syndrome, heart failure, end-stage renal disease, and diabetes as well as experience with many rare disease populations.
Craig McLendon, RN, CCRN
Craig McLendon, RN, CCRN is in his 6th year as the Senior Director of ICON’s IDEA group and responsible for all Endpoint Adjudication and DMC oversight at ICON.
Craig is a former Flight and Intensive care nurse working at Duke University for 23 years. He has over 30 years in clinical research experience in both Academic and Commercial Research Organizations. He has served as a CRA, Data Manager, Endpoint Lead, Project manager, and Senior Director. Craig has a passion for evidence-based medicine to improve healthcare throughout the world.
Audience
This programme will be beneficial for pharmaceutical, medical device, and biotechnology professionals working in:
- Clinical Affairs
- Clinical R&D
- Clinical Research
- Clinical Pharmacology
- Clinical Operations
- Project Management
- Regulatory Affairs
- Medical Affairs
- Outsourcing and procurement