Cardiovascular event adjudication during COVID-19 and Beyond

Life Sciences, Clinical Trials, Drug Discovery & Development,
  • Friday, May 21, 2021 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

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 has the power to enhance the scientific validity of cardiovascular trials by allowing consistent assessment of cardiovascular events and employing standardized definitions across trial sites. The ability to virtualize processes is study specific and the experience gained during the pandemic will have a lasting effect on future cardiovascular trial design and 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

Speakers

http://C.%20Michael%20Gibson,%20M.S.,%20M.D.,%20CEO,%20Baim%20and%20PERFUSE%20research%20institutes%20at%20Harvard%20Medical%20School

C. Michael Gibson, M.S., M.D., CEO, Baim and PERFUSE research institutes at Harvard Medical School

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.

Message Presenter
http://Jack%20Martin,%20ICON%20plc

Jack Martin, MD, FACC, Senior Director, Cardiovascular Therapeutics, Drug Development Services, ICON plc

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.

Message Presenter
http://Craig%20McLendon,%20ICON%20plc

Craig McLendon, RN, CCRN, Sr. Dir Adjudication & DMC Mgmt., Clinical Research Services, ICON plc

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.

Message Presenter
http://Deirdre%20Albertson,%20ICON%20plc

Deirdre Albertson, Vice President, Project Management, Cardiovascular, Metabolic and Women’s Health, ICON plc

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.

Message Presenter

Who Should Attend?

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

What You Will Learn

  • 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

Xtalks Partner

ICON plc

ICON plc is a global provider of outsourced drug and device development and commercialization services to pharmaceutical, biotechnology, medical device, and government and public health organisations. The company specialises in the strategic development, management and analysis of programs that support clinical development from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently operates from 93 locations in 41 countries and has approximately 16,000 employees.

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