In recent years, the development of clinical trials using targeted agents has been stimulated by the identification of pathways involved in carcinogenesis, metastasis and drug resistance and by the emergence of molecular analysis of tumors. These targeted agents are initially investigated as single agents in phase I clinical trials, and, if well tolerated, in phase II and III studies. However, some targeted agents can cause arrhythmia, hypertension,ischemia or left ventricular (LV) dysfunction. Because determining the maximum tolerated dose and dose-limiting toxicity are primary endpoints of phase I clinical trials, many useful targeted agents that cause excess cardiac toxicity might not proceed to phase II trials. Therefore, cardiac risk factors should be taken into account in the selection and management of patients with cancer who are enrolled in phase I clinical trials.
Centralizing electrocardiograms and echocardiograms have become the industry standard for collecting and analyzing these data. Core laboratories act to reduce variability by standardizing collection techniques and reading paradigms. The reduction in variability can result in fewer false positive readings for the sponsor.
In this free webinar, the featured speaker will discuss trends in cardio-oncology, and the implications for detecting cardiac toxicity in clinical trials.
Dr. Tim Callahan, Vice President of Scientific Affairs, BioTel Research
Dr. Timothy Callahan, PhD brings over 30 years of clinical research expertise to his position as Vice President of Scientific Affairs at BioTel Research. His experience includes conducting research in silent myocardial ischemia at the National Institutes of Health in Bethesda, Maryland. An expert in diagnostic testing, Dr. Callahan co-authored two patents in QT interval analysis and a patent in dynamical systems modelling of electrocardiogram (ECG) data. He has authored and co-authored many abstracts and publications as well as served as the moderator for three FDA QT-IRT – ECG Core Lab meetings. Dr. Callahan has attended regulatory meetings and has assisted clients in preparing regulatory submissions.
He is a frequent speaker at pharmaceutical industry functions and sits on several advisory boards for peer-reviewed publications and cardiovascular safety committees for sponsors.Message Presenter
Who Should Attend?
This webinar will benefit medical and non-medical professionals in the biopharmaceutical industry, especially those supporting oncology drug development with roles in:
- Clinical Research
- Clinical Development
- Medical Affairs
- Clinical Operations
- Project Management
- Regulatory Affairs
What You Will Learn
Attendees will learn about:
- Trends in cardio-oncology
- Perspectives from regulatory, academia and industry
- Recommendations regarding the prediction, avoidance and detection of CV safety events in oncologic drug development
- Reducing variability in electrocardiogram/echocardiogram data acquisition and analysis
As an industry leader in testing services for clinical trials, BioTel Research combines the expert medical imaging of VirtualScopics and the cardiac core lab leadership of Cardiocore. BioTel Research offers global operational support for cardiovascular monitoring in all therapeutic areas, and advanced imaging services in oncology, cardiovascular, metabolic, musculoskeletal, neurologic and medical device studies. Their accessible and experienced research team comprises key opinion leaders, board-certified cardiologists and radiologists, sub-specialty scientists, and highly trained technicians — who acquire, evaluate, and report high-quality data through an efficient, cloud-based infrastructure. At BioTel Research, their job is to support your clinical trial with the most accessible and experienced team and the most advanced technologies available… through personal service on a global scale.