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Integrations of Cardiac Endpoints

Jeff Heilbraun Integrations of Cardiac Endpoints in International Clinical Trials. May 2020.

Abstract: 

Bioclinica CTMS

Looking at the pharmaceutical R&D arena, there is continued growth in the field of oncology research.  As with any other field, efficacy is a primary goal and endpoint for developing oncologic agents.  Based on the therapeutic area the approach to safety endpoints is defined through a benefit-risk perspective.  The success in the field of oncology research has been significant and patient’s life expectancy following treatment continues to increase.  It was and is well recognized that many of the oncology therapeutic treatments are cardiotoxic in nature.  With this recognition that some treatments had a cardiac safety profile and that patients were in fact living longer, the medical and scientific community began to focus on the cardiac safety considerations and endpoints and a new specialty arose which incorporated both the cardiovascular safety endpoints as well as the treatment of the cancer, leading to the establishment of the field of Cardio-Oncology.

From a drug development and regulatory perspective there is continued momentum in this focus and specialty which can be seen coming from the American College of Cardiology (cardio-oncology roundtable) to the American Heart Association’s Cardio-Oncology Vascular and Metabolic Perspectives, scientific position paper.

This article will provide insight and direction related to the integration of cardiac safety (ECG and blood pressure) as well as cardiac imaging endpoints into oncology clinic trials.  The article will include a review of the present regulatory considerations as well as an overview of both technologies and modalities for the assessment of cardiac safety and imaging endpoints within a study from a benefit – challenge perspective and how the design and data are positioned to address specific safety endpoints within the unique oncology drug development environment.

 

    

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