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International Clinical Trials

Integration of Cardiac Endpoints



Within 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 improve with advanced therapeutic approaches. It has been well recognised that many of the oncology therapeutic treatments are cardiotoxic in nature. This was captured back in 2010 by Albini et al, stating “cardiotoxicity is becoming one of the most important complications of cancer chemotherapy and, sometimes, of cancer chemoprevention. Identification of those patients at higher risk will be one key strategy to reduce the morbidity and mortality from cardiotoxicity”. With the recognition that some treatments had a cardiac safety profile and patients were in fact living longer, the medical and scientific community began to focus on the cardiac safety considerations, and a new specialty arose that 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 clinical care, 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 and development of the online cardiooncology community) to the American Heart Association’s (AHA) Cardio- Oncology Vascular and Metabolic Perspectives scientific position paper. This has also been mirrored in the pharma R&D groups with the integration of a cardiologist within the oncology development team and with the specific therapeutic reference to cardio-oncology. Additionally, working groups such as the Cardiac Safety Research Consortium (CSRC), which includes representation from the regulatory, pharma, and clinical arenas, have conducted think tanks related to cardiac safety and oncology drug development.

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About the author

Jeffrey Heilbraun attended the American University in Washington DC, US, receiving a fellowship and completing his Masters of Science in Health Promotion and Disease Management. Jeffrey completed his Bachelors of Science in Biology at Tufts University, US. He joined Bioclinica in 1993 and has supported activities in data management, operations, and business development. Jeffrey has presented and chaired sessions at the Annual DIA meeting, The Japan DIA Cardiac Safety Meeting, and CSRC. He has also been involved in the biopharma cardiac safety arena for 25-plus years and worked on the publication of several articles specific to the area of cardiac safety in pharma development.
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