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Cardiovascular Damage in Clinical Trials

  • Enrico Bronte
  • Giuseppina Novo
  • Viviana Bazan
  • Christian Rolfo
  • Stefania Gori
  • Antonio Russo
Chapter
Part of the Current Clinical Pathology book series (CCPATH)

Abstract

The Cardio-oncology field has grown considerably in the last two decades. The remarkable increase in the number of molecules used in oncology has brought with it a huge set of cardiovascular adverse events. For this reason, it is necessary to intervene on the early stages of drug development. This is what the Food and Drug Administration aims to do. This purpose can be achieved through a more careful analysis of the adverse event, development of guidelines, and identification of objective parameters that could guide the researcher in defining precisely the adverse event. It is also necessary to use additional methods not yet used in clinical trials that can allow an early detection of adverse events and to highlight subclinical damage. These measures will allow the researcher to intervene and treat them even before it can expose the patient to more serious complications or the drug can determine deaths in the post-marketing phase for unacknowledged cardiovascular adverse events.

Keywords

Cardio-oncology Cardiotoxicity Clinical trial Damage FDA CTCAE PRO 

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Enrico Bronte
    • 1
  • Giuseppina Novo
    • 2
  • Viviana Bazan
    • 3
  • Christian Rolfo
    • 4
  • Stefania Gori
    • 5
  • Antonio Russo
    • 1
  1. 1.Department of Surgical, Oncological and Oral Sciences, Section of Medical Oncology, University of PalermoPalermoItaly
  2. 2.Division of CardiologyBiomedical Department of Internal Medicine and Specialities (DIBIMIS), University of PalermoPalermoItaly
  3. 3.Department of Experimental Biomedicine and Clinical Neuroscience, University of PalermoPalermoItaly
  4. 4.Phase I – Early Clinical Trials Unit, Oncology Department, Antwerp University HospitalAntwerpBelgium
  5. 5.Medical OncologyOspedale Sacro Cuore Don CalabriaNegrar (Verona)Italy

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