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Cardiovascular Damage in Clinical Trials

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Cardiovascular Complications in Cancer Therapy

Part of the book series: Current Clinical Pathology ((CCPATH))

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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.

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Author information

Authors and Affiliations

  1. Department of Surgical, Oncological and Oral Sciences, Section of Medical Oncology, University of Palermo, Palermo, Italy

    Enrico Bronte & Antonio Russo

  2. Division of Cardiology, Biomedical Department of Internal Medicine and Specialities (DIBIMIS), University of Palermo, Palermo, Italy

    Giuseppina Novo

  3. Department of Experimental Biomedicine and Clinical Neuroscience, University of Palermo, Palermo, Italy

    Viviana Bazan

  4. Phase I – Early Clinical Trials Unit, Oncology Department, Antwerp University Hospital, Antwerp, Belgium

    Christian Rolfo

  5. Medical Oncology, Ospedale Sacro Cuore Don Calabria, Negrar (Verona), Italy

    Stefania Gori

Authors
  1. Enrico Bronte
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  2. Giuseppina Novo
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  3. Viviana Bazan
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  4. Christian Rolfo
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  5. Stefania Gori
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  6. Antonio Russo
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Editor information

Editors and Affiliations

  1. Department of Surgical, Oncological and Oral Sciences, Section of Medical Oncology, University of Palermo, Palermo, Italy

    Antonio Russo

  2. University of Palermo, School of Medicine, Palermo, Italy

    Giuseppina Novo

  3. Department of Cardiology, University of Liège, Liege, Belgium

    Patrizio Lancellotti

  4. Temple University College of Science and Technology, Philadelphia, PA, USA

    Antonio Giordano

  5. Cardiology Department, University of Lisbon, Lisbon, Portugal

    Fausto J. Pinto

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Bronte, E., Novo, G., Bazan, V., Rolfo, C., Gori, S., Russo, A. (2019). Cardiovascular Damage in Clinical Trials. In: Russo, A., Novo, G., Lancellotti, P., Giordano, A., Pinto, F. (eds) Cardiovascular Complications in Cancer Therapy. Current Clinical Pathology. Humana Press, Cham. https://doi.org/10.1007/978-3-319-93402-0_20

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  • DOI: https://doi.org/10.1007/978-3-319-93402-0_20

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