6533b85bfe1ef96bd12ba9b0
RESEARCH PRODUCT
Cardiovascular Damage in Clinical Trials
Stefania GoriChristian RolfoGiuseppina NovoViviana BazanEnrico BronteAntonio Russosubject
Cardiotoxicitymedicine.medical_specialtybusiness.industryfood and beveragesEarly detectionClinical trialFood and drug administrationDrug developmentmedicineCardio oncologyIntensive care medicineAdverse effectSet (psychology)businessdescription
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.
year | journal | country | edition | language |
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2018-10-05 |