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Circulation. 2019 Mar 18. doi: 10.1161/CIRCULATIONAHA.118.039180. [Epub ahead of print]

Representation of Patients with Cardiovascular Disease in Pivotal Cancer Clinical Trials.

Author information

1
Ohio State University, Columbus, OH.
2
Cardiovascular Diseases, The Ohio State University, Columbus, OH.
3
Hematology/Oncology, UT Southwestern, Dallas, TX.
4
Internal Medicine, Ohio State University, Columbus, OH.
5
Biomedical informatics Department, The Ohio State University, Columbus, OH.
6
Division of Cardiology, Baylor College of Medicine, Houston, TX.

Abstract

Cardiovascular disease (CVD) is increasingly common among new cancer patients, with a reported prevalence near 30% at diagnosis.1,2 Cancer patients with concurrent CVD have poorer outcomes than those without CVD.1-3 Despite the high prevalence of CVD and its prognostic significance, there is limited evidence to guide the care of this increasing population. One possible explanation may be the exclusion of CVD patients from clinical trials.3 In the US, pivotal clinical trials of anticancer drugs are reviewed by the Food and Drug Administration (FDA) for adequate representation and safety prior to approval and release.4 However, whether patients with CVD are well-represented in these important clinical trials is unknown.

KEYWORDS:

Cardio-Oncology; FDA

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