Representation of Patients with Cardiovascular Disease in Pivotal Cancer Clinical Trials

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.