Assessing cardiac safety in oncology drug development - 14/07/19
Doi : 10.1016/j.ahj.2019.04.010
Jonathan H Seltzer, MD, MBA, MA a, ⁎ 
, Gary Gintant, PhD b, Laleh Amiri-Kordestani, MD c, Jack Singer, MD d, Luana Pesco Koplowitz, MD, PhD e, Javid J Moslehi, MD f, Ana Barac, MD, PhD g, Anthony F. Yu, MD h
, Gary Gintant, PhD b, Laleh Amiri-Kordestani, MD c, Jack Singer, MD d, Luana Pesco Koplowitz, MD, PhD e, Javid J Moslehi, MD f, Ana Barac, MD, PhD g, Anthony F. Yu, MD h a ACI Clinical, Bala Cynwyd, PA
b Abbvie, North Chicago, IL
c FDA, Silver Spring, MD
d Washington State University, CTI Biopharma, Seattle WA
e DUCK FLATS Pharma, Elbridge, NY
f Vanderbilt University Medical Center, Nashville TN
g Georgetown University/Medstar Health, Washington DC
h Memorial Sloan Kettering, New York NY
⁎Reprint requests: Jonathan Seltzer, MD, MBA, MA. Acknowledgement to Jill Dawson for helping to draft the manuscript
Plan
| This white paper, drafted by members of the Cardiac Safety Research Consortium (CSRC), examines key issues related to detection, assessment, and risk mitigation of cardiac safety signals in oncology drug development. This was the subject of a CSRC Think Tank held on October 24-25, 2017, at the United States Food and Drug Administration headquarters in Silver Spring, MD. The goal of the meeting was to recommend best practices in detection, assessment, and mitigation of these safety signals. This paper summarizes discussions at the Think Tank, focusing on the current state of knowledge and future directions for cardio-oncology—the intersection of cardiovascular disease and oncology—to help reduce cardiovascular morbidity and mortality in cancer survivors. |
© 2019
The Author(s). Publié par Elsevier Masson SAS. Tous droits réservés.
Vol 214
P. 125-133 - août 2019 Retour au numéro
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