Cardiac Safety Research Consortium (CSRC) think tank to bring FDA, EMA and international stakeholders together to reassess cardiovascular safety in oncology trials

Durham, NC, November, 29, 2021 – Cardiovascular Safety Research Consortium (CSRC) will convene a broad group of stakeholders including U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) representatives, clinicians, and industry representatives, to examine the issue of cardiovascular safety in oncology clinical trials through a collaborative Think Tank forum. The virtual meeting, Cardiovascular Safety in Oncology Clinical Trials – Providing Clarity for a New Era of Cancer Therapeutics, is scheduled for Wednesday, December 1, 2021. The meeting is open to all, however, advance registration is required. 

“As the prevalence of comorbid cancer and cardiovascular disease continues to grow, researchers increasingly need to consider cardiovascular risk in the development of novel cancer therapies,” explained Jonathan Seltzer, MD, MBA, FACC, executive director of CSRC. “Whether trials are currently designed to accurately assess cardiovascular safety has become a topic of growing interest among CSRC membership – regulators, clinicians and researchers alike.”

Addressing the issue among the world-renowned panelists will be Laleh Amiri-Kordestani, MD, Director Division of Oncology, CDER, U.S. FDA, and her EMA counterpart, Sigrid Klaar, MD, PhD, who will discuss the regulatory aspects of the issue. Other moderators include Marc Bonaca, MD, MPH (CPC Clinical Research – University of Colorado), Ninian Lang, MBChB, PhD (University of Glasgow, UK), James Januzzi Jr, MD (Harvard Medical) and Mark Petrie, MBChB (University of Glasgow, UK). Click here to see a complete list of speakers and topics for this program.

Following the conference, the meeting committee will develop a manuscript for publication. More information about the paper will be released as it becomes available.

About Cardiac Safety Research Consortium

The Cardiac Safety Research Consortium (CSRC) provides leadership and guidance for regulators, public and private clinical researchers, and industry through an open, interactive forum to collectively address cardiovascular related issues in clinical trials for both new and existing products. The organization offers unique resources and a collaborative structure that allows for valuable contributions to scientific study design, data analysis and interpretation, and dissemination to the public. CSRC’s non-competitive environment allows for experts to engage in a rigorous, transparent process to define an optimal path forward in the advancement of cardiac safety research, knowledge, and excellence. The impact of CSRC and the thought leadership of its members on key cardiac safety research issues has a proven track record of benefiting the global scientific and regulatory community. For more information about CSRC, visit their website or email info@cardiac-safety.org.