If you are a scientist or researcher, including being a crucial member of a team developing innovative cancer therapy, it can be daunting to consider how to establish cardiac safety. With any new therapy, it is imperative to identify the right patient group who will respond well to the cancer treatment. Importantly, avoidance of cardiovascular (CV) complications or strategies to mitigate any impact of these CV events are essential for best practice. Utilizing over 20 years of clinical trial experience in Cardio-Oncology, including authoring multiple multicenter trials, Dr Lenihan can assist and provide direction how to optimally navigate the scrutiny of regulatory bodies for clinical trial success.
Strategy for Optimal Cardiac Assessment Dr Lenihan, outlining a strategy for optimal assessment of cardiac status during cancer therapy, delivered this presentation at the FDA in 2011.
Detecting CV adverse events Dr Lenihan presented a proposed strategy for detecting CV adverse events imbedded into cancer therapy trials during a meeting at the FDA in combination with Oncology leaders in 2016.
Monitoring, Diagnosis and Mitigation of Cardiotoxicity Click Here.
Cardiovascular (CV) adverse events were common in patients receiving proteasome inhibitor therapy for relapsed multiple myeloma, especially with carfilzomib-based therapy, according to results from the PROTECT study.
While prior studies have shown an increased risk for CV toxicities with proteasome inhibitor therapy, detailed descriptions of the events and risk factors have been lacking. “Furthermore, there is no validated protocol to help determine which patients are at highest risk of CV toxicity during therapy, nor is there management guidance for patients who experience a [CV adverse event],” wrote Robert F. Cornell, MD, of Vanderbilt University, Nashville, Tenn., and colleagues in the Journal of Clinical Oncology.
Dr. Lenihan brings a wealth of practical clinical research experience to the development of research trials as indicated in this Phase 1 clinical trial utilizing the cancer research CTCAE criteria to document cardiac safety in new therapeutic for cardiac disease