August 1, 2018
In July 2018, the American College of Clinical Pharmacology (ACCP) and Cardiac Safety Research Consortim announced the signing of a collaborative Memorandum of Understanding (MOA). CSRC and ACCP will work together to develop, plan and conduct various educational events and programs. The partnership will also develop and produce research and policy statements/position papers relevant to the fields of clinical pharmacology and the cardiac and vascular safety of medical products.
Two collaborative activities defined in the agreement are already underway. First, a group of coauthors from both organizations is preparing a joint position paper on the use of the heart rate-corrected J-Tpeak interval as seen on the human electrocardiogram for purposes of evaluating a new drug’s potential to induce Torsade de Pointes, a rare polymorphic ventricular arrhythmia that typically occurs in self-limiting bursts and can lead to symptoms of dizziness, palpitations, syncope, and seizures. Torsade de Pointes can occasionally progress to ventricular fibrillation and sudden cardiac death.
Second, a CSRC/ACCP sponsored symposium will be held September 25th at the 2018 ACCP Annual Meeting in Bethesda, MD. At the symposium, titled “The Challenging World of Cardiac Evaluation & Utilization of Concentration-QT Analyses of Phase I Data to Waive the Thorough QT/QTc Study Requirement,” Chairs and Faculty Speakers will present industry, academia and regulatory agency viewpoints. ACCP will provide CME & CPE credits for the course.
CSRC and ACCP look forward to the continued opportunities that will arise from this new collaboration. If you are interested in becoming involved in these activities, please contact us at email@example.com.