August 1, 2018
The Cardiac Safety Research Consortium (CSRC) is very pleased to announce the signing of a collaborative Memorandum of Understanding with the American College of Clinical Pharmacology (ACCP). 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.
Within the realm of cardiac and vascular safety, a drug’s proarrhythmic liability is evaluated in both nonclinical investigations and clinical pharmacology studies, the latter of which fall squarely within ACCP’s domain of expertise. Given that cardiac safety is a central component of contemporary new drug development, combining the expertise and vision of these two preeminent professional organizations has the potential to be extremely beneficial for biopharmaceutical companies, regulatory agencies and, most importantly, patients.
The first two collaborative activities defined in the agreement are already underway. 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 also occasionally progress to ventricular fibrillation and sudden cardiac death.
Additionally, a CSRC/ACCP sponsored symposium will be held September 25th at ACCP’s 2018 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 firstname.lastname@example.org.