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ACCP/CSRC Collaboration
About
The American College of Clinical Pharmacology
®
(ACCP) and the
Cardiac Safety Research Consortium (CSRC)
are pleased to announce the signing of a collaborative Memorandum of Understanding. ACCP and CSRC 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 drug, cardiac and vascular safety, a drug’s proarrhythmic liability is evaluated in both nonclinical investigations and clinical pharmacology studies, the latter of which falls 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 under way. 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.
ACCP/CSRC Position Paper
The Potential Role of the J-T
peak
Interval in Proarrhythmic Cardiac Safety
ACCP and CSRC look forward to the continued opportunities that will arise from this collaboration. If you are interested in being a part of this new collaboration, please contact us at
[email protected]
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