1. The QT warehouse is now fully functional with more than 35,000 placebo and moxifloxacin waveforms available in the public domain to support exploration of better, more automated, less expensive modalities of QT/QTc assessment. This warehouse will continue to grow through the now established mechanism for FDA to add Thorough QT studies as they are submitted to the agency. Evaluation of QT safety affects all new molecular entities, for all manufacturers.
2. Public-private partnership Thinktank-Incubators: The CSRC has developed topical thinktanks that have brought together all stakeholders, and has created a collaborative, solutions-oriented approach intended to have broad public health impact, as well as to benefit industry needs. The CSRC’s unique expertise in the arena of "obligatory drug-device safety interactions" include:
a. Dual Anti-Platelet Therapy Duration and DES thrombosis DAPT Study: serial thinktank incubators led to the Advamed RFP that is now going forward as a Harvard-led 16,000 patient IDE supported by 6 industry vendors to address this unique public health question. Once the primary endpoint is reported these data will become part of a public domain data warehouse to leverage future questions about optimal duration of DAPT and DES platforms.
b. National Registry for Atrial Fibrillation Ablation Safety: This thinktank conducted in April 2009, was launched through the coordinated efforts of CSRC, FDA, American College of Cardiology, Heart Rhythm Society, and Advamed. The registry structure (using the ACC-NCDR registry infrastructure with results reporting in the public domain) is planned to facilitate "nested" randomized trials including optimal drug and technique studies. In January of 2010, a follow up incubator in conjunction with the Boston Atrial Fibrillation Symposium is planned to address expanding the scope from safety in ablation populations, to safety in management of all atrial fibrillation.
c. CSRC-HESI Annual Meeting 2008: Integrating Clinical and Pre-Clinical Issues in Cardiac Safety: Translational Medicine Meets Critical Path. This thinktank was a first-in-kind educational collaboration between the Cardiac Safety Research Consortium (CSRC) and the Health and Environmental Sciences Institute (HESI) providing an open thinktank forum integrating pre-clinical and clinical challenges of cardiac safety evaluation of new medical therapeutics. Faculty experts from academia, industry and FDA gathered to discuss key topics in cardiac safety assessment from pre-clinical and clinical perspectives, with a particular focus on the translational “gaps” between these two areas of expertise. A meeting proceedings white paper emanating from this thinktank is currently in press in the American Heart Journal.
3. Peer Review Publication "White Papers" Addressing Pre-competitive Issues in Cardiac Safety: In conjunction with Elsevier and the senior editors of the American Heart Journal, CSRC has launched a new genre of publications including pan-stakeholder views on key areas of cardiac safety evaluation. Both an editorial “New Precompetitive Paradigms: Focus on cardiac safety (with industry, academic and FDA co-authors) and the first white paper on cardiac safety evaluation in oncologic agents (“Assessing proarrhythmic potential of drugs when optimal studies are infeasible”) have been published in the American Heart Journal. A second manuscript, Current challenges in the evaluation of cardiac safety during drug development: Translational medicine meets the Critical Path Initiative" is currently in press in AHJ.
29-30 October 2009 CSRC Annual Meeting Program and Slides
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