2014 CSRC Accomplishments

New Members:

  • Bayer
  • Bioclinica
  • Boehringer Ingelheim
  • Bristol Myers Squibb
  • Celerion
  • CytoVas
  • Portola
  • Vince and Associates Clinical Research

Collaborative Relationships

  • American College of Cardiology (ACC)
  • Drug Information Association (DIA)
  • ILSI Health and Environment Scientific Institute (HESI)
  • International CardiOncology Society (ICOS)
  • Consortium for Innovation and Quality in Pharmaceutical Development (IQ)
  • Safety Pharmacology Society (SPS)

White Papers Submitted to American Heart Journal

  • Novel Oral Anticoagulants (NOAC) and Reversal Agents: Considerations for Clinical Development – Troy Sarich, PhD, Submitted
  • “Considerations for Assessing the Potential Effects of Antidiabetes Drugs on Cardiac Ventricular Repolarization: A Report from the Cardiac Safety Research Consortium” – Ingrid Hensley, PhD
  • “Centralized Adjudication of Cardiovascular Endpoints in Cardiovascular and Non-cardiovascular Pharmacologic Trials: A Report from the Cardiac Safety Research Consortium ” – Jonathan Seltzer MD, MBA
  • “Cardiovascular Safety Outcome Trials: A Meeting Report from the Cardiac Safety Research Consortium” – Philip Sager, MD
  • CSRC White paper: Can the Thorough QT/QTc study be replaced by ‘Early QT assessment’ in routine clinical pharmacology studies?—Borje Darpo, MD

Expert Panel Papers: DIA Publications

  • CSRC White paper: Clinical Development Approaches and Statistical Methodologies to Prospectively Assess the Cardiovascular Risk of New Antidiabetic Therapies for Type 2 Diabetes- Mary Jane Geiger, MD

Summary Reports of Thinktanks

Thinktank Meetings

  • Outcomes Thinktank- February 2014
  • COPD Thinktank Meeting- March 2014
  • NOAC Reversal Thinktank Meeting- April 2014
  • CIPA Update Workshop CSRC/HESI/SPS/FDA Meeting- December 2014
  • Can QT Assessment in Early Clinical Development be used to Replace the TQT Study- Presenting Results from the Prospective IQ-CSRC Clinical Study- December 2014
  • NOAC Reversal Agent Thinktank Follow-Up: Post Approval Safety and Effectiveness- February 2015

Projects

  • CRF Forms for Non Cardiovascular Clinical Trials
  • CSRC/IQ Clinical Trial