Report Card

CSRC report cards provide a brief overview of the events, meetings, and accomplishments held and achieved over the past 12 months. These documents also give a glimpse at the year ahead, revealing topics and areas of study we aim to cover in the coming months.

Year Highlights Report Card
2017
  • 1 Co-Sponsored Meeting
  • 2 Think Tanks
  • 5 Publications
2017 CSRC Report Card
2018
  • 2 Think Tanks
  • 1 Pilot Project Meeting
  • 3 CiPA Steering Team Meetings
2018 CSRC Report Card

2013 CSRC Accomplishments

Overall Numbers

  • Over 600 Industry participants
  • 50 Professional Society participants
  • 220 Regulatory Agency participants
  • 250 Academic Faculty participants

42 Member Companies

Regulatory Collaborators

  • FDA
  • NIH
  • PMDA Japan
  • Health Canada
  • European Union

Society Collaborators

  • ACC
  • The Health and Environmental Services Institute (HESI)
  • SCAI
  • Heart Rhythm Society
  • Agency for Healthcare Research and Quality
  • Canadian Heart Association
  • Center for Business Intelligence
  • DIA
  • European Society of Cardiology
  • International Society of Cardioncology
  • Latin American Society of International Cardiology

 

Publications

  • 19 White Papers published in the American Heart Journal
  • 3 papers published in other journals- British Journal of Clinical Pharmacology and Annuls Noninvasive Electrocardiology, JACC Intervention
  • Press Publications: MedPage, Pink Sheet, FDA Registry, Oncology Today have all covered our meetings.

 Projects

  • ECG Warehouse with over 5 companies sharing placebo data to develop test datasets.  This database has been used by at least 4 companies to test algorithms etc.  –Cindy Green is co-chair of the Database Committee
  • DAPT Trial
  • SAFE PCI- Managed at DCRI
  • Development of CRF Forms for Non-Cardiovascular Trials
  • CSRC/IQ  Clinical Trial- Prospective Phase 1 Clinical Trial being managed by ICON
  • Development of Pediatric ECG Warehouse- work has begun.  Community Foundations, FDA, Lilly, GSK, Mortara, ERT currently involved.  Jennifer Li, Salim Iddress, Barry Magnum, and Danny Benjamin from Duke will also work on this project.

Meetings

  • 28 Scientific Thinktank Meeting
  • Content Provider for DIA Meeting and complimentary booth given 3 consecutive years Co- Sponsor Meetings with DIA and CBI

Thinktank Meetings 2013

  • CSRC/HESI Thinktank Meeting: Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development without the Thorough QT Study – Over 200 participants
  • TREAT IV Meeting- Follow Up to SAFE PCI Meeting
  • CEC Adjudication Thinktank Meeting- about 100 participants
  • CSRC/ ICOS Annual Meeting- Over 200 participants

Thinktank Meetings 2014

  • CSRC Outcomes Thinktank
  • COPD Thinktank
  • Anticoagulation- Induced Bleeding and Reversal Agents Thinktank Meeting
  • CSRC/ IQ Meeting- Being planned
  • CSRC/HESI Thinktank Meeting: Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development without the Thorough QT Study- Follow up Thinktank Meeting- Meeting being planned.

 

Other Important Facts

  • CSRC work has led to MDEpiNet being award to DCRI
  • Preferred agreement with American Heart Journal
  • Preferred agreement with DIA
  • Perosphere one of speakers at thinktank meeting which has furthered our relationship with this company.

Operational Finances

Cash on Hand-   507,046.19 

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

CSRC White Paper Open Forum

Dear CSRC Members:

 

The CSRC Executive Committee is cordially inviting you to participate in an open forum meeting on February 29, 2012 from 8:30am-12:00pm EDT at the FDA’s White Oak Facility to review the draft white paper entitled “Cardiac Imaging Approaches to Evaluate Drug-Induced Myocardial Dysfunction and Heart Failure” led by Dr. Jennifer Christian of GSK with extensive input from members of academia, industry and the FDA.  This draft white paper was developed under the auspices of the CSRC and we are seeking your feedback on the content of this draft document prior to finalization and publication.  All members of the CSRC are welcome to attend this face to face meeting; space is limited so registration will be on a first come basis.  The draft document that will be discussed will be distributed after registration for attendance.

We look forward to your participation.

CSRC 2012 Accomplishments

  • 2012 Accomplishments
      • 6 White Papers Published
      • Presented at AHA on CardiOncology: Co-Sponsored Session with International CardiOncology Society
      • Represented at DIA Japan which resulted in PMDA joining CSRC
      • Co-Sponsored 4 meetings with Center for Business Intelligence (CBI), Drug Information Association (DIA) and American College of Toxicology
      • Launched 3 Thinktank Meetings on QT Assessment, Blood Pressure and Tranradial Approach for PCI and Bleeding
      • Conducted Open Forum Meeting on Cardiac Imaging and Cardiotoxicity in conjunction with the FDA
      • Face to Face Meeting to launch Diabetes Warehouse Project
      • Initiation of the Case Report Forms for Non-Cardiovascular Studies Project.

    Levels of Membership & Fees

     
     

     

    Founding

    (No longer available)

    Sustaining

    Principal

    Associate 

    Large Companies

    Market capitalization > $3 Billion

    Or yearly Gross Sales > $1 Billion

     $50,000

    $25,000/year with a 3 year commitment

     $15,000

    $8,000 

    Medium Companies

    Market capitalization of $250 Million – $3 Billion

    Or yearly Gross Sales of $50 Million to $1 Billion

     $25,000

    $10,000/year with a 3 year commitment

     $10,000

     $4,000

    Small Companies

    Market capitalization < $250 Million

    Or yearly revenue < $50 Million

     $10,000

    $4,000/year with a 3 year commitment

     $4,000

     $2,000

    Start-up Companies market capitalization of $0 AND yearly gross sales of $0

     X

     X

     X

     $1,000

    **Sustaining Members can pay fees yearly.

     

     

    How to Join

    There are several membership opportunities within the CSRC that fall under two main categories: Associate Members and Full Members. The Membership Committee determines whether the member (individual, company, or organization) meets the criteria for full membership.

    Benefits

    CSRC's flexibility allows you to explore topics of interest through think tank opportunities and projects, in addition to publishing your findings on cardiac safety through our White Paper Policy. As a member, you have access to information regarding drug and device development and the ECG database as well as collaboration with regulatory agencies and cardiac experts.

    Individual contributors have the opportunity to join CSRC for free. Please contact us for additional information: cardiacsafety@dm.duke.edu.

    Associate Members

    Benefits include:

    • Participation in larger CSRC forums (i.e., annual meetings)
    • Eligibility to lead a research proposal or publication effort in association with a full member

    Responsibilities include:

    • Provide an in-kind donation of choice (e.g., technology, data, or expertise)

    Restrictions include:

    • Ineligible to sit on a CSRC committee
    • Unable to lead a research proposal or publication effort independently

    We encourage new memberships and are open to finding a way for any interested parties to get involved in the work of the consortium. If you are interested in joining the consortium and have any questions about how you can get involved, please contact us at cardiacsafety@mc.duke.edu.

    Full Members

    Benefits include:

    • Eligibility for positions on various CSRC committees
    • Participation in CSRC meetings
    • Involvement on research teams

    Responsibilities include:

    • Agree to participate in consortium activities
    • Provide an in-kind donation of choice (e.g., technology, data, or expertise):

    For-profit organizations are invited to sponsor the consortium and obtain full membership status with a monetary contribution as follows

    Sustaining
    (Full Member)

    Principal
    (Full Member)

    Associate 

    Large Companies

    Market capitalization > $3 Billion

    Or yearly Gross Sales > $1 Billion

    $25,000/year with a 3 year commitment

     $27,000/year

    $8,000/year

    Medium Companies

    Market capitalization of $250 Million - $3 Billion

    Or yearly Gross Sales of $50 Million to $1 Billion

    $10,000/year with a 3 year commitment

     $12,000/year

     $4,000/year

    Small Companies

    Market capitalization < $250 Million

    Or yearly revenue < $50 Million

    $4,000/year with a 3 year commitment

     $6,000/year

     $2,000/year

    Start-up Companies

    Market capitalization of $0 AND yearly gross sales of $0

     X

     X

     $1,000

    **Sustaining Members can pay fees annually.