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.

CSRC Five Year Report

CSRC_FiveYearReport 3.7.12 (PDF download)

Membership Charter

CSRC Membership Charter 2018

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

Membership Charter

Application for Membership

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