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September 7

Defining the Clinical and Regulatory Landscape for Cardiogenic Shock

Meeting Details

Draft Agenda

Reserve your stay by August 18, 2018 to receive our group rate.

October 10

CSRC-DIA Mobile Technologies Think Tank: Use of Mobile Technologies in Clinical Trials for Assessment of Cardiovascular Endpoints

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CSRC Members present at the DIA 2018 Global Annual Meeting

Real World Evidence Studies to Evaluate the Safety and Effectiveness of Therapeutic Interventions - Is the Data Fit for Purpose and How Will You Know?

Mary Jane Geiger, MD, PhD
Presentation Information | Presentation Slides

Cardiac Safety in Drug Development and the Critical Role of Public-Private Partnerships: The Cardiac Safety Research Consortium Model

Rick Turner, DrSc, PhD | Mitchell Krucoff, MD |
Norman Stockbridge, MD, PhD | Philip Sager, MD
Presentation Information

The Cardiac Safety Research Consortium is dedicated to advancing scientific knowledge on cardiac safety for new and existing medical products by building a collaborative environment based upon the principles of the FDA’s Critical Path Initiative as well as other public health priorities.

Upcoming Events

We're planning for the following meetings in 2018:

Summer
August: Follow-up think tank regarding the FDA's draft Guidance for Industry titled, “Assessment of Pressor Effects of Drugs."

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Fall
September 7: Defining the Clinical and Regulatory Landscape for Cardiogenic Shock

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September 26-27: DCRI/Stanford Center for Clinical Research CEC Summit -- CSRC committee chair to moderate

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October 10: Use of Mobile Technologies in Clinical Trials for Assessment of Cardiovascular Endpoints

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News & Updates

CiPA Update, Slides, and Synopsis on Site

Read the June CiPA update from Jennifer Pierson, HESI senior scientific program manager and download the presentation slides and meeting synopsis from our New Advances in the Assessment of Drug-Induced Arrhythmias and the Comprehensive In Vitro Proarrhythmia Assay (CiPA) meeting.

Announcement of Interest in the Domain of Drug Cardiovascular Safety

Read the CSRC statement regarding the FDA's draft guidance.

 

 

 

Never miss a beat.
Follow the cardiac safety conversation on Twitter at @CardiacSafety.
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Initiatives and Projects

For more than a decade, we have made great strides in advancing knowledge of cardiac safety in clinical research through conferences, publications, and research projects. We are currently planning for the following think tanks in 2018:

New Advances in the Assessment of Drug-Induced Arrhythmias and the Comprehensive In Vitro Proarrythmia Assay (CiPA) (Spring)

Understanding Cardiogenic Shock and Defining the Concept of “Pre-shock” (Fall)

  • Concept of "pre-shock" and develop consensus statements for clinical/research use
  • Mechanical circulatory support in treating "pre-shock"

Novel Approaches for the Evaluation of Mobile Technologies in CV Medicine — Scientific rigor, Innovative Methods, Regulatory Acceptance (Fall)

  • Integrating devices into supporting cardiovascular safety and efficacy endpoints
  • Promised efficiencies of mobile technology in clinical trials
  • Device features, patient features, endpoint validation, and regulatory considerations

Submit Your Ideas

SUBMIT YOUR IDEAS FOR THINK TANKS AND PUBLICATIONS

In order to promote the spirit of collaboration the CSRC highly values, we ask that you submit your ideas for future research projects, think tanks, and white papers. By hearing directly from our members, we can ensure that the topics researched, discussed and published are important to you.

HELD 48 SCIENTIFIC MEETINGS PRODUCED 46 PUBLICATIONS COMPLETED 14 PROJECTS, FORMED 6 COLLABORATIVE COMMITTES, CREATED ECG WAREHOUSE & NON-CV CRFs, RESEARCHED VARIOUS CARDIAC SAFETY TOPICS

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Join

CSRC members benefit from engaging in pre-competitive collaboration with cardiac safety professionals on vital research topics and projects. Working together, we have the opportunity to accomplish public health objectives that no single stakeholder could achieve on its own. The CSRC takes to heart the African proverb shared at one of our pediatric safety think tanks:
If you want to go fast, go alone. If you want to go far, go together.

In that spirit, we celebrate our second decade of excellence in
cardiac safety research, and going there together.