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Pilot Study

Meeting

January 12, 2018

Savannah, Georgia

Pilot Study Meeting

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.

13th Annual Heart-to-Heart Meeting

The CSRC Pilot Study Team has partnered with Parent Heart Watch to sponsor a Pilot Study Training session at the 13th Annual Heart-to-Heart Meeting in Savannah, Georgia on January 12th at 3:00 pm EST. During this session, we will have ECG machines available as well as hands-on training from our pilot study leadership group. Registration information and travel information are now available.

NOTE: The training session is by invitation only and has been designed for members involved with the CSRC Prevention of Sudden Cardiac Death in the Young Pilot Study.

Upcoming Events

June 24-28 DIA Annual Meeting in Boston. We will host an engaging discussion on key issues in cardiac safety research.

We're also planning for the following think tanks in 2018:

  • Spring - Evolving Use of Cardiac Biomarkers to Drive Efficiencies in Clinical Trials
  • Summer - Understanding Cardiogenic Shock and Defining the Concept of Pre-shock
  • Fall - Novel approaches for the evaluation of mobile technologies in CV medicine - scientific rigor, innovative methods, regulatory acceptance

News & Updates

Download slides & meeting materials from our October 2017 meeting & think tank

Read the new CSRC white paper: "Is There A Role For Pharmacokinetic/Pharmacodynamic Guided Dosing For Novel Oral Anticoagulants?"

 

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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:

Evolving Use of Cardiac Biomarkers to Drive Efficiencies in Clinical Trials (Spring)

  • Use of cardiac biomarkers for inclusion/exclusion criteria
  • Cardiac biomarkers as surrogate safety/efficacy endpoints
  • The biomarker as a target for therapy

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

  • 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.