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?
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
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.
We're planning for the following meetings in 2018:
August: Follow-up think tank regarding the FDA's draft Guidance for Industry titled, “Assessment of Pressor Effects of Drugs."
September 7: Defining the Clinical and Regulatory Landscape for Cardiogenic Shock
September 26-27: DCRI/Stanford Center for Clinical Research CEC Summit -- CSRC committee chair to moderate
October 10: Use of Mobile Technologies in Clinical Trials for Assessment of Cardiovascular Endpoints
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Read the CSRC statement regarding the FDA's draft guidance.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.
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
- Arrhythmia Normal Limits Combined Holter/12 Lead ECG Analysis
- CSRC Prevention of Sudden Cardiac Death in the Young: National Cardiac Screening Warehouse Pilot Study
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.
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.