Biomedical Engineering Reference
In-Depth Information
Objectives
and
deliverables
To advance scientifi c knowledge on cardiac safety for new
and existing medical products the CSRC will:
•
Facilitate focused, pragmatic nonproprietary research
to inform regulatory processes
•
Create common nomenclature and standards for
cardiac safety evaluation
•
Develop knowledge and improve the evaluative
sciences related to cardiac safety and product
development, specifi cally addressing the use and
qualifi cation of biomarkers for assessing cardiac
safety
•
Establish infrastructure and operational processes to
allow effective sharing of knowledge and resources
while preserving patient's rights and proprietary
interest
•
Develop white papers to address gaps in
cardiovascular safety for drugs and devices
•
Develop a forum for “ think tanks ” to address specifi c
cardiovascular safety issues
Description of
consortium
Investigators are invited to submit and develop research
proposals in alignment with CSRC objectives. The
scientifi c oversight committee then assesses and
approves proposals, establishing teams to conduct the
research, and monitors progress. One example is
analysis of the FDA database of more than 2 million
electrocardiograms (ECGs) from the clinical trial data
submitted as part of new drug applications. The initial
focus will be on proarrhythmic risks, with longer term
development of evaluative tools, standards, validated
tests, and cardiovascular biomarkers related to broader
aspects of cardiac safety, including but not limited to
arrhythmia, thrombosis, myocardial infarction, and heart
failure.
Time frame
Started 2006, no specifi ed end date
Current status
White papers in progress for: evaluation of ventricular
arrhythmias in early-phase drug development; use of
cardiac troponins in drug development; evaluation of
QT for biologics; thorough blood pressure studies;
developing compounds with cardiac safety signal;
autonomic effects on the QT interval; pharmacokinetic/
pharmacodynamic (PK/PD) analysis of QT effects; QT
evaluation for oncology compounds; evaluation of
non-QT ECG safety. Current think tanks: Atrial
Fibrillation; CSRC-HESI; dual antiplatelet therapy
duration
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