Related Experiment Video
Updated: Feb 5, 2026
Automated Contraction Analysis of Human Engineered Heart Tissue for Cardiac Drug Safety Screening
Published on: April 15, 2017
Cardiac Safety Research Consortium (CSRC): Cardiovascular Safety and Adverse Event Case Report Forms
Mary Elizabeth Sabol1, John Finkle1, Mitch Krucoff2
11 Global Clinical Safety and Pharmacovigilance, GSK, Collegeville, Upper Providence, PA, USA.
Abstract:
Detection of off-target cardiovascular (CV) effects remains a significant challenge to drug development. Documentation of CV events in non-CV trials is often inadequate to interpret imbalances between treatment arms, which may lead to concerns about potential CV safety "signals." The Cardiac Safety Research Consortium (CSRC) public-private partnership has developed CV case report forms (CRFs) for adverse CV events, including death. These CRFs are intended to encourage collection, as near to the occurrence of an event as possible, of the minimum information necessary to assess, or possibly adjudicate, the event. A broad range of stakeholders (representing industry, academia, and regulatory authorities) developed these forms with the goal of balancing the collection of key information with the resources likely to be available. Use of these forms is optional, and sponsors may modify them. These forms have not undergone any type of "validation" process. The CSRC will continue to sponsor a working group to invite public comment and feedback on these forms.
Insights
New case report forms aim to improve cardiovascular safety assessment during drug development. These tools standardize data collection for adverse events, addressing a key challenge in clinical trials.
Area of Science:
- Cardiovascular Safety
- Drug Development
- Clinical Trials
Background:
- Assessing off-target cardiovascular (CV) effects is a major hurdle in drug development.
- Inadequate documentation of CV events in non-CV trials complicates safety signal interpretation.
Purpose of the Study:
- To introduce standardized Cardiac Safety Research Consortium (CSRC) case report forms (CRFs) for adverse CV events.
- To facilitate the collection of essential information for event assessment and adjudication.
- To address the challenge of inadequate CV event documentation in drug trials.
Main Methods:
- Development of CV case report forms (CRFs) by a public-private partnership (CSRC).
- Involvement of diverse stakeholders including industry, academia, and regulatory authorities.
- Focus on collecting minimum necessary information for event assessment.
Main Results:
- Standardized CRFs are available for optional use in collecting adverse CV event data.
- Forms are designed to balance data needs with available resources.
- Stakeholder collaboration ensured comprehensive development.
Conclusions:
- The developed CRFs offer a structured approach to improving CV safety data collection.
- These forms aim to enhance the reliability of CV safety signal detection in drug development.
- Ongoing public feedback will refine these essential tools.
Related Concept Videos
01:28Survey Safety
01:13Household Wiring And Electrical Safety
01:20Blood Studies for Cardiovascular System I: Cardiac Biomarkers
The essential diagnostic tools for detecting myocardial necrosis and monitoring individuals suspected of having acute coronary syndrome (ACS) include:
Troponins
Troponins, particularly cardiac troponins I and T, are the most precise and sensitive markers of myocardial injury. They are detectable within 4-6 hours of myocardial injury and remain...
01:19Blood Studies for Cardiovascular System II: CRP, Hcy, and Cardiac Natriuretic Peptide Markers
These markers indicate stress or strain on the heart muscle:
Natriuretic Peptides (BNP)
Cardiac myocytes produce these hormones in response to ventricular stretching...
01:24Data Reporting and Recording
01:12Local Anesthetics: Adverse Effects
Once absorbed into the systemic circulation, local anesthetics can affect the organs that depend on the functioning of sodium...