About the Cardiovascular Sciences Research Consortium
Who we are
The Cardiovascular Sciences Research Consortium (CSRC) is a scientific consortium whose participants include global regulatory agencies, industry professionals, patient advocates, and clinical thought leaders. The CSRC’s publicly shared think tanks and research programs advance cardiovascular regulatory and scientific issues, provide pathways for transformative digital solutions, and accelerate novel cures and therapies for patients.
Our partnership with the FDA enables the CSRC to unite interested constituents to identify and provide frameworks that address regulatory science gaps and de-risk the lifecycle of drugs, biologics, and medical devices from development to implementation.
Advisors
History & Impact
The CSRC was first established as the Cardiac Safety Research Consortium in 2006 by a Memorandum of Understanding between Duke University and the FDA. Since its inception, the CSRC has produced over 50 peer-reviewed publications and multiple research projects. The CSRC think tanks and projects have collaborated with over 40 government, professional scientific, and patient advocacy organizations.
In addition to contributing to public health, the CSRC’s work has produced significant cost savings across the industry. For example, the CSRC’s efforts are notable in rationalizing requirements for conducting formal QT studies and endpoint adjudication.
The CSRC’s efforts have included the need for more efficient means of detecting pro-arrhythmia, considerations for blood pressure and biomarker monitoring, cardiac imaging, and cardiac safety in special populations, such as diabetics, women, and an expanded program focused on pediatric cardiovascular safety.
The CSRC also tackled projects including antidotes for novel oral anti-coagulant agents; enhanced clinical science processes, including registry-based randomized trials; development of a standardized cardiac event reporting structure; use of social media for safety surveillance; and the role of event adjudication for cardiac events.
With the explosion of scientific knowledge, off-target cardiovascular effects, digital technologies, and a focus on diverse populations, the CSRC’s stakeholder concerns have likewise broadened. To better represent this expansion in stakeholders, the CSRC leadership elected to become an independent 501(c)(3) not-for-profit, private-public partner with the FDA.
Additionally, the CSRC acknowledged our stakeholder request to officially go forward as the Cardiovascular Sciences Research Consortium. The CSRC currently has relationships with major cardiovascular clinical trial academic centers in the US and Western Europe, the FDA, Canadian and European regulatory agencies, and private sector companies.
Working with The CSRC
Often, there is ambiguity introduced in the development of new therapies due to the development of new scientific discoveries, the implementation of new technologies, or novel regulatory approaches. These “pain points” are often felt among stakeholders.
The CSRC is dedicated to resolving these pain points, through a relatively simple process:
- Contact the CSRC and alert us to the issue. The issue must be primarily a scientific one, not a commercial one.
- The CSRC will discuss with the FDA and other stakeholders.
- If approved, the CSRC will most likely authorize a publicly available think tank that guarantees participation from experts in the FDA, private sector, academia, and potentially other regulatory agencies. The CSRC may choose to authorize a research project, with similar participants.
- The conclusions of the think tank or research project will be shared publicly with the publication of a peer-reviewed manuscript.