The Cardiac Safety Research Consortium (CSRC) is a collaborative partnership of industry, academic and government leaders, dedicated to advancing the scientific study of cardiac safety issues.
The Cardiac Safety Research Consortium (CSRC) provides leadership and guidance for regulators, public and private clinical researchers through an open, interactive forum to collectively address cardiovascular related issues in clinical trials for both new and existing products. The organization offers unique resources and a collaborative structure that allows for valuable contributions to scientific study design, data analysis and interpretation and dissemination to the public.
One of the defining characteristics of effective leadership is creating a structure that embraces collaboration to produce tangible outcomes and provides a path forward to improve the lives of patients. The impact of CSRC and the thought leadership of its members on key cardiac safety research issues has a proven track record of benefiting the global scientific and regulatory community.
CSRC’s non-competitive environment allows for experts to engage in a rigorous, transparent process to define an optimal path forward in the advancement of cardiac safety research, knowledge and excellence.
As a multi-stakeholder and collaborative group of experts, the findings, interpretations and conclusions expressed by the CSRC may not necessarily reflect the views of all members of the stakeholders or the organizations they represent. The CSRC website is intended to be for information purposes only and is not intended as endorsement of specific commercial technologies, entities, products or services in any respect.
Scientific Rationale and Key Objectives
Safety is a critical component of medical product development and approval. In particular, cardiac safety has received intense focus with several high-profile issues resulting in market withdrawals. These events have stimulated debate over the best way to measure efficacy while ensuring the protection of public health. At the center of this debate is the balance between efficacy and safety. Rapid advances in therapeutic medical product development have yet to reach full potential, in part due to limitations in our ability to understand and quantitate therapeutic balance.
Unfortunately, the evaluative sciences surrounding medical product approval have not kept pace with our fundamental understanding of disease. Societal investment in research and development to improve the approval process lacks in contrast to the large public and private investment in basic research and specific product advances. To improve the ability of regulatory agencies to promote and protect the public health, there needs to be a fundamental investment in the evaluative sciences. Specifically, the scientific basis of our understanding of medical product safety needs to be enhanced and integrated with refined measurements of efficacy. An investment in the evaluative sciences will provide more precise, science-based information, enabling healthcare professionals and patients to appropriately assess risks and benefits.
The FDA’s Critical Path Initiative (CPI) addresses many of these issues by establishing greater collaboration among regulators, academics, physicians, and scientists from industry. The spirit of this collaboration creates opportunities by sharing existing knowledge and data that will facilitate the process of enhancing, refining, and ultimately improving the process used to evaluate new medical products. A central tenet to CPI is a focus on the evaluative science of the approval process, including both efficacy and safety measures.
One of the CSRC’s core principles is to bring together key constituencies to focus on cardiac safety issues during the new medical product development process. Utilizing the principles of CPI, CSRC will focus on improving the evaluative sciences, specifically in relation to cardiac safety.
- Facilitate focused pragmatic research that will inform regulatory processes with regard to cardiac safety.
- Establish expert consensus around common nomenclature, standards, and key definitions, and draft white papers in challenging areas, describing what is known and unknown. Propose a path forward to address knowledge gaps.
- Develop knowledge and strategies intended to improve the evaluative sciences in relation to cardiac safety and product development.
- Coordinate think tanks, scientific meetings, and public forums for open discussion and updates on topics in cardiovascular safety pertaining to drug and device development.
- Foster infrastructure and operational processes with the following components:
- Transparent processes that promote dialogue, cross-sector interaction, and problem solving.
- Inclusion of broader public or patient groups in the process as appropriate.
- Input from all primary stakeholders (e.g., FDA, industry, academia, NIH).
- Involvement from all consortium contributors (i.e., private partners who help fund the consortium’s activities) in the decision-making and project development process.
- Resources and expertise from multiple public and private partners.
- Open and efficient method for submitting potential projects and their objective evaluation.
- Facilitation, and where appropriate, orchestration of mechanisms for continuance of ongoing cardiac safety research programs.
- Utilization of previously conducted and ongoing clinical studies, research infrastructure and databases.
- Preservation of proprietary interests.
- Agency for Healthcare Research and Quality (AHRQ)
- Centers for Medicare and Medicaid Services (CMS)
- European Medicines Agency (EMA)
- Health Canada
- Medicines and Healthcare Products Regulatory Agency (MHRA) (UK)
- National Institutes of Health (NIH)
- Pharmaceuticals and Medical Devices Agency (PMDA)
- US Food and Drug Administration (FDA)
Professional Scientific Organizations
- American College of Cardiology (ACC)
- American College of Clinical Pharmacology
- American Heart Journal (AHJ)
- Comprehensive In Vitro Proarrhythmia Assay (CiPA) Initiative
- Drug Information Association (DIA)
- European Society of Cardiology (ESC)
- Health and Environmental Sciences Institute (HESI)
- InformaConnect (formerly Center for Business Intelligence)
- International CardiOncology Society (ICOS)
- IQ Consortium
- Latin American Society of Interventional Cardiology (SOLACI)
- Safety Pharmacology Society (SPS)
- The Pediatric and Congenital Electrophysiology Society (PACES)
- The Society for Cardiovascular Angiography and Interventions (SCAI)
Patient Advocacy Organizations
- Anthony Bates Foundation
- Championship Hearts Foundation
- Cody Stephens Foundation
- Eric Paredes Save A Life Foundation
- Heart Screen NY
- Heart and Stroke Foundation
- Heart Rhythm Society
- Louis J. Acompora Memorial Foundation
- National Collegiate Athletic Association (NCAA)
- Nicholas Ryan Over Foundation
- Nick of Time Foundation
- Parent Heart Watch
- Peyton Walker Foundation
- Play for Jake Foundation
- Saving Hearts Foundation
- Screening America
- Simon’s Heart
- Thomas E Smith Foundation
- Youth Heart Check
- Who We Play For