|BioTelemetry Research||Pfizer, Inc.|
|BioTelemetry Research||Pfizer, Inc.|
|ACI Clinical||High Point Clinical Trials Center|
|AMPS||Johnson & Johnson|
|AtCor Medical||Merck & Co., Inc.|
|Bayer Healthcare Pharmaceuticals||Monebo|
|Biomedical Systems||PAREXEL Informatics|
|BioTelemetry Research||Pfizer, Inc.|
|Bristol Myers Squibb||Regeneron Pharmaceuticals|
|Celerion||Richmond Research Institute|
|Duck Flats Pharma||Taylor Microtechnology|
|Eli Lilly and Company||Vince and Associates Clinical Research|
governance_structure (PDF file for download)
The Executive Committee ensures the CSRC is in concert with its charter mission. In addition, it oversees all committee activities and reviews each committee’s recommendations. The Executive Committee holds final decision making responsibility for all CSRC activities and processes. It also has final responsibility for providing all in-kind and fiscal resources, or strategies and support for obtaining such resources, needed to facilitate each committee’s activities on behalf of the CSRC. The Executive Committee determines replacements for CSRC leadership roles if need be.
The Membership Committee is the primary center of activity that sustains the vitality of the CSRC by recruiting new members and ensuring members have opportunities to participate and contribute to the organization at every level. The committee is responsible for determining membership statuses of new applicants according to stipulations outlined in the membership charter.
The Inter-Organizational Partnership Liaison Committee serves as the CSRC's "single point of contact" for partner organizations and facilitates jointly sponsored meetings and publications. Although partner organizations are not members of the CSRC, they share the neutrality and patient-centered goals of the consortium.
The SOC is the primary intellectual repository for solicitation, review, and ongoing oversight of all scientific projects and programs, making recommendations on each directly to the Executive Committee. The SOC develops and facilitates research teams specifically dedicated to each approved research program.
The Scientific Programs Committee organizes and provides logistical support for all CSRC-sponsored public meetings. Although this committee is separate from the SOC and other committees, it works in an integrated fashion to ensure appropriate topics are raised to the Executive Committee for consideration from various CSRC groups. This committee reviews proposals for annual meetings, think tanks, and other public forums, specifically focusing on meetings that will likely catalyze other sustained efforts such as white papers and research projects. In addition, the Scientific Programs Committee assists in forming specific working groups as needed to provide direction, guidance, administrative support, communications, and involvement with other facets of CSRC.
The White Papers and Publications Committee orchestrates and provides logistical support for all CSRC-sponsored publications. Although this committee is separate from other committees, it is intended to work in an integrated fashion to ensure that appropriate topics are raised to the SOC for consideration from the various CSRC groups. Committee members review proposals for white papers and similar publications, focusing on topics that either emerge from or will likely catalyze other sustained efforts, such as research projects, public meetings, and programs. The White Papers and Publications Committee assists in forming specific writing and reviewer groups as needed to provide direction, guidance, administrative support, communications, and involvement with other facets of CSRC. Committee membership consists of at least industry, academia, and regulators. It reports through the SOC.
ECG data in the ECG warehouse are owned by specific entities. Most typically these are pharmaceutical company sponsors that submit ECGs in the course of drug development or post-market surveillance. In other scenarios, they can be research organizations (public or private) that collaborate with CSRC for shared common scientific goals.
Release of ECG data to CSRC for additional analysis represents a collaborative effort of scientific goodwill on the part of the data owners. Within the CSRC, the ECG Database Committee covers all technical sides related to project proposals (before their submission) and subsequent data analysis (after the projects have been executed). The Scientific Oversight Committee (SOC) evaluates proposals for use of the released ECG data and fosters collaboration within the research community. Individual research protocols cleared by the SOC are then approved by the Executive Committee.
Safety is a critical component of medical product development and approval. In particular, cardiac safety has received intense focus with several high-profile issues, including market withdrawals. These concerns have stimulated debate over the best way to measure efficacy while ensuring the protection of the public health. At the center of this debate is the balance between efficacy and safety. Importantly, 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, scientifically-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 focusing 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.
To advance 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.
The Cardiac Safety Research Consortium (CSRC) was launched in 2006 through an MOU with Duke University to support research into the evaluation of cardiac safety of medical products. CSRC supports research by engaging stakeholders from industry, academia, and government to share data and expertise. Outputs of the CSRC include research projects utilizing waveform data released by the FDA ECG warehouse, think tank programs, and consensus white papers.