The ICVR was launched in November 2014 at Cornell University as a partnership of over 12 national registries, the FDA, manufacturers, and other stakeholders. The ICVR Leadership Board was established during the first meeting on November 17th, 2014. The second meeting of the ICVR Leadership Board was held on May 25-26, 2015, in Uppsala, Sweden, where the first prospective and retrospective projects of the collaboration were planned. The third meeting of the consortium was held on November 16th, 2015, in New York City, where these projects and analyses were discussed in greater detail.
1. Development and testing of innovative methodological approaches
Registry science is a relatively new field with growing innovations in methodology. Examples include the use of directly linked (with de-identification) versus distributed network analyses, propensity scores, instrumental variables, inverse probability weighting, doubly robust estimation, registry-based randomized control trials, and other epidemiological methods which show great potential for use in medical device research. The ICVR collaborative infrastructure will help to adapt these methods to study vascular devices as appropriate.
2. Forums for discussion: workshops, conferences
The ICVR members will participate in scientific workshops and conferences intended to bring together external parties with relevant expertise to define evidence gaps and questions, datasets, and best practices.
3. Safety studies, surveillance and comparative outcome evaluation
ICVR research and surveillance studies aim to inform stakeholders about real world outcomes of devices including advantages and disadvantages of different surgical techniques, devices and patient/pathology selection for treatment. In the regulatory science environment, ICVR members will develop plans for new registries, registry modifications or existing registry-based studies to inform clinical and regulatory decision making.
4. Collaboration/peer reviewed articles and white papers
The ICVR members will collaborate as co-authors/peer reviewers on reports, manuscripts, white papers, and other communication conveying the results of work performed through the ICVR.« Back
Director, Coordinating/Analytic Center
United States (U.S.) Food and Drug Administration (FDA) Advisors
Jose Pablo Morales
Medtronic, current member Richard Kuntz
Cook Medical, current member Ted Heise
Gore, current member Eve Ross
Courtney Baird« Back