Author + information
- Mitchell W. Krucoff, MD⁎,⁎ (, )
- Roxana Mehran, MD†,
- Gerrit-Anne van Es, PhD‡,
- Ashley B. Boam, MSBE§ and
- Donald E. Cutlip, MD∥
- ↵⁎Reprint request and correspondence:
Dr. Mitchell W. Krucoff, Duke Clinical Research Institute, 508 Fulton Street, Room A3006 Cardiology, Durham, North Carolina 27705
Evaluation of new medical devices and demonstration of their conformity to essential principles of safety and effectiveness frequently require clinical trials in human subjects. For many cardiovascular devices, in particular implantable or invasive devices, ethical, clinical, and logistical constraints must be integrated into the balance of how best to encourage innovation and brisk access to better therapies with potential safety concerns and their evaluation. As device manufacturing and adoption progress throughout the total product life cycle, the ability to aggregate data across individual clinical trials, patient subgroups, or device models adds critical knowledge, in particular with regard to safety. One of the most fundamental barriers to meaningful data aggregation is the use of different nomenclature and definitions of key descriptors and endpoints from 1 trial to another, or from 1 manufacturer to another. Thus, the eventuation of robust, practical consensus definitions and nomenclature represents a manageable and important advance in the quality, speed, and cost of research and development pathways for new devices.
Controversies around optimal definitions for clinical safety and effectiveness outcomes frequently result from variations in sensitivity and specificity limitations related to the evidence available in living human subjects. Consensus definitions do not resolve such controversy, or necessarily represent definitions that are somehow more “right or wrong” than may be available using other options. The consistent use of well-considered consensus definitions throughout the life cycle of a medical device, however, has unique value to scientific, clinical, regulatory, and industry stakeholders and most importantly, to protection of the public health, well beyond the limitations of relative degrees of accuracy or inaccuracy.
Definitions per se are not self-sufficient, but are dependent on how they are used. Thus, optimal consensus definitions and nomenclature may be crafted differently for different purposes. Professional societies or expert panels developing consensus definitions to support practice guidelines, for instance, may prefer different constructs of evidence than a clinical events committee or a data and safety monitoring committee might require for a clinical trial.
The purpose of the Academic Research Consortium (ARC) is to create a dynamic, open-ended, transparent, collaborative forum across stakeholders, whose objective is to develop consensus definitions and nomenclature and related processes, optimized for application in pivotal clinical trials of specific classes of new medical devices, and to disseminate such definitions and recommended processes into the public domain.
The ARC was founded in 2006 as an informal collaboration between 4 academic research organizations—the Harvard Clinical Research Institute (HCRI), Cardialysis, the Cardiovascular Research Foundation (CRF), and the Duke Clinical Research Institute (DCRI), with advisory participation of the U.S. Food and Drug Administration (FDA). Thought leaders from the medical industry were centrally involved as nonvoting stakeholders. The group first focused on key definitions for application to coronary stent studies, conducting a series of think tank meetings and publishing the consensus document in the peer review literature in 2007. Currently, 4 additional ARC efforts are in progress in the areas of key definitions for percutaneous valve studies (valve ARC, or VARC); for characterization of bleeding complications in cardiovascular trials (bleeding ARC, or BARC); and for peripheral intervention (peripheral ARC, or PARC), and for atrial fibrillation (AF-ARC).
The ARC's mission is to promote informed and collaborative dialogue across stakeholders supporting the development of consensus definitions and nomenclature for targeted areas of new medical device development, and to disseminate such definitions in the public domain.
Organizational Composition and Membership
The ARC will comprise a steering group and an open-ended array of focused project teams. The ARC represents a consensual alliance of like-minded professionals, or consortium, not a contracted or legally bound entity.
ARC Steering Group
The ARC steering group comprises appointees from each of the 4 founding research organizations in conjunction with advisory liaison representation from the U.S. FDA. The steering group will function to:
• Coordinate ARC operations in accordance with this charter;
• Review and modify this charter as necessary over time;
• Review and define key focus areas for ARC focused project teams;
• Coordinate and facilitate the planning and content of ARC programs;
• Develop and facilitate ARC project teams; and
• Facilitate milestones and timelines for deliverables.
The Steering Group:
1. Gerrit-Anne van Es (Cardialysis), e-mail:
2. Donald E. Cutlip (HCRI), e-mail:
3. Roxana Mehran (CRF), e-mail:
4. Mitchell W. Krucoff (DCRI), e-mail:
5. Ashley Boam (FDA), e-mail:
ARC focused project teams
Focused project teams will be developed and tasked to address specified areas of medical device development warranting consensus definitions useful for pivotal clinical trial purposes. Specifically, focused project teams will:
• Include 2 project team leaders, at least 1 of whom is affiliated with 1 of the 4 founding ARC research organizations;
• Endeavor to include high-level expertise from all stakeholders relevant to the specific device area of focus;
• Conduct think tanks, teleconferences, and e-mail interactions sufficient to develop consensus definitions; and
• Coordinate and complete the process sufficiently to disseminate such definitions in the public domain through publication in the peer-reviewed literature.
Membership in ARC is voluntary, without dues or contractual obligation. Individuals constituting the ARC steering group are determined by the parent research organizations; the FDA liaison to the ARC steering group is determined by FDA. Members of the ARC focused project teams are determined through participation in the project team functions listed in the previous text, and as coordinated by the 2 project team leaders.
Professional societies and other public domain organizations with overlapping interest areas to ARC programs provide a unique locus of expertise in definitions of key terminology used in guidelines and quality registry databases. Interactions between ARC and professional societies are encouraged through the identification by such societies of individuals to serve as liaisons between ARC efforts on behalf of the society. Processes for naming such liaisons reside within the professional society. ARC recognition of such liaison roles is provided through the focused project team leaders, similar to other voluntary membership roles.
The ARC steering group will conduct meetings, either face to face or via teleconferencing, at least quarterly per annum. Priorities, operations, project selection, finance, and other ad hoc items will be reviewed.
Planning for specific focused project meetings, including meeting location, timing, agenda, and documentation, will be coordinated by the project teams and team leaders, with facilitative oversight from the steering group.
Both in-kind and financial resources will be utilized on an ad hoc basis. All financial transactions, sources, budgets, and use will be fully transparent. In specific settings, resources may also be developed through federal or professional society funding or grants. No personal revenues, honoraria, or other financial incentives or rewards will be provided in conjunction with ARC activities or deliverables.
An annual public meeting will be held and will serve the following primary purposes:
• Provide updates and review of existing focused projects;
• Orchestrate dialogue identifying key areas and priorities for future focused project efforts; and
• Consider the need for changes to this charter.
Focused Project Meetings
Focused project meetings will serve to bring stakeholders together in open dialogue supporting the eventuation of consensus definitions for focused medical device topical areas.
Focused Project Manuscripts
These manuscripts will provide the mechanism for public dissemination of consensus definitions for focused medical device topical areas.
Dr. Mehran is a consultant for and on the Advisory Board for Abbott Vascular, AstraZeneca, OrthoMcNeil, Regado Biosciences, and she received research grant support from Bristol-Myers Squibb/Sanofi-Aventis. Dr. Cutlip is a Principal Investigator for Medtronic. The other authors have reported that they have no relationships to disclose.
- American College of Cardiology Foundation