Phase I and II
Pablo Morales, MD, U.S. FDA
Robert Thatcher, 4C Medical Technologies
Jack Cronenwett, MD, Society for Vascular Surgery (SVS), Vascular Quality Initiative (VQI)
Misti Malone, PhD, U.S. FDA
Melanie Raska, Boston Scientific
Daniel Bertges, MD, Society for Vascular Surgery (SVS), Vascular Quality Initiative (VQI)
MDEpiNet Key Advisors
Mitchell Krucoff, MD, Duke Clinical Research Institute (DCRI)
Project Management and Informatics Support
Mina Baqai, DCRI,
Sarah Palmer, DCRI
Rebecca Wilgus, DCRI
RAPID focuses on a pre-competitive, stakeholder ecosystem approach to enhanced TPLC evaluation of devices for peripheral vascular intervention. This system was developed by the Predictable And Sustainable Implementation Of National (PASSION) Registries for Cardiovascular Devices program of MDEpiNet. RAPID is currently a formally designated NESTcc Demonstration Program coordinated by the Duke Clinical Research Institute.
RAPID Phase I originated the construct of the “minimum core data structure” for PAD device evaluation, as a re-usable model across NEST-based CRNs supporting efficient systems interoperability. For the Phase I use case in PAD, data elements from pivotal trial and professional society case report forms were leveraged as a starting point to develop and publish in the public domain the core minimum set of data elements to support evaluation of devices used to treat PAD. In parallel, efforts to promote the adoption of GUDID were initiated in the peripheral vascular community. RAPID Phase I was not only completed ahead of schedule, but through this inclusive, productive collaborative effort, good faith and trusting relationships were built between stakeholders throughout the peripheral device ecosystem.
RAPID Phase II developed the most contemporary OPG for devices used in the SFA and femoral-popliteal anatomy available in the PAD literature. The timeline for completion of this OPG was dramatically accelerated and facilitated by the “rapid” implementation of the Phase I minimum core data elements by the VQI registry. This achievement by our professional society partners thus provided the real-world data utilized to update OPC for PAD devices. Results of the Superficial Femoral Artery-Popliteal EvidencE Development OPG were shared in the RAPID stakeholder meeting at the FDA on March 20, 2019 26. These results have currently been submitted for peer review.
RAPID Phase III Pathways was launched in June of 2019 following the FDA’s Special Advisory Panel on the mortality/safety signal concerns following PAD intervention with devices delivering paclitaxel. Pathways is intended to leverage the immediate challenges of questions surrounding the paclitaxel mortality signal discernment as a use case promoting improvements to the evaluation of all PAD devices throughout their lifecycle. RAPID Pathways will provide a neutral ground to foster frank dialogue among stakeholders already engaged in these issues, and to promote pragmatic, collaborative, pre-competitive approaches with well-defined deliverables and timelines serving these objectives.
Pathways is structured to combine leadership from regulatory, industry, clinical and professional society stakeholders in multiple areas of key expertise, including clinical data content, clinical data structure, biostatistics, patient preference science, as well as to host currently active studies examining data from industry, professional societies, claims, third party payers, the VA Medical Centers, and international sources.
Pathways will develop a ‘lean’ case report form and explore other opportunities to support future device trials using lessons learned from the PTX experience. RAPID Pathways will focus on the goal of “better, faster, cheaper” PAD device evaluation.
Phase I WG Chairs
Schuyler Jones, MD, DCRI (Clinical)
James Tcheng, MD, DCRI (Informatics)
Terrie Reed, FDA (GUDID)
Phase I WG Informaticists
Anne Heath, DCRI
Mary Williams, DCRI
- RAPID Phase I Deliverables Summary Document
- RAPID Use Cases
- RAPID Work Flow
- RAPID Core Data Elements
- GUDID Integration Workgroup Project Summary
Click on the plus sign (+) to view additional information.
RAPID Phase II Goals & Aims:
- Implement the RAPID core data set (clinical and GUDID data elements) in a variety of healthcare information systems to advance the collection and exchange of interoperable electronic health data;
- Represent the RAPID core data elements (CDEs) in interoperable, standards-based models (LOINC, SNOMED, HL7);
- Describe a minimal set of common domain variables (general patient identifiers & common clinical data elements) needed to aggregate data sets from multiple sources;
- Develop a core set of unique device attributes (AUDI) to complement the RAPID core data set and common domain variables to support PAD studies;
- Assess & evaluate quality of data in the AccessGUDID database for devices used to treat peripheral vascular disease;
- Develop projects to demonstrate extraction & use of patient-level data for the RAPID core data elements to support regulatory applications;
- Assess and evaluate data governance, sharing, access and publication guidelines of RAPID data partners
Click here for a summary of SPEED.
RAPID Phase II Working Groups
3 Major U.S. Societies / Registries
American College of Cardiology (ACC)
- National Cardiovascular Disease Registry (NCDR)
Society of Interventional Radiology (SIR)
- National Interventional Radiology Quality Registry (NIRQR)
Society for Vascular Surgery (SVS)
- Vascular Quality Initiative (VQI)
7 U.S. Federal Agencies
- FDA (CDRH pre- and post-market, and CEDR)
- Agency for Healthcare Research and Quality (AHRQ)
- Centers for Medicare and Medicaid Services (CMS)
- Department of Defense (DOD) Healthcare Resources
- Office of the National Coordinator (ONC)
- National Heart, Lung and Blood Institute (NHLBI)
- National Library of Medicine (NLM)
12 Peripheral Vascular Device Manufacturers
- Aortic Medical Inc.
- Bard Peripheral Vascular
- Boston Scientific
- Cardiovascular Systems Inc.
- Cook Medical
16 Related Companies / Organizations
- Association for Healthcare Resource & Materials Management (AHRMM)
- Boston Biomedical Assoc.
- Cognitive Medical Systems
- Deloite Healthcare
- Device Events
- First Database, Inc.
- Global Healthcare Exchange
- Healthjump Inc.
- Novella Clinical, Quintiles
- UltaMed Corp. INC Research
NESTcc identifies and selects key demonstration projects to provide proof of concept for scalable approaches to evidence generation across device types and across the total product life cycle. Early NESTcc Demonstration Projects are studies that contribute to the field of Real-World Evidence (RWE) within the medical device ecosystem. These projects range in size and scope but will:
- Develop, verify, and operationalize methods of evidence generation and data use in the pre- and post-market space
- Demonstrate scalability across healthcare systems, device types, and manufacturers
- Demonstrate impact on patients by stimulating innovation in medical device innovation and decreasing the timeline for development and market launch
- Inform NEST’s strategy as it builds out critical functions and processes for a future sustainable organization
Malone, M. (2018). SPEED: A New Initiative in Real-World PAD Evidence Evaluation. An overview of the FDA’s new multistakeholder project to support real-world evidence evaluation for devices aimed at treating peripheral artery disease. Endovascular Today 17.9 (2018): 57-60.
Shuren, J., & Califf, R. M. (2016). Need for a National Evaluation System for Health Technology. Jama. doi:10.1001/jama.2016.8708
Morales, J.P., Cronenwett, J, Thatcher, R. (2016). Registry Assessment of Peripheral Interventional Devices (RAPID). Endovascular Today 15.8 (2016): 85-94.
Jones W.S., Krucoff M.W., Morales P., Wilgus R.W., Heath A.H., Williams M.F., Tcheng J.E., Marinac-Dabic J.D., Malone M.L., Reed T.L., Fukaya R., Lookstein R.A., Handa N., Aronow H.D., Bertges D.J., Jaff M.R., Tsai T.T., Smale J.A., Zaugg M.J., Thatcher R.J., Cronenwett J.L. Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements. (2018). NCBI PMID:29389426
W. Jones-Mitchell Krucoff-Pablo Morales Registry Assessment of Peripheral Interventional Devices (RAPID)― Registry Assessment of Peripheral Interventional Devices Core Data Elements. (2018). Journal of Vascular Surgery,82(2), 316-322.
The following Learning UDI Community work groups are active:
- Catalog Number Fields: This work group will focus on the importance of catalog numbers in GUDID information.
- Clinically Relevant Size: This work group will discuss how to make the GUDID more useful and what device size types and Units of measure to capture.
- Search Criteria for High Risk Implants: This work group is being charged with developing a more user-based set of search criteria that would be run against AccessGUDID and return a search result to document implants in health IT— including those working with the automated billing process—and to be shared publicly.
- Device Categorization: GMDN/SNOMED Terminologies: This work group should review the pros and cons of GMDN and SNOMED terminologies and review findings of preliminary pilot exercises (RAPID), while also recognizing that additional vocabularies for medical devices, such as UMDNS, UNSPSC, or others, may provide value to GUDID device data and NEST priorities.
- Medical Devices Containing Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P): The work group will focus on the tracking of medical devices containing HCT/P through the entire supply chain and will engage participants from all parts of that chain to develop educational material and guidance to address the issues described in the summary.
- UDI Benefits to Healthcare Supply Chain Processes: This work group will develop five important workflow processes as they currently work without UDI and then contrast these to future workflows where UDI is incorporated in hospital information systems and operations.
- UDI Capture: The ultimate goal of this work group is to identify opportunities for case studies, initiate them, and bring answers to the greater Learning UDI Community to foster learning and hopefully, shorten the adoption curve for capturing UDI’s within healthcare.
- UDI Single Use Device (SUD) Packaging Exception and Distributor Low Unit of Measure Programs: The work group will explore cost effective and sustainable solutions around labeling at the lowest unit of measure/unit of use—where technically feasible—devices that meet the UDI final rule’s SUD packaging exception.
- *Unit of Use: This is an “unmarked” or “virtual” Device Identifier (DI); assigned to an individual medical device when a UDI is not labeled on the individual device at the level of its unit of use. This is usually applicable to situations when the Device Count in the base package is >1. This work group is working to identify legitimate UoU cases where a UoU UDI is applicable (i.e., products/situations where you would absolutely need a DI for each widget within the lowest package level). These examples will help assist in a potential solution rather than requiring a UoU UDI for all products with multiple widgets/eaches.
*denotes the group is full, and no longer accepting new participants.
The mission of the Augmented UDI (AUDI) workgroup is to provide the framework for expanding the FDA GUDID system to manage additional data about medical devices.
The Interoperability Proving Ground (IPG) is an open, community platform where you can share, learn, and be inspired by interoperability projects occurring in the United States (and around the world).
Supported by the Common Fund at the National Institutes of Health (NIH), the NIH Health Care Systems Research Collaboratory aims to improve the way clinical trials are conducted by creating a new infrastructure for collaborative research with healthcare systems. The ultimate goal is to ensure that healthcare providers and patients can make decisions based on the best available clinical evidence.
PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct comparative clinical effectiveness research efficiently by creating a large, highly representative network for conducting clinical outcomes research that directly involves patients in the development and execution of the research.
Sentinel is the FDA’s national electronic system which has transformed the way researchers monitor the safety of FDA-regulated medical products, including drugs, vaccines, biologics, and medical devices.
The MDEpiNet BUILD Initiative encompasses efforts to demonstrate, implement, and apply unique device identification (UDI) in health care. The initiative focuses on implantable devices, leveraging UDI to connect data sources, to access the global unique device identification database (GUDID), to move information on devices to clinicians for patient care, to allow researchers to assess device effectiveness and safety, and to support device innovation across the device product life cycle.
The Healthcare Services Platform Consortium (HSPC) is a provider-driven organization of leading healthcare organizations, IT vendors, systems integrators, and venture firms dedicated to unlocking the power of entrepreneurial innovation to improve healthcare outcomes. The mission of HSPC is to improve health by creating a vibrant, open ecosystem of interoperable applications, knowledge, content, and services.
Better Evidence on Medical Devices: A Coordinating Center for a 21st Century National Medical Device Evaluation System.
The Duke-Margolis Center brings together capabilities that generate and analyze evidence across the spectrum of policy to practice, supporting the triple aim of health care – improving the experience of care, the health of populations and reducing the per capita cost.
The Clinical Information Modeling Initiative (CIMI) is an international collaboration dedicated to providing a common format for detailed specifications for the representation of health information content. In this way semantically interoperable information may be created and shared in health records, messages, and documents. The mission of the CIMI is to improve the interoperability of healthcare systems through shared implementable clinical information models.
Pew’s medical device initiative seeks to enhance medical device safety and foster device innovation that benefits patients. Pew’s initiative has three main areas of focus, including:
- Improving the current state of medical device registries—databases containing information on patients who use or are treated with a specific device;
- Supporting the adoption of a unique device identification (UDI) system to better track medical devices; and
- Fostering medical device innovation with these and other new approaches without compromising patient safety.
The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI).
The data standards covered in this document are divided into 6 distinct tables. The first table covers general data elements common to all PAVDs, including demographic information, atherosclerotic risk factors, concurrent atherosclerotic diseases, comorbid conditions, medications, the cardiovascular examination, and relevant blood chemistries and hematology. The remaining tables cover data standards specific for lower extremity PAD, AAA, renal artery disease, mesenteric artery disease, and extracranial carotid and vertebral artery disease, respectively. Each of the disease-specific tables includes the following data elements: medical history, physical examination, laboratory testing, diagnostic procedures, invasive therapeutic procedures (both endovascular and open surgical), pharmacological therapy, follow-up, and outcomes.
Evaluation and Treatment of Patients With Lower Extremity Peripheral Artery Disease. Consensus Definitions From Peripheral Academic Research Consortium (PARC). The PARC, together with the U.S. Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, has developed a series of pragmatic consensus definitions for patients being treated for peripheral artery disease affecting the lower extremities. These consensus definitions include the clinical presentation, anatomic depiction, interventional outcomes, surrogate imaging and physiological follow-up, and clinical outcomes of patients with lower-extremity peripheral artery disease. Consistent application of these definitions in clinical trials evaluating novel revascularization technologies should result in more efficient regulatory evaluation and best practice guidelines to inform clinical decisions in patients with lower extremity peripheral artery disease.
The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization. It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization and convergence.
The Society for Vascular Surgery® (SVS) is a not-for-profit professional medical society, composed primarily of vascular surgeons, that seeks to advance excellence and innovation in vascular health through education, advocacy, research and public awareness.
The Vascular Quality Initiative (VQI) is a collaborative of regional quality groups collecting and analyzing data in an effort to improve patient care. The VQI collects perioperative and one-year follow-up data to generate real-time benchmarked reports to assess quality of care and determine best practices in vascular surgery.
The Society of Interventional Radiology is a national organization of physicians, scientists, and allied health professionals dedicated to improving public health through disease management and minimally invasive, image-guided therapeutic interventions.