RAPID - Overview
RAPID provides a forum for collaborations between experts from regulatory, industry, clinical and professional societies with multiple areas of key expertise, including clinical data content, clinical data structure, biostatistics, patient preference science. Together, they partner to improve data, practices, methods used to evaluate devices used to manage for peripheral vascular intervention. Likewise RAPID partners collaborate through clinical research activities to advance science and improve health care for people with peripheral arterial disease.
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 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.
RAPID Phase IV Registry-Supported Prospective Trials to Support Regulatory Decisions
The objectives this Phase include deliverables supporting both higher quality evidence accrual and efficiencies reducing redundant work, costs and study timelines supporting “better, faster, cheaper” prospective randomized and single arm trials. The pandemic impact on cardiovascular medical device research further unmasked the need for more resilient prospective clinical trial designs that can enroll patients and execute protocol-driven care with follow up collecting fit-to-purpose outcomes even in the setting of extensive environmental uncertainties.