Use of data from the Vascular Quality Initiative registry to support regulatory decisions yielded a high return on investment

Abstract

BackgroundReal-world data (RWD) from the Society for Vascular Surgery Vascular Quality Initiative (VQI) registry has been used to support US Food and Drug Administration (FDA) regulatory decisions regarding vascular devices. The variables of cost and time needed for these registry-based studies have not been previously compared to traditional, independent, industry studies that would otherwise have been conducted to support regulatory decisions.ObjectivesTo determine the potential value (cost and time saving and return on investment) created by device evaluation studies using the VQI registry infrastructure.MethodsWe compared studies that used data from the VQI registry with estimated costs of independent industry studies (counterfactual studies) using an established model using design specifications determined by FDA reviewers.ResultsWe analyzed the initial six studies evaluating vascular devices for regulatory decisions using data from the VQI registry that generated evidence for four device manufacturers. Return on investment for these studies was estimated to be 143% and cost saving as 59% based on an actual per patient (with 5-year follow-up) cost of US$11K using VQI data versus US$26K from the counterfactual when averaged across all studies. Significant enrollment time savings (45%–71%) were also realized compared with industry-based estimates.ConclusionsThe use of RWD from the VQI registry in this study and the transcatheter valve treatment coordinated registry network in a prior study indicates that substantial value was added to device evaluation projects by the reuse of registry data, with additional potential savings if linked claims data can be used instead of costly long-term in-person follow-up.

Endovascular versus open repair in patients with abdominal aortic aneurysm: a claims-based data analysis in Japan

“…In other words, most of the resource for a post-marketing surveillance system with the highest sensitivity is not aimed at the highest risk patient population. Therefore, regulators, manufacturers, and academia need to optimize the allocation of resources to create a real-world surveillance system9 to collect long-term follow-up data for quality improvement 34–36…”

“…Therefore, regulators, manufacturers, and academia need to optimize the allocation of resources to create a real-world surveillance system 9 to collect long-term follow-up data for quality improvement. [34][35][36] There are opportunities for international collaborations to improve the quality of care. 37 Codes and algorithms from previous claims-based studies helped identify an unmet medical need in Japan, that is, the need to create a real-world surveillance system for the long-term follow-up of EVAR in rAAA.…”

Das Qualitätssicherungs- und Deviceregister des Deutschen Instituts für Gefäßmedizinische Gesundheitsforschung der DGG im Zeitalter von COVID-19, Big Data und künstlicher Intelligenz

“…Darüber hinaus ist die Gründung und Unterhaltung von regionalen Qualitätsgruppen geplant, die Zugriff auf anonymisierte Registerdaten erhalten, um Aufgaben der Versorgungsforschung und Qualitätssicherung wahrzunehmen. Damit folgt das Vorhaben in weiten Teilen den seit Jahrzehnten etablierten Aspekten der Vascular Quality Initiative (VQI) der amerikanischen Gesellschaft für Gefäßchirurgie [ 22 , 23 ].…”

Postmarket surveillance of high-risk medical devices needs transparent, comprehensive and independent registries

“…That has been reinforced by simulation-specific extensions to the Strengthening the Reporting of Observational Studies in Epidemiology recommendations for reporting observational research 3 and by the Consolidated Health Economic Evaluation Reporting Standards guidance on reporting economic evaluations in healthcare. 4 Aspects of both statements are relevant to the paper by Cronenwett et al 5 in this issue of BMJ Surgery, Interventions, & Health Technologies .…”

“…The largest component of the actual costs of the registry studies was the charge per patient to manufacturers for access to the VQI data. 5 The investigators have stated that this charge to industry is market driven, based on value and not relatable to specific costs. It includes payments to participating centres for entering additional data, and to the subcontractor responsible for monitoring data.…”