Use of data from the Vascular Quality Initiative registry to support regulatory decisions yielded a high return on investment
Background Real-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 hav...
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doaj-03c129d74dcc4565a102ab0c21fb89952021-01-22T05:00:09ZengBMJ Publishing GroupBMJ Surgery, Interventions, & Health Technologies2631-49402020-11-012110.1136/bmjsit-2020-000039Use of data from the Vascular Quality Initiative registry to support regulatory decisions yielded a high return on investmentArt Sedrakyan0Gregory Pappas1Erika Avila-Tang2Danica Marinac-Dabic3Jack L Cronenwett4Adam W Beck5Daniel Bertges6Jens Eldrup-Jorgensen7Frederic S Resnic8Nadezda Radoja9Andreas Schick10Josh Smale11Roberta A Bloss12Peter Phillips13Melissa Hasenbank14Shengchun Wang15Healthcare Polcy and Research, Weill Cornell Medical College, New York, New York, USACenter for Biologics Evaluation and Research, Food and Drug Administration Office of the Commissioner, Rockville, Maryland, USACenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, USACenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, USADepartment of Surgery, Dartmouth College Geisel School of Medicine, Hanover, New Hampshire, USADepartment of Surgery, The University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USADepartment of Surgery, University of Vermont College of Medicine, Burlington, Vermont, USADepartment of Surgery, Maine Medical Center, Portland, Maine, USADepartment of Cardiology, Lahey Hospital and Medical Center, Burlington, Massachusetts, USACenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, USACenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, USAB-D Bard, Franklin Lakes, New Jersey, USAW L Gore and Associates Medical Products Division, Flagstaff, Arizona, USALombard Medical Ltd, Didcot, UKMedtronic Inc, Minneapolis, Minnesota, USAMedtronic Inc, Minneapolis, Minnesota, USABackground Real-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.Objectives To determine the potential value (cost and time saving and return on investment) created by device evaluation studies using the VQI registry infrastructure.Methods We 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.Results We 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.Conclusions The 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.https://sit.bmj.com/content/2/1/e000039.full |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Art Sedrakyan Gregory Pappas Erika Avila-Tang Danica Marinac-Dabic Jack L Cronenwett Adam W Beck Daniel Bertges Jens Eldrup-Jorgensen Frederic S Resnic Nadezda Radoja Andreas Schick Josh Smale Roberta A Bloss Peter Phillips Melissa Hasenbank Shengchun Wang |
spellingShingle |
Art Sedrakyan Gregory Pappas Erika Avila-Tang Danica Marinac-Dabic Jack L Cronenwett Adam W Beck Daniel Bertges Jens Eldrup-Jorgensen Frederic S Resnic Nadezda Radoja Andreas Schick Josh Smale Roberta A Bloss Peter Phillips Melissa Hasenbank Shengchun Wang Use of data from the Vascular Quality Initiative registry to support regulatory decisions yielded a high return on investment BMJ Surgery, Interventions, & Health Technologies |
author_facet |
Art Sedrakyan Gregory Pappas Erika Avila-Tang Danica Marinac-Dabic Jack L Cronenwett Adam W Beck Daniel Bertges Jens Eldrup-Jorgensen Frederic S Resnic Nadezda Radoja Andreas Schick Josh Smale Roberta A Bloss Peter Phillips Melissa Hasenbank Shengchun Wang |
author_sort |
Art Sedrakyan |
title |
Use of data from the Vascular Quality Initiative registry to support regulatory decisions yielded a high return on investment |
title_short |
Use of data from the Vascular Quality Initiative registry to support regulatory decisions yielded a high return on investment |
title_full |
Use of data from the Vascular Quality Initiative registry to support regulatory decisions yielded a high return on investment |
title_fullStr |
Use of data from the Vascular Quality Initiative registry to support regulatory decisions yielded a high return on investment |
title_full_unstemmed |
Use of data from the Vascular Quality Initiative registry to support regulatory decisions yielded a high return on investment |
title_sort |
use of data from the vascular quality initiative registry to support regulatory decisions yielded a high return on investment |
publisher |
BMJ Publishing Group |
series |
BMJ Surgery, Interventions, & Health Technologies |
issn |
2631-4940 |
publishDate |
2020-11-01 |
description |
Background Real-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.Objectives To determine the potential value (cost and time saving and return on investment) created by device evaluation studies using the VQI registry infrastructure.Methods We 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.Results We 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.Conclusions The 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. |
url |
https://sit.bmj.com/content/2/1/e000039.full |
work_keys_str_mv |
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