Determining value of Coordinated Registry Networks (CRNs): a case of transcatheter valve therapies
Background The Transcatheter Valve Therapy (TVT) Coordinated Registry Network (CRN) supported 23 regulatory decisions and ensured evidence-based evaluation of the application of TVT technology. However, there are cost concerns that require value assessment of the TVT CRN compared with traditional st...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2019-07-01
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| Series: | BMJ Surgery, Interventions, & Health Technologies |
| Online Access: | https://sit.bmj.com/content/1/1/e000003.full |
| _version_ | 1826968573995646976 |
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| author | Michael Mack Art Sedrakyan Gregory Pappas Jesse Berlin Erika Avila-Tang John Carroll Joseph Drozda Douglas Dumont Thomas Gross Kathleen Hewitt Ajay Kirtane David Kong Mitchell Krucoff John Lashinger Nellie Lew Fred Masoudi Danica Marinac-Dabic Roxanna Mehran Sharon-Lise Normand Elizabeth Quin Fred Resnic Ronald Waksman Larry Wood Changfu Wu Tianay Ziegler |
| author_facet | Michael Mack Art Sedrakyan Gregory Pappas Jesse Berlin Erika Avila-Tang John Carroll Joseph Drozda Douglas Dumont Thomas Gross Kathleen Hewitt Ajay Kirtane David Kong Mitchell Krucoff John Lashinger Nellie Lew Fred Masoudi Danica Marinac-Dabic Roxanna Mehran Sharon-Lise Normand Elizabeth Quin Fred Resnic Ronald Waksman Larry Wood Changfu Wu Tianay Ziegler |
| author_sort | Michael Mack |
| collection | DOAJ |
| description | Background The Transcatheter Valve Therapy (TVT) Coordinated Registry Network (CRN) supported 23 regulatory decisions and ensured evidence-based evaluation of the application of TVT technology. However, there are cost concerns that require value assessment of the TVT CRN compared with traditional study designs.Objectives We aimed to determine the value created by the TVT CRN based on (1) Return on investment (ROI), (2) Time saved (TS) in conducting necessary regulatory studies.Methods For both ROI and TS analyses, we compared studies that used the TVT CRN with those that would have been required if the registry did not exist (counterfactual studies). To estimate ROI, we accounted for the costs of investment and gain from investment. Both the counterfactual costs and length of studies were projected using design specifications determined by US Food and Drug Administration (FDA) reviewers.Results We identified 21 studies using the TVT CRN (supporting 23 FDA decisions) that generated evidence on TVT for three device manufacturers. ROI is estimated to be greater than 550%. TS by using the CRN ranged from months to years.Conclusions The CRN method to evidence generation creates value for manufacturers and the broader device ecosystem, demonstrated with this example of the TVT CRN. The public health benefits of evidence created by this CRN outweighs the difference in data quality between traditional clinical studies and the CRN method. |
| first_indexed | 2024-04-24T11:29:52Z |
| format | Article |
| id | doaj.art-6c16e90fc9544574998a6df257247be3 |
| institution | Directory Open Access Journal |
| issn | 2631-4940 |
| language | English |
| last_indexed | 2025-02-18T04:13:23Z |
| publishDate | 2019-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Surgery, Interventions, & Health Technologies |
| spelling | doaj.art-6c16e90fc9544574998a6df257247be32024-11-20T12:30:08ZengBMJ Publishing GroupBMJ Surgery, Interventions, & Health Technologies2631-49402019-07-011110.1136/bmjsit-2019-000003Determining value of Coordinated Registry Networks (CRNs): a case of transcatheter valve therapiesMichael Mack0Art Sedrakyan1Gregory Pappas2Jesse Berlin3Erika Avila-Tang4John Carroll5Joseph Drozda6Douglas Dumont7Thomas Gross8Kathleen Hewitt9Ajay Kirtane10David Kong11Mitchell Krucoff12John Lashinger13Nellie Lew14Fred Masoudi15Danica Marinac-Dabic16Roxanna Mehran17Sharon-Lise Normand18Elizabeth Quin19Fred Resnic20Ronald Waksman21Larry Wood22Changfu Wu23Tianay Ziegler24Baylor Scott & White Health, Dallas, Texas, USAPopulation Health Sciences, Joan and Sanford I Weill Medical College of Cornell University, New York, New York, USACenter for Biologics Evaluation and Research, Food and Drug Administration Office of the Commissioner, Rockville, Maryland, USAPharmacoepidemiology, Johnson and Johnson Services Inc, New Brunswick, New Jersey, USACenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, USAInterventional Cardiology, University of Colorado Denver, Denver, Colorado, USAMercy Health, Chesterfield, Missouri, USAFood and Drug Administration, Department of Health and Human Services, Silver Spring, Maryland, USAFood and Drug Administration, Department of Health and Human Services, Silver Spring, Maryland, USANational Cardiovascular Data Registry, American College of Cardiology, Washington DC, United StatesCardiovascular Research Foundation, Columbia University / New York-Presbyterian Hospital, New York City, New York, USADuke Clinical Research Institute, Durham, North Carolina, USADuke Clinical Research Institute, Durham, North Carolina, USAFood and Drug Administration, Department of Health and Human Services, Silver Spring, Maryland, USAFood and Drug Administration, Department of Health and Human Services, Silver Spring, Maryland, USAInterventional Cardiology, University of Colorado Denver, Denver, Colorado, USACenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, USACardiovascular Research Foundation, Columbia University / New York-Presbyterian Hospital, New York City, New York, USADepartment of Biostatistics, Harvard School of Public Health, Cambridge, Boston, United StatesFood and Drug Administration, Department of Health and Human Services, Silver Spring, Maryland, USADivision of Cardiovascular Medicine, Lahey Hospital and Medical Center and Tufts University School of Medicine, Boston, Massachusetts, USAAmerican College of Cardiology, Washington, District of Columbia, USAAmerican College of Cardiology, Washington, District of Columbia, USAFood and Drug Administration, Department of Health and Human Services, Silver Spring, Maryland, USAPrinceton University, Princeton, New Jersey, USABackground The Transcatheter Valve Therapy (TVT) Coordinated Registry Network (CRN) supported 23 regulatory decisions and ensured evidence-based evaluation of the application of TVT technology. However, there are cost concerns that require value assessment of the TVT CRN compared with traditional study designs.Objectives We aimed to determine the value created by the TVT CRN based on (1) Return on investment (ROI), (2) Time saved (TS) in conducting necessary regulatory studies.Methods For both ROI and TS analyses, we compared studies that used the TVT CRN with those that would have been required if the registry did not exist (counterfactual studies). To estimate ROI, we accounted for the costs of investment and gain from investment. Both the counterfactual costs and length of studies were projected using design specifications determined by US Food and Drug Administration (FDA) reviewers.Results We identified 21 studies using the TVT CRN (supporting 23 FDA decisions) that generated evidence on TVT for three device manufacturers. ROI is estimated to be greater than 550%. TS by using the CRN ranged from months to years.Conclusions The CRN method to evidence generation creates value for manufacturers and the broader device ecosystem, demonstrated with this example of the TVT CRN. The public health benefits of evidence created by this CRN outweighs the difference in data quality between traditional clinical studies and the CRN method.https://sit.bmj.com/content/1/1/e000003.full |
| spellingShingle | Michael Mack Art Sedrakyan Gregory Pappas Jesse Berlin Erika Avila-Tang John Carroll Joseph Drozda Douglas Dumont Thomas Gross Kathleen Hewitt Ajay Kirtane David Kong Mitchell Krucoff John Lashinger Nellie Lew Fred Masoudi Danica Marinac-Dabic Roxanna Mehran Sharon-Lise Normand Elizabeth Quin Fred Resnic Ronald Waksman Larry Wood Changfu Wu Tianay Ziegler Determining value of Coordinated Registry Networks (CRNs): a case of transcatheter valve therapies BMJ Surgery, Interventions, & Health Technologies |
| title | Determining value of Coordinated Registry Networks (CRNs): a case of transcatheter valve therapies |
| title_full | Determining value of Coordinated Registry Networks (CRNs): a case of transcatheter valve therapies |
| title_fullStr | Determining value of Coordinated Registry Networks (CRNs): a case of transcatheter valve therapies |
| title_full_unstemmed | Determining value of Coordinated Registry Networks (CRNs): a case of transcatheter valve therapies |
| title_short | Determining value of Coordinated Registry Networks (CRNs): a case of transcatheter valve therapies |
| title_sort | determining value of coordinated registry networks crns a case of transcatheter valve therapies |
| url | https://sit.bmj.com/content/1/1/e000003.full |
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