Determining value of Coordinated Registry Networks (CRNs): a case of transcatheter valve therapies
Year: 2019
Type: article
Abstract: 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.
Authors: 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, Michael Mack, Fred Masoudi, Danica Marinac-Dabic, Roxanna Mehran, Sharon-Lise Normand, Elizabeth Quin, Fred Resnic, Art Sedrakyan, Ronald Waksman, Larry Wood, Changfu Wu, Tianay Ziegler
Institutions: United States Food and Drug Administration, Johnson & Johnson (United States), University of Colorado Denver, Mercy Health, American College of Cardiology, NewYork–Presbyterian Hospital, Columbia University Irving Medical Center, Cardiovascular Research Foundation, Columbia University, Duke Clinical Research Institute, Baylor Scott & White Health, Harvard University, Tufts University, Lahey Hospital and Medical Center, Weill Cornell Medicine, Princeton University
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,800
OpenAlex ID: W2953482944