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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/26459

Title: Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium
Authors: Seltzer, Jonathan H.
Heise, Ted
Carson, Peter
Canos, Daniel
Hiatt, Jo Carol
Vranckx, Pascal
Christen, Thomas
Cutlip, Donald E.
Issue Date: 2017
Citation: AMERICAN HEART JOURNAL, 190, p. 76-85
Abstract: This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled "The Role of Endpoint Adjudication in Medical Device Clinical Trials". The think tank was cosponsored by the Cardiac Safety Research Committee, MDEpiNet and the US Food and Drug Administration (FDA) and was convened at the FDA's White Oak headquarters on March 11, 2016. Attention was focused on tailoring best practices for evaluation of endpoints in medical device clinical trials, practical issues in endpoint adjudication of therapeutic, diagnostic, biomarker and drug-device combinations, and the role of adjudication in regulatory and reimbursement issues throughout the device lifecycle. Attendees included representatives from medical device companies, the FDA, Centers for Medicare and Medicaid Services (CMS), end point adjudication specialist groups, clinical research organizations, and active, academically based adjudicators. The manuscript presents recommendations from the think tank regarding (1) rationale for when adjudication is appropriate, (2) best practices establishment and operation of a medical device adjudication committee and (3) the role of endpoint adjudication for post market evaluation in the emerging era of real world evidence.
URI: http://hdl.handle.net/1942/26459
DOI: 10.1016/j.ahj.2017.05.009
ISI #: 000407410800010
ISSN: 0002-8703
Category: A1
Type: Journal Contribution
Appears in Collections: Research publications

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