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Article History

Received: 15 February 2024

Accepted: 3 September 2024

First Online: 18 September 2024

Declarations

:

: Institutional Review Board approval was obtained at Yale University and University of Florida. The informed consent was waived by ethics committee at Yale University and University of Florida considering the retrospective nature of the study.

: Not applicable.

: Yuan Lu received support from the Sentara Research Foundation, the National Heart, Lung, and Blood Institute of the National Institutes of Health (under awards R01HL69954 and R01HL169171), and the Patient-Centered Outcomes Research Institute (under award HM-2022C2-28354) outside of the submitted work. Sanket S. Dhruva receives research funding from the National Evaluation System for health Technology Coordinating Center (NESTcc), The Greenwall Foundation, Arnold Ventures and the National Institute for Health Care Management (NIHCM). In the past 36 months, He has also received funding from the Food and Drug Administration and the National Heart, Lung, and Blood Institute of the National Institutes of Health (K12HL138046). Dr. Dhruva also reports serving on the Institute for Clinical and Economic Review (ICER) California Technology Assessment Forum. Wade Schulz collaborates with the National Center for Cardiovascular Diseases in Beijing, is a technical consultant to HugoHealth, a personal health information platform, and co-founder of Refactor Health, an AI-augmented data management platform for healthcare, as well as a consultant for Interpace Diagnostics Group, a molecular diagnostics company. In the past three years, Harlan Krumholz has received options for Element Science and Identifeye and payments from F-Prime for advisory roles. He is a co-founder of and holds equity in Hugo Health, Refactor Health, and ENSIGHT-AI. He is associated with research contracts through Yale University from Janssen, Kenvue, Novartis, and Pfizer. Joseph S. Ross currently receives research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium (MDIC) as part of NEST, from the FDA for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), from the NHLBI of the NIH (R01HS025164, R01HL144644) and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International; in addition, Dr. Ross is an expert witness at the request of Relator's attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. Eric Barrette, Jenny Gaffney, and Bonnie Handke are employees of Medtronic, Inc. All other coauthors have no conflict of interests.