Document is current

Article History

Received: 19 March 2024

Accepted: 13 August 2024

First Online: 28 August 2024

Declarations

:

: We did not involve members of the public or patients when we designed our study, interpreted the results, or wrote the manuscript. However, we asked members of the public to read our manuscript after submission to ensure it was understandable. The study did not require institutional review board approval because it was based on publicly available information, in accordance with 45 CFR § 46. Informed consent was not needed because no patient data were used. This cross-sectional study adheres to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline.

: Not applicable.

: Mr Janda reported receiving grants from the Yale Center for Excellence in Regulatory Science and Innovation Scholars Program and Yale Center of Clinical Investigation during the conduct of the study. Dr Jeffery reported grants from the Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute; the National Institute on Drug Abuse; the Centers for Disease Control and Prevention; the National Center for Advancing Translational Sciences; and the US Food and Drug Administration outside the submitted work. Dr. Ramachandran reported receiving consultancy fees from ReAct Action on Antibiotic Resistance Strategic Policy Program, grants from the Stavros Niarchos Foundation for a project on public research and development, and grants from the FDA for a research project on representation within clinical trials for oncology therapeutics outside of the submitted work. Dr. Ross reported receiving grants from the FDA, Johnson & Johnson, Medical Devices Innovation Consortium, Agency for Healthcare Research and Quality, and National Heart, Lung, and Blood Institute; and having been an expert witness at the request of realtor’s attorney, the Greene Law Firm, in a qui tam lawsuit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc that was Settled in September 2022. Dr. Wallach reported receiving grants from Johnson & Johnson (through the Yale Open Data Access Project) and the FDA, as well as consulting fees from Hagen Berman Sobol Shapiro LLP and Dugan Law Firm APLC outside the submitted work.