Assessing Patient Risk, Benefit, and Outcomes in Drug Development: A Decade of Lenvatinib Clinical Trials: A Systematic Review

Funding

No external funding was used in the preparation of this manuscript.

Conflicts of Interest/Competing Interests

Vinay Prasad reports research funding from Arnold Ventures; royalties from Johns Hopkins Press, Medscape, and MedPage; honoraria from GrandRounds/lectures from universities, medical centers, non-profits, professional societies, YouTube, and Substack; consulting from UnitedHealthcare and OptumRX; and speaking fees from Evicore. Plenary Session podcast has Patreon backers. Matt Vassar reports receipt of funding from the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, the US Office of Research Integrity, Oklahoma Center for Advancement of Science and Technology, and internal grants from Oklahoma State University Center for Health Sciences, all outside of the present work. Patrick Crotty, Karim Kari, Griffin K. Hughes, Chase Ladd, Ryan McIntire, Brooke Gardner, Andriana M. Peña, Sydney Ferrell, Jordan Tuia, Jacob Cohn, and Alyson Haslam declare that they have no conflicts of interest that might be relevant to the contents of this manuscript.

Ethics Approval

The OSU-CHS Institutional Review Board (IRB) has determined that this project does not qualify as human subject research as defined in 45 CFR 46.102(d) and (f) and is not subject to further oversight by the OSU-CHS IRB.

Data Availability

The datasets generated and/or analyzed during the current study are available in the OSF repository (https://osf.io/vdr68/?view_only=78fb8b6f2e3e440aa71423b40ec8dd46).

Author Contributions

The work reported in the paper has been performed by the authors, unless clearly specified in the text. Each of the author’s contributions have been reported in accordance with CRediT: PC: Conceptualization, data curation, formal analysis, investigation, methodology, project administration, resources, software, supervision, validation, visualization, writing - original draft, writing - review & editing KK: conceptualization, data curation, formal analysis, investigation, methodology, project administration, resources, software, supervision, validation, visualization, writing - original draft, writing - review & editing GH: conceptualization, data curation, formal analysis, investigation, methodology, project administration, resources, software, supervision, validation, visualization, writing - original draft, writing - review & editing CL: conceptualization, data curation, formal analysis, investigation, methodology, project administration, resources, software, supervision, validation, visualization, writing - original draft, writing - review & editing RM: data curation, investigation, methodology, project administration, supervision, validation, writing - original draft BG: data curation, investigation, methodology, project administration, supervision, validation, writing - original draft AP: data curation, investigation, methodology, project administration, supervision, validation, writing - original draft SF: data curation, resources, software, methodology JT: data curation, resources, software, visualizatio JC: data curation, resources, software, methodology AH: conceptualization, formal analysis, methodology, project administration, resources, validation, supervision, writing - review & editing VP: conceptualization, formal analysis, investigation, methodology, project administration, resources, supervision, validation, writing - original draft, writing - review & editing MV: conceptualization, investigation, methodology, project administration, resources, supervision, validation, writing - original draft, writing - review & editing

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