Racial Diversity and Reporting in United States Food and Drug Administration Registration Trials for Thoracic Malignancies from 2006 to 2020

Ryan S. Chianga Department of Medicine, Stanford University, Stanford, CA, USACorrespondence[email protected]

https://orcid.org/0000-0003-2277-857X

Aakash Desaib Division of Oncology, Department of Medicine, Mayo Clinic, Rochester, MN, USA

Michael J. Glovera Department of Medicine, Stanford University, Stanford, CA, USA

Gavin Huia Department of Medicine, Stanford University, Stanford, CA, USA

Kavitha J. Ramchandranc Division of Oncology, Department of Medicine, Stanford University, Stanford, CA, USA

Heather Wakeleec Division of Oncology, Department of Medicine, Stanford University, Stanford, CA, USA

Mark P. Lythgoed Imperial College London, London, UK

Ali Raza Khakic Division of Oncology, Department of Medicine, Stanford University, Stanford, CA, USACorrespondence[email protected]

https://orcid.org/0000-0002-4655-4426

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Abstract

There is significant racial disparity in thoracic malignancies in terms of epidemiology and outcomes. We analyzed race reporting and racial diversity in the registration trials of drugs approved by the FDA for thoracic malignancies from 2006 to 2020. We found a significant under-representation of non-white participants in FDA drug registration trials in thoracic malignancies. Furthermore, though almost all trials report some race information, FDA guidelines are not universally followed. There is a disproportionate disease burden of lung cancer in under-represented race communities, and clinical trials should prioritize racial diversity and inclusion efforts.

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No potential conflict of interest was reported by the author(s).

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Racial Diversity and Reporting in United States Food and Drug Administration Registration Trials for Thoracic Malignancies from 2006 to 2020

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Racial Diversity and Reporting in United States Food and Drug Administration Registration Trials for Thoracic Malignancies from 2006 to 2020

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