Imperial College London
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DrJonathanKrell

Faculty of Medicine, Department of Surgery & Cancer

Clinical SL in Medical Oncology (Gynaecological Oncology)
 
 
 
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Contact

 

j.krell

 
 
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Location

 

Institute of Reproductive and Developmental BiologyHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Lythgoe:2021:10.1038/s41391-021-00361-0,
author = {Lythgoe, MP and Krell, J and Savage, P and Prasad, V},
doi = {10.1038/s41391-021-00361-0},
journal = {Prostate Cancer and Prostatic Diseases},
pages = {1208--1211},
title = {Race reporting and diversity in US food and drug administration (FDA) registration trials for prostate cancer; 2006-2020.},
url = {http://dx.doi.org/10.1038/s41391-021-00361-0},
volume = {24},
year = {2021}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BACKGROUND: There is significant racial disparity in prostate cancer (PCa) in terms of incidence, treatment, and outcomes. Racial diversity and compliance with FDA race reporting guidelines in PCa drug registration trials are unknown. We analyzed racial diversity and race reporting in drug licensing trials for PCa. METHODS: New drug authorizations for PCa from 2006 to 2020 were identified. The corresponding licensing trial publications were analyzed to check compliance with current FDA recommendations for race reporting. If race was unreported, the clinical trial report was analyzed to determine participant recruitment by race and lead the recruiting country. RESULTS: During the study period, 17 new drug registrations for the management of PCa involving ten unique drugs were identified. In total, 18,455 participants were included in FDA registration trials, of which 76.3% were white or Caucasian, 7.9% Asian, 2.9% Black or African American, 0.5% American Indian or Alaskan Native, 0.1% Native Hawaiian or other Pacific Islander, 1.8% other or multiple races and 10.5% unknown. 53% of trials reported race in the licensing publication, however of this only 55% met current FDA recommendations. When the race was unreported in the licensing publication, 88% of studies had further information in the clinical study report. CONCLUSION: We found a significant under-representation of non-white participants in FDA drug registration trials for PCa. Race reporting in licensing publication is inconsistent and both FDA and International Committee of Medical Journal Editors guidelines are not being universally followed. Given the disproportionality of the disease burden of PCa, recruitment of Black and other minority participants to trials should be a research priority.
AU  - Lythgoe,MP
AU  - Krell,J
AU  - Savage,P
AU  - Prasad,V
DO  - 10.1038/s41391-021-00361-0
EP  - 1211
PY  - 2021///
SN  - 1365-7852
SP  - 1208
TI  - Race reporting and diversity in US food and drug administration (FDA) registration trials for prostate cancer; 2006-2020.
T2  - Prostate Cancer and Prostatic Diseases
UR  - http://dx.doi.org/10.1038/s41391-021-00361-0
UR  - https://www.ncbi.nlm.nih.gov/pubmed/33859363
UR  - https://www.nature.com/articles/s41391-021-00361-0
UR  - http://hdl.handle.net/10044/1/88116
VL  - 24
ER  -
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