Imperial College London
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Dr Mark P. Lythgoe

Faculty of Medicine, Department of Surgery & Cancer

Research Postgraduate
 
 
 
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Contact

 

m.lythgoe

 
 
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Location

 

Institute of Reproductive and Developmental BiologyHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Lythgoe:2021:10.1016/j.annonc.2021.03.171,
author = {Lythgoe, MP and Krell, J and Kenny, L and Khaki, AR},
doi = {10.1016/j.annonc.2021.03.171},
journal = {Annals of Oncology},
pages = {S88--S88},
title = {157P Racial diversity and reporting in FDA registration trials for breast cancer from 2006 to 2021},
url = {http://dx.doi.org/10.1016/j.annonc.2021.03.171},
volume = {32},
year = {2021}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BackgroundIn the USA, there are >250,000 diagnoses of breast cancer (BC) annually, with significant racial disparities in incidence, subtype and outcomes. FDA clinical trials guidance recommend 5 categories of race reporting (White, Black, Asian, American Indian/Alaskan Native [AIAN] & Native Hawaiian/Pacific Islander [NHPI]). Furthermore, International Committee of Medical Journal Editors (ICMJE) guidance recommend authors, as a minimum, provide descriptive data for race. We analysed racial diversity in BC drug registration trials and compliance with FDA/ICMJE guidance.MethodsWe performed a retrospective review of BC FDA market authorisations from 2006 to 2021. Clinical trial publications cited on the licensing label were identified and analysed. If race was under-reported (<3 groups), the study report on clinicaltrials.gov was analysed. The total proportion of racial group participation and number of registration trials with adequate reporting was determined.Results38 new licensing indications were identified, involving 41 trials and 23 drugs. Overall, 36,081 patients participated: 19,495 (54.0%) White, 4194 (11.6%) Asian, 748 (2.1%) Black, 228 (0.6%) AIAN, 8 (0.1%) NHPI, 840 (2.3%) other and 10568 (29.3%) unknown. The table shows breakdown by BC subtype. Race was reported in 29 (70%) licensing trial publications, of which 7 provided only limited data. For licensing trials where no race data was reported, a further 6 (14%) had information within the study report. In the 10 years prior to the introduction of new FDA guidance in 2016 only 50% of registration studies met FDA/ICJME race reporting requirements. Since 2016 this has improved to 85%
AU  - Lythgoe,MP
AU  - Krell,J
AU  - Kenny,L
AU  - Khaki,AR
DO  - 10.1016/j.annonc.2021.03.171
EP  - 88
PY  - 2021///
SN  - 0923-7534
SP  - 88
TI  - 157P Racial diversity and reporting in FDA registration trials for breast cancer from 2006 to 2021
T2  - Annals of Oncology
UR  - http://dx.doi.org/10.1016/j.annonc.2021.03.171
UR  - https://www.sciencedirect.com/science/article/pii/S0923753421010498?via%3Dihub
VL  - 32
ER  -
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