M. Lythgoe (London, United Kingdom)
Author Of 1 Presentation
157P - Racial Diversity and Reporting in FDA registration trials for Breast Cancer from 2006-21
Abstract
Background
In 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.
Methods
We 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.
Results
38 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%
BC Subtype No. Licensing Trials Total Participants White NHPI Black Asian AIAN Other/ Multiple Unknown/Missing Hormone positive 13 7768 (100%) 5746 (73.9%) 1 (0.1%) 171 (2.2%) 1283 (16.5%) 56 (0.7%) 258 (3.3%) 253 (3.3%) HER2 positive 18 21785 (100%) 8907 (40.9%) 4 (0.1%) 349 (1.6%) 2048 (9.4%) 115 (0.5%) 336 (1.5%) 10026 (46.0%) Triple negative 3 1857 (100%) 1270 (68.4%) 1 (0.1%) 104 (5.6%) 339 (18.2%) 52 (2.8%) 24 (1.3%) 67 (3.6%) Other (e.g. BRCA mutant) 7 4671 (100%) 3572 (76.5%) 2 (0.1%) 124 (2.7%) 524 (11.2%) 5 (0.1%) 222 (4.7%) 222 (4.7%) Total 41 36081 (100%) 19495 (54.0%) 8 (0.1%) 748 (2.1%) 4194(11.6%) 228 (0.6%) 840 (2.3%) 10568 (29.3%)
Conclusions
This study revealed white subjects are overly represented within all BC licensing trials. Inclusion of black trial participants, particularly in triple negative BC trials is disproportionately low when compared to disease burden. Since introduction of new FDA race reporting guidance, recording in licensing publications has improved.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Presenter Of 1 Presentation
157P - Racial Diversity and Reporting in FDA registration trials for Breast Cancer from 2006-21
Abstract
Background
In 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.
Methods
We 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.
Results
38 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%
BC Subtype No. Licensing Trials Total Participants White NHPI Black Asian AIAN Other/ Multiple Unknown/Missing Hormone positive 13 7768 (100%) 5746 (73.9%) 1 (0.1%) 171 (2.2%) 1283 (16.5%) 56 (0.7%) 258 (3.3%) 253 (3.3%) HER2 positive 18 21785 (100%) 8907 (40.9%) 4 (0.1%) 349 (1.6%) 2048 (9.4%) 115 (0.5%) 336 (1.5%) 10026 (46.0%) Triple negative 3 1857 (100%) 1270 (68.4%) 1 (0.1%) 104 (5.6%) 339 (18.2%) 52 (2.8%) 24 (1.3%) 67 (3.6%) Other (e.g. BRCA mutant) 7 4671 (100%) 3572 (76.5%) 2 (0.1%) 124 (2.7%) 524 (11.2%) 5 (0.1%) 222 (4.7%) 222 (4.7%) Total 41 36081 (100%) 19495 (54.0%) 8 (0.1%) 748 (2.1%) 4194(11.6%) 228 (0.6%) 840 (2.3%) 10568 (29.3%)
Conclusions
This study revealed white subjects are overly represented within all BC licensing trials. Inclusion of black trial participants, particularly in triple negative BC trials is disproportionately low when compared to disease burden. Since introduction of new FDA race reporting guidance, recording in licensing publications has improved.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.