PMID- 37883087
OWN - NLM
STAT- MEDLINE
DCOM- 20231027
LR  - 20231029
IS  - 2574-3805 (Electronic)
IS  - 2574-3805 (Linking)
VI  - 6
IP  - 10
DP  - 2023 Oct 2
TI  - Eligibility for Human Leukocyte Antigen-Based Therapeutics by Race and Ethnicity.
PG  - e2338612
LID - 10.1001/jamanetworkopen.2023.38612 [doi]
LID - e2338612
AB  - IMPORTANCE: The development of therapeutics for patients who are positive for 
      specific human leukocyte antigen (HLA) subtypes evokes the question of whether 
      certain racial and ethnic groups are more or less likely to be eligible for novel 
      products. OBJECTIVE: To determine whether racial and ethnic inequities were 
      present with regard to trial eligibility in trials investigating a therapeutic 
      restricted to patients with specific HLA subtypes. DESIGN, SETTING, AND 
      PARTICIPANTS: This cross-sectional study included all clinical trials registered 
      in ClinicalTrials.gov through March 18, 2022, that investigated an interventional 
      study of a therapeutic strategy and restricted participants to those with at 
      least 1 HLA subtype. Data were analyzed from May 8 to July 1, 2022. MAIN OUTCOMES 
      AND MEASURES: The type of therapeutics used in trials, the condition under study, 
      the HLA subtypes used, and the likelihood of being enrolled in such a trial 
      according to race and ethnicity. RESULTS: Of 2135 trials identified, 263 met 
      inclusion criteria. Overall, the estimated likelihood of being eligible for an 
      HLA-based trial was 50.3%. Individuals of African American descent had the lowest 
      likelihood of eligibility (33.0%), while being an individual of European descent 
      conferred the highest (53.0%; 1.6 times more likely than African American 
      individuals). Most trials studied anticancer therapeutics (258 [98.1%; 95% 
      CI, 96.4%-99.7%]), and most were a therapeutic vaccine (179 [68.1%; 95% 
      CI, 62.4%-73.7%]). The HLA-A*02:01 allele and the HLA-A2 serotype were the most 
      frequent HLA subtypes for trial eligibility. The frequency of the HLA-A*02:01 
      allele in the population varied, with 11.9% (95% CI, 11.8%-12.0%) in African or 
      African American individuals and 27.1% (95% CI, 27.1%-27.1%) in individuals of 
      European descent. CONCLUSIONS AND RELEVANCE: The findings of this cross-sectional 
      study suggest that enrollment restrictions for clinical trials investigating 
      novel HLA therapeutics may be associated with racial and ethnic inequities with 
      regard to trial eligibility. Overcoming these restrictions poses biological 
      challenges, but solutions must be implemented to provide equal access to 
      innovative strategies regardless of race or ethnicity.
FAU - Olivier, Timothee
AU  - Olivier T
AD  - Department of Oncology, Geneva University Hospital, Geneva, Switzerland.
AD  - Department of Epidemiology and Biostatistics, University of California, San 
      Francisco.
FAU - Haslam, Alyson
AU  - Haslam A
AD  - Department of Epidemiology and Biostatistics, University of California, San 
      Francisco.
FAU - Tuia, Jordan
AU  - Tuia J
AD  - Department of Epidemiology and Biostatistics, University of California, San 
      Francisco.
FAU - Prasad, Vinay
AU  - Prasad V
AD  - Department of Epidemiology and Biostatistics, University of California, San 
      Francisco.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20231002
PL  - United States
TA  - JAMA Netw Open
JT  - JAMA network open
JID - 101729235
RN  - 0 (HLA Antigens)
RN  - 0 (HLA-A Antigens)
SB  - IM
MH  - Humans
MH  - *Ethnicity
MH  - Cross-Sectional Studies
MH  - *HLA Antigens
MH  - Alleles
MH  - HLA-A Antigens
PMC - PMC10603498
COIS- Conflict of Interest Disclosures: Dr Prasad reported receiving research funding 
      from Arnold Ventures LLC through a grant made to UCSF; royalties for books and 
      writing from Johns Hopkins Press, MedPage, and the Free Press; and consulting 
      fees from UnitedHealthcare and OptumRX. He also reported receiving revenue from 
      Patreon, YouTube, and Substack for the podcasts Plenary Session, VPZD, and 
      Sensible Medicine; for the newsletters Sensible Medicine, The Drug Development 
      Letter, and VP's Observations and Thoughts; and for the YouTube channel Vinay 
      Prasad MD MPH. No other disclosures were reported.
EDAT- 2023/10/26 12:42
MHDA- 2023/10/27 06:43
PMCR- 2023/10/26
CRDT- 2023/10/26 11:33
PHST- 2023/10/27 06:43 [medline]
PHST- 2023/10/26 12:42 [pubmed]
PHST- 2023/10/26 11:33 [entrez]
PHST- 2023/10/26 00:00 [pmc-release]
AID - 2811111 [pii]
AID - zoi231133 [pii]
AID - 10.1001/jamanetworkopen.2023.38612 [doi]
PST - epublish
SO  - JAMA Netw Open. 2023 Oct 2;6(10):e2338612. doi: 
      10.1001/jamanetworkopen.2023.38612.