Abstract
Significant inequities based on sex, race, ethnicity, and age exist among participants
in clinical trials dedicated to investigating medical disease states. While general
demographic data regarding blood donors and blood transfusion recipients have been
studied extensively, the demographics of participants involved in blood donation and
blood transfusion clinical trials are unknown. We performed a cross-sectional analysis
of United States (U.S.) -based interventional blood donation and blood transfusion
clinical trials registered with Clinicaltrials.gov to ascertain the composition of
participants’ sex, race, ethnicity, and age, as well as diagnostic conditions and
geographic trial locations.Eligible trials were undertaken between July 2003 and August
2020. Thirty-eight of the one hundred and fifty-two blood donation and blood transfusion
clinical trials met inclusion criteria (seven blood donation and thirty-one blood
transfusion trials). While the participant dataset from trial reports were incomplete,
100 % of blood donation trials reported sex and age, 71.4 % reported race, and 42.3
% reported ethnicity. 96.8 % of blood transfusion trials reported sex, 51.6 % reported
race, 38.7 % reported ethnicity, and 100 % reported age. Among 2720 participants enrolled
in the seven blood donation trials, females were underrepresented (28.5 %) compared
to U.S. Census data. Conversely, female (50.8 %) and male participants (49.2 %) were
equally represented in blood transfusion trials (9255 participants). White participants
were overrepresented in blood donation trials (73.4 %), while Hispanic or Latinos
were underrepresented in both blood donation (7.7 %) and blood transfusion (8.2 %)
trials compared to 2019 U.S.Census data. Only 8.3 % of blood transfusion clinical
trials open to adults reported including older adults (i.e., ≥ 65yo). Despite mandatory
reporting requirements and an already established framework, researchers frequently
failed to report complete demographics of blood donation and blood transfusion clinical
trial participants. Furthermore, various demographic groups were underrepresented
in blood donation and/or blood transfusion clinical trials, including females, Hispanic
or Latino individuals, and older adults. These findings demonstrate the need for implementation
of strategies to ensure equitable representation of individuals in blood donation
and transfusion clinical trials.
Keywords
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Article info
Publication history
Published online: February 09, 2023
Accepted:
February 7,
2023
Received in revised form:
February 3,
2023
Received:
June 17,
2022
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
© 2023 Elsevier Ltd. All rights reserved.
