TY - JOUR
T1 - Disparities in Representation of Women, Older Adults, and Racial/Ethnic Minorities in Immune Checkpoint Inhibitor Trials
AU - Riaz, Irbaz B.
AU - Islam, Mahnoor
AU - Khan, Ahsan Masood
AU - Naqvi, Syed Arsalan Ahmed
AU - Siddiqi, Rabbia
AU - Khakwani, Kaneez Zahra Rubab
AU - Asghar, Noureen
AU - Ikram, Waleed
AU - Hussain, Syed A.
AU - Singh, Parminder
AU - Warner, Jeremy L.
AU - Sonpavde, Guru P.
AU - Odedina, Folakemi T.
AU - Kehl, Kenneth L.
AU - Duma, Narjust
AU - Bryce, Alan H.
N1 - Publisher Copyright:
© 2022 Elsevier Inc.
PY - 2022/8
Y1 - 2022/8
N2 - Purpose: We aim to describe reporting and representation of minority patient populations in immune checkpoint inhibitor (ICI) clinical trials and assess predictors of enrollment disparity. Methods: Trial-level data were acquired from eligible phase II and III trials. Population-based estimates were acquired from the SEER 18 and Global Burden of Disease incidence databases. Trials reporting race, age, and sex were summarized using descriptive statistics. Enrollment-incidence ratio (EIR) was used to assess representation of subgroups. Average annual percentage change (AAPC) in EIR was calculated using Joinpoint Regression Analysis. Trial-level characteristics associated with EIR were assessed using multivariable linear regression. Results: A total of 107 trials with 48,095 patients were identified. Participation of Black, White, Asian, Native American, Pacific Islander, and Hispanic participants was reported in 65 (61%), 77 (72%), 68 (64%), 40 (37%,) and 24 trials (22%), respectively. Subgroup analyses of clinical outcomes by race, age, and sex were reported in 17 (22%), 62 (78%), and 57 (57%) trials, respectively. Women (trial proportion [TP]: 32%; EIR: 0.90 [95% confidence interval [CI]: 0.84-0.96]), patients aged ≥65 years (TP: 42%; EIR: 0.78 [95% CI: 0.72-0.84]), Black participants (TP: 1.9%; EIR: 0.17 [95% CI: 0.13-0.22]) and Hispanics (TP: 5.9%; EIR: 0.67 [95% CI: 0.53-0.82]) were underrepresented. Representation of Black patients decreased significantly from 2009 to 2020 (AAPC: −23.13). Black participants were significantly underrepresented in phase III trials (P < .001). Conclusion: The reporting of participation by racial or ethnic subgroup categories is inadequate. Women, older adults, as well as Black and Hispanic participants are significantly underrepresented in ICI clinical trials.
AB - Purpose: We aim to describe reporting and representation of minority patient populations in immune checkpoint inhibitor (ICI) clinical trials and assess predictors of enrollment disparity. Methods: Trial-level data were acquired from eligible phase II and III trials. Population-based estimates were acquired from the SEER 18 and Global Burden of Disease incidence databases. Trials reporting race, age, and sex were summarized using descriptive statistics. Enrollment-incidence ratio (EIR) was used to assess representation of subgroups. Average annual percentage change (AAPC) in EIR was calculated using Joinpoint Regression Analysis. Trial-level characteristics associated with EIR were assessed using multivariable linear regression. Results: A total of 107 trials with 48,095 patients were identified. Participation of Black, White, Asian, Native American, Pacific Islander, and Hispanic participants was reported in 65 (61%), 77 (72%), 68 (64%), 40 (37%,) and 24 trials (22%), respectively. Subgroup analyses of clinical outcomes by race, age, and sex were reported in 17 (22%), 62 (78%), and 57 (57%) trials, respectively. Women (trial proportion [TP]: 32%; EIR: 0.90 [95% confidence interval [CI]: 0.84-0.96]), patients aged ≥65 years (TP: 42%; EIR: 0.78 [95% CI: 0.72-0.84]), Black participants (TP: 1.9%; EIR: 0.17 [95% CI: 0.13-0.22]) and Hispanics (TP: 5.9%; EIR: 0.67 [95% CI: 0.53-0.82]) were underrepresented. Representation of Black patients decreased significantly from 2009 to 2020 (AAPC: −23.13). Black participants were significantly underrepresented in phase III trials (P < .001). Conclusion: The reporting of participation by racial or ethnic subgroup categories is inadequate. Women, older adults, as well as Black and Hispanic participants are significantly underrepresented in ICI clinical trials.
KW - Clinical trial enrolment
KW - Disparities
KW - Immune checkpoint inhibitors
KW - Older adults
KW - Race
KW - Women
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U2 - 10.1016/j.amjmed.2022.03.042
DO - 10.1016/j.amjmed.2022.03.042
M3 - Article
C2 - 35483426
AN - SCOPUS:85132819476
SN - 0002-9343
VL - 135
SP - 984-992.e6
JO - American Journal of Medicine
JF - American Journal of Medicine
IS - 8
ER -