ABSTRACT
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.
Subject(s)
Ethnic and Racial Minorities , Immune Checkpoint Inhibitors , Aged , Ethnicity , Female , Hispanic or Latino , Humans , Minority Groups , United StatesABSTRACT
Plants have the natural ability to withstand stress conditions through metabolic adjustments. The present study aimed at investigating the effects of titanium dioxide nanoparticles (TiO2 NPs) application (0, 25, 50, 150, 250, 500, and 750 mg kg-1) in phosphorus-deficient soil in terms of growth responses, P contents, and metabolic alterations in rice. TiO2 NPs application increased shoot length up to 14.5%. Phosphorus contents in rice roots, shoots, and grains were increased by 2.6-, 2.4-, and 1.3-fold, respectively, at 750 mg kg-1 of TiO2 NPs. Gas chromatography-mass spectrometry (GC-MS)-based metabolomics revealed increased levels of amino acids, palmitic acid, and glycerol content in grains resulting from plants grown in 750 mg kg-1 TiO2 NPs-treated soil. Furthermore, no translocation of TiO2 NPs from the treated soil to rice grains was detected by inductively coupled plasma-optical emission spectrometry (ICP-OES), which suggests no risk of TiO2 NPs intake via grain consumption. The observed data indicates the strong relationship among NPs application, P contents, and metabolic alterations.