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Temporal Trends and Predictors for Cancer Clinical Trial Availability for Medically Underserved Populations.

ABSTRACT: Lack of access to available cancer clinical trials has been cited as a key factor limiting trial accrual, particularly among medically underserved populations. We examined the trends and factors in clinical trial availability within a major U.S. safety-net hospital system.We identified cancer clinical trials activated at the Harold C. Simmons Cancer from 1991 to 2014 and recorded the characteristics of the trials that were and were not activated at the Parkland Health and Hospital System satellite site. We used univariate and multivariate logistic regression to determine the association between trial characteristics and nonactivation status, and chi-square analysis to determine the association between the trial characteristics and the reasons for nonactivation.A total of 773 trials were identified, of which 152 (20%) were not activated at Parkland. In multivariable analysis, nonactivation at Parkland was associated with trial year, sponsor, and phase. Compared with the 1991-2006 period, clinical trials in the 2007-2014 period were almost eightfold more likely not to be activated at Parkland. The most common reasons for nonactivation at Parkland were an inability to perform the study procedures (27%) and the startup costs (15%).Over time, in this single-center setting, a decreasing proportion of cancer clinical trials were available to underserved populations. Trial complexity and costs appeared to account for much of this trend. Efforts to overcome these barriers will be key to equitable access to clinical trials, efficient accrual, and the generalizability of the results.Despite numerous calls to increase and diversify cancer clinical trial accrual, the present study found that cancer clinical trial activation rates in a safety-net setting for medically underserved populations have decreased substantially in recent years. The principal reasons for study nonactivation were expenses and an inability to perform the study-related procedures, reflecting the increasing costs and complexity of cancer clinical trials. Future efforts need to focus on strategies to mitigate the increasing disparity in access to clinical research and cutting-edge therapies, which also threatens to hinder study accrual, completion rates, and generalizability.

SUBMITTER: Gerber DE

PROVIDER: S-EPMC4571795 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Influenza infection in pregnant women is associated with increased risk of morbidity and mortality. Despite recommendations for all women to receive the seasonal influenza vaccine during pregnancy, vaccination rates among pregnant women in the U.S. have remained around 50%. The objective of this study was to evaluate clinical and demographic factors associated with antenatal influenza vaccination in a medically underserved population of women. We conducted a retrospective cohort study at Grady Memorial Hospital, a large safety-net hospital in Atlanta, Georgia, from July 1, 2016, to June 30, 2018. Demographic and clinical characteristics were abstracted from the electronic medical record. The Kotelchuck index was used to assess prenatal care adequacy. Relative risks and 95% confidence intervals for associations between receipt of influenza vaccine and prenatal care adequacy, demographic characteristics, and clinical characteristics were calculated using multivariable log-binominal models. Among 3723 pregnant women with deliveries, women were primarily non-Hispanic black (68.4%) and had Medicaid as their primary insurance type (87.9%). The overall vaccination rate was 49.8% (1853/3723). Inadequate prenatal care adequacy was associated with a lower antenatal influenza vaccination rate (43.5%), while intermediate and higher levels of prenatal care adequacy were associated with higher vaccination rates (66.9-68.3%). Hispanic ethnicity, non-Hispanic other race/ethnicity, interpreter use for a language other than Spanish, and preexisting diabetes mellitus were associated with higher vaccination coverage in multivariable analyses. Among medically underserved pregnant women, inadequate prenatal care utilization was associated with a lower rate of antenatal influenza vaccination. Socially disadvantaged women may face individual and structural barriers when accessing prenatal care, suggesting that evidenced-based, tailored approaches may be needed to improve prenatal care utilization and antenatal influenza vaccination rates.

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Temporal Trends and Predictors for Cancer Clinical Trial Availability for Medically Underserved Populations.

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