Racial disparities in biomarker testing and clinical trial enrollment in non-small cell lung cancer (NSCLC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9005-9005
Author(s):  
Debora S. Bruno ◽  
Lisa M. Hess ◽  
Xiaohong Li ◽  
Eric Wen Su ◽  
Yajun Emily Zhu ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Racial Disparities ◽  
Trial Participation ◽  
First Line ◽  
Metastatic Nsclc ◽  
Black Patients ◽  
Biomarker Testing ◽  
Clinical Trial Enrollment ◽  
White Patients

9005 Background: Cancer racial disparities may exist at many levels in the health care system, from screening to timely diagnosis and treatments received, as well as clinical trial enrollment. This study investigated differences in black versus white race among patients with NSCLC undergoing biomarker testing and clinical trial enrollment in the US. Methods: This retrospective observational study utilized the Flatiron Health database, which includes longitudinal data of patients with advanced/metastatic NSCLC. Patients were eligible if they had evidence of systemic therapy in the database from 1/1/2017 through 10/30/2020. Descriptive analyses summarized differences by race in biomarker testing and trial enrollment. Multivariable regression examined the relationship between these factors. Results: A total of 14,768 patients were eligible: 9,793 (66.3%) were white and 1,288 (8.7%) were black. 76.4% of white patients and 73.6% of black patients underwent at least one single molecular test or comprehensive genomic analysis (p = 0.03). Next-generation sequencing (NGS) was performed among 50.1% of white patients and 39.8% of black patients (p < 0.0001. Trial participation was observed among 3.9% of white and 1.9% of black patients (p = 0.0002). There was a statistically significant association between race (white vs black) and both biomarker testing (ever vs never) and trial participation (yes vs no) (both p < 0.001, unadjusted chi square). Differences in NGS testing, baseline biomarker testing, and race were retained as statistically significant (p < 0.01) in adjusted regression analyses. The receipt of first-line targeted therapy was comparable between white and black patients (10.2% and 9.2%, respectively, p = 0.24); however, this summary did not consider biomarker test results. First line use of pembrolizumab+carboplatin+pemetrexed was observed among 19.8% of white and 22.6% of black patients; carboplatin+paclitaxel was observed among 16.5% and 18.6%, and single-agent pembrolizumab was observed among 14.8% and 11.5%, respectively. Conclusions: The use of NGS-based testing, which is recommended by the National Comprehensive Cancer Network Clinical Guidelines in Oncology for patients with advanced/metastatic NSCLC, is the most notable disparity among black patients, with more than a 10 percentage-point difference in receipt of this testing versus white counterparts. This may in part contribute to the more than double the rate of participation in clinical trials observed among white patients, as many second line and beyond trials utilize molecular targets as inclusion criteria. While multiple factors are known to impact health care disparities, access to and receipt of appropriate biomarker testing may be an attenable goal in order to ensure equal access to quality care.

Racial disparities in comprehensive biomarker testing and clinical trial enrollment among patients with metastatic colorectal cancer (mCRC).

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 125-125
Author(s):  
Lisa M. Hess ◽  
Debora S. Bruno ◽  
Xiaohong Li ◽  
Eric Wen Su ◽  
Monaliben Patel
Keyword(s):  
Clinical Trial ◽  
Racial Disparities ◽  
Racial Differences ◽  
Significant Relationship ◽  
Trial Participation ◽  
Regression Analyses ◽  
Significant Difference ◽  
The Us ◽  
Biomarker Testing ◽  
Clinical Trial Enrollment

125 Background: Racial disparities may exist at many levels in the health care system; in oncology, yet little is known about racial disparities in biomarker testing and clinical trial enrollment among patients with mCRC. This study was designed to explore racial differences in comprehensive biomarker testing and clinical trial enrollment in the US using a large real-world database. Methods: This retrospective observational study utilized the Flatiron Health electronic health records database, which includes longitudinal data from patients diagnosed with mCRC. Patients with mCRC were eligible for this study if they had evidence of systemic therapy from 1/1/2017 through 10/30/2020 and were alive for at least 120 days after metastatic diagnosis. Unadjusted analyses summarized differences in biomarker testing and clinical trial enrollment between White and Black race, adjusted regression analyses were conducted using all baseline variables as covariates. These data are de-identified and are not considered human subjects research in accordance with the US Code of Federal Regulations (45 CFR Part 46). Results: A total of 7,879 patients were eligible: 4,803 (61.0%) were White and 838 (10.6%) were Black. Comprehensive testing by next-generation sequencing (NGS) was received by 51.6% and 41.8% of patients who were White and Black, respectively (p < 0.0001). There was no significant difference in clinical trial participation across all lines of therapy (2.9%, White and 2.9% Black). There was a statistically significant relationship between NGS-based testing and clinical trial enrollment (p < 0.0001), however, race was not identified a moderating factor in this relationship in adjusted regression analyses. The receipt of molecularly-targeted therapy was comparable between both races (11.9% and 9.7% for White and Black, respectively; p = 0.06). Patients received FOLFOX+bevacizumab most commonly in the first line (34.3% White; 40.5% Black), all other regimens were within 2 percentage points between racial groups. Targeted agents were each used by less than 7.4% of the study population. Conclusions: The use of NGS-based testing is significantly different by race in this database. The significant relationship between NGS testing and clinical trial enrollment at any time in the database did not appear to be moderated by race; however, descriptive analyses suggest that the ongoing analyses by line of therapy and considering timing of testing may better quantify these relationships. These data may not be generalizable to the entire US population as they are obtained from a single database that is limited to practices using this EHR system.

Increasing participation in breast cancer research: (INSPIRE-BrC).

2014 ◽  
Vol 32 (26_suppl) ◽  
pp. 53-53
Author(s):  
Brandi Robinson ◽  
Sandra M. Swain
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Primary Outcome Measure ◽  
Test Method ◽  
Trial Participation ◽  
Lower Survival Rate ◽  
Black Patients ◽  
Clinical Trial Enrollment ◽  
The Impact

53 Background: Increasing black patients’ participation in cancer clinical trials is particularly important because of the population’s lower survival rate. Accrual to clinical trials remains low among the general population (1 to 3%), with recruitment of blacks the lowest of all groups at 0.5 to 1.5%. Clinical trials are key to developing new methods to prevent, detect, and treat cancer. INSPIRE-BrC aims to increase trial participation rates among black patients with breast cancer and examine the relationship between the intervention and attitudes/beliefs on the decision to participate. Methods: A sample size of 123 black patients with breast cancer at five MedStar sites will view a 15 minute, culturally tailored video about clinical trials, which targets six cultural and attitudinal barriers to participation. A pre-test/post-test method is used to determine the impact of the video on three variables — likely participation in therapeutic clinical trials; attitudes toward therapeutic clinical trials (assessed based on the 6 barriers); and actual trial enrollment. Expected Findings: We hypothesize that the intervention will increase clinical trial enrollment compared to our 2012 clinical trial enrollment baseline rate of 6% (22/384) for black patients with breast cancer in five MedStar hospitals. The primary outcome measure is the proportion of black patients with breast cancer who agree to participate in a therapeutic clinical trial among those who sign consent to INSPIRE-BrC. Study findings have the potential to increase patient recruitment as a promising tool for rapid dissemination of a theory-driven, evidence-based model to enhance clinical trial accrual among black patients with cancer. [Table: see text]

Disparities in clinical trials participation in a vertically integrated care delivery system.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 128-128
Author(s):  
Ahmed Megahed ◽  
Gary L Buchschacher ◽  
Ngoc J. Ho ◽  
Reina Haque ◽  
Robert Michael Cooper
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Healthcare System ◽  
Care Delivery ◽  
Trial Participation ◽  
Cancer Type ◽  
Clinical Trial Participation ◽  
Integrated Healthcare ◽  
Clinical Trial Enrollment ◽  
Asian Pacific

128 Background: Sparse data exists on the diversity clinical trial enrollment in community settings. This information is important to ensure equity of care and generalizability of results. Methods: We conducted a retrospective cohort study of members of an integrated healthcare system diagnosed with invasive malignancies (excluding non-melanoma skin cancers) between 2013-2017 to examine demographics of the oncology population compared to those who enrolled in a clinical trial. Logistic regression was used to assess correlates of clinical trial participation, comparing general and screened samples to enrolled sample. Odds ratios were adjusted for gender, geocoded median household income, cancer type, and stage. Results: Of the 84,977 patients with a cancer diagnosis, N = 2606 were screened for clinical trial participation and consented, and of those N = 1372 enrolled. The percent of Latinx (25.8% vs 24.0%; OR 0.9? CI 0.72-1.05) and African American/Black (10.9% vs 11.1%; OR 0.92 CI 0.75-1.11) clinical trial participation mirrored that of the general oncology population, respectively using Non-Hispanic Whites as reference. Asian/Pacific Islander had equal odds of clinical trial enrollment (OR 1.08 CI 0.92-1.27). The enrolled population was younger than the general oncology population. Conclusions: This study suggests that in an integrated healthcare system with equal access to care, the clinical trials population is well representative of its general oncology population.[Table: see text]

Effect of an antiracism intervention on disparities in time to lung cancer surgery.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 101-101
Author(s):  
Jacob Newton Stein ◽  
Samuel Cykert ◽  
Christina Yongue ◽  
Eugenia Eng ◽  
Isabella Kathryn Wood ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Racial Disparities ◽  
Cancer Care ◽  
Retrospective Cohort ◽  
Early Stage ◽  
Lung Cancer Surgery ◽  
Cancer Surgery ◽  
Early Stage Lung Cancer ◽  
Black Patients ◽  
White Patients

101 Background: Racial disparities are well described in the management of early-stage lung cancer, with Black patients less likely to receive potentially curative surgery than non-Hispanic Whites. A multi-site pragmatic trial entitled Accountability for Cancer Care through Undoing Racism and Equity (ACCURE), designed in collaboration with community partners, eliminated racial disparities in lung cancer surgery through a multi-component intervention. The study involved real-time electronic health record (EHR) monitoring to identify patients not receiving recommended care, a nurse navigator who reviewed and addressed EHR alerts daily, and race-specific feedback provided to clinical teams. Timeliness of cancer care is an important quality metric. Delays can lead to disease progression, upstaging, and worse survival, and Black patients are more likely to experience longer wait times to lung cancer surgery. Yet interventions to reduce racial disparities in timely delivery of lung cancer surgery have not been well studied. We evaluated the effect of ACCURE on timely receipt of lung cancer surgery. Methods: We analyzed data of a retrospective cohort at five cancer centers gathered prior to the ACCURE intervention and compared results with prospective data collected during the intervention. We calculated mean time from clinical suspicion of lung cancer to surgery and evaluated the proportion of patients who received surgery within 60 days stratified by race. We performed a t-test to compare mean days to surgery and chi2 for the delivery of surgery within 60 days. Results: 1320 patients underwent surgery in the retrospective arm, 160 were Black. 254 patients received surgery in the intervention arm, 85 were Black. Results are summarized in Table. Mean time to surgery in the retrospective cohort was 41.8 days, compared with 25.5 days in the intervention cohort (p<0.01). In the retrospective cohort, 68.8% of Black patients received surgery within 60 days versus 78.9% of White patients (p<0.01). In the intervention, the difference between Blacks and Whites with respect to surgery within 60 days was no longer significant (89.41% of Black patients vs 94.67% of White patients, p=0.12). Conclusions: Racial disparities exist in the delivery of timely lung cancer surgery. The ACCURE intervention improved time to surgery and timeliness of surgery for Black and White patients with early-stage lung cancer. A combination of real-time EHR monitoring, nurse navigation, and race-based feedback markedly reduced racial disparities in timely lung cancer care. [Table: see text]

Racial Disparities in Invasive Management for Patients With Acute Myocardial Infarction With Chronic Kidney Disease

2021 ◽  
Author(s):  
Jennifer A. Rymer ◽  
Shuang Li ◽  
Patrick H. Pun ◽  
Laine Thomas ◽  
Tracy Y. Wang
Keyword(s):  
Myocardial Infarction ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Racial Disparities ◽  
Odds Ratio ◽  
Adjusted Odds Ratio ◽  
Logistic Regression Models ◽  
Black Patients ◽  
Invasive Management ◽  
White Patients

Background: Due to increased risks of contrast nephropathy, chronic kidney disease (CKD) can deter consideration of invasive management for patients with myocardial infarction (MI). Black patients have a higher prevalence of CKD. Whether racial disparities exist in the use of invasive MI management for patients with CKD presenting with MI is unknown. Methods: We examined 717 012 White and 99 882 Black patients with MI treated from 2008 to 2017 at 914 hospitals in the National Cardiovascular Data Registry Chest Pain—MI Registry. CKD status was defined as estimated glomerular filtration rate (eGFR) ≥90 mL/(min·1.73 m 2 ; no CKD), eGFR <90 but ≥60 (mild), eGFR <60 but ≥30 (moderate), and eGFR <30 or dialysis (severe). We used multivariable logistic regression models to examine the interaction of race and CKD severity in invasive MI management. Results: Among those with MI, Black patients were more likely than White patients to have CKD (eGFR <90; 61.4% versus 58.5%; P <0.001). Among those with MI and CKD, Black patients were more likely than White patients to have severe CKD (21.2% versus 12.4%; P <0.001). Patients with CKD were more likely than those without CKD to have diabetes or heart failure; Black patients with CKD were more likely to have these comorbidities when compared with White patients with CKD (all P <0.0001). Black race and CKD were associated with a lower likelihood of invasive management (adjusted odds ratio, 0.78 [95% CI, 0.75–0.81]; adjusted odds ratio, 0.72 [95% CI, 0.70–0.74]; P <0.001 for both). At eGFR levels ≥10, Black patients were significantly less likely than White patients to undergo invasive management. Conclusions: Black patients with MI and mild or moderate CKD were less likely to undergo invasive management compared with White patients with similar CKD severity. National efforts are needed to address racial disparities that may remain in the invasive management of MI.

Abstract 16910: High-Frequency In-Person Visits During Clinical Trial Enrollment is Associated With Relative Reduction in Event Rates in Heart Failure Patients Followed Longitudinally

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Liana C Brooks ◽  
Rohan R Bhat ◽  
Robyn F Farrell ◽  
Mark W Schoenike ◽  
John A Sbarbaro ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
High Frequency ◽  
Trial Participation ◽  
Trial Period ◽  
Single Center ◽  
Hospitalization Rates ◽  
Visit Frequency ◽  
Clinical Trial Enrollment ◽  
Event Rates

Introduction: The COVID-19 Pandemic has mandated limiting routine visit frequency for patients with chronic cardiovascular (CV) diseases. In patients with heart failure (HF) followed longitudinally, the period of clinical trial participation provides an opportunity to evaluate the influence of high-frequency per-protocol in-person visits compared to less frequent routine visits during longitudinal clinical care. Hypothesis: Patients enrolled in clinical trials will have a lower CV and HF event rates during periods of trial enrollment than during non-trial periods. Methods: We examined clinical characteristics, CV and HF hospitalization rates, and outcomes in patients with HF receiving longitudinal HF care at a single center. We evaluated hospitalization rates during the 1-year preceding trial enrollment and hospitalization and death rates during enrollment in clinical trials and for up to 1 year following trial completion. Results: Among the 121 patients enrolled in HF clinical trials, 72% were HFrEF (age 62±11, 19% females, BMI 30.4±6.0, LVEF 25±7, NYHA 2.7±0.6, NT-proBNP 2336±2671) and 28% were HFpEF (age 69±9, BMI 32.1±5.5, 29% females, LVEF 60±10, NYHA 2.4±0.5, NT-proBNP 957±997). Average clinical trial exposure was 8±6.6 months. Per-protocol visit frequency was 16±7 per year during clinical trial enrollment. In the one-year pre-trial period, compared to the within-trial period, CV hospitalizations were 0.88/patient-year vs. 0.32/patient-year (p<0.001) and HF hospitalizations were 0.63/patient-year and 0.24/patient-year (p<0.001), with a mortality rate of 0.04/patient-year during trial participation. In the period of up-to 1 year following the end of trial enrollment CV and HF hospitalizations were intermediate at 0.51/patient-year and 0.27/patient-year with an annualized incremental mortality rate of 0.03/patient-year. Conclusion: In HF patients followed longitudinally at a single center, periods of clinical trial enrollment were associated with high visit frequency and lower CV and HF hospitalization rates. These findings highlight the potential benefits of trial enrollment and high-frequency visits for HF patients at a time when routine visit frequency is being carefully considered during the COVID-19 Pandemic.

scholarly journals Dissecting racial bias in an algorithm used to manage the health of populations

Science ◽  
2019 ◽  
Vol 366 (6464) ◽  
pp. 447-453 ◽  
Author(s):  
Ziad Obermeyer ◽  
Brian Powers ◽  
Christine Vogeli ◽  
Sendhil Mullainathan
Keyword(s):  
Health Care ◽  
Racial Bias ◽  
Predictive Accuracy ◽  
Health Care Cost ◽  
Ground Truth ◽  
Racial Biases ◽  
Black Patients ◽  
Unequal Access ◽  
Care Costs ◽  
White Patients

Health systems rely on commercial prediction algorithms to identify and help patients with complex health needs. We show that a widely used algorithm, typical of this industry-wide approach and affecting millions of patients, exhibits significant racial bias: At a given risk score, Black patients are considerably sicker than White patients, as evidenced by signs of uncontrolled illnesses. Remedying this disparity would increase the percentage of Black patients receiving additional help from 17.7 to 46.5%. The bias arises because the algorithm predicts health care costs rather than illness, but unequal access to care means that we spend less money caring for Black patients than for White patients. Thus, despite health care cost appearing to be an effective proxy for health by some measures of predictive accuracy, large racial biases arise. We suggest that the choice of convenient, seemingly effective proxies for ground truth can be an important source of algorithmic bias in many contexts.

P003 INFLAMMATORY BOWEL DISEASE PATIENTS’ PERSPECTIVES OF CLINICAL TRIALS

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S53-S53
Author(s):  
David Rubin ◽  
Laurent Peyrin-Biroulet ◽  
Walter Reinisch ◽  
Swati Tole ◽  
Laura Sullivan ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Health Care Providers ◽  
Online Survey ◽  
The United States ◽  
Trial Participation ◽  
Pharmaceutical Manufacturer ◽  
Care Providers ◽  
Inflammatory Bowel

Abstract Background Despite recent progress in treatment for inflammatory bowel diseases (IBD), there is a need for therapies with long-term efficacy and improved safety. Clinical trials in IBD face challenges with patient recruitment because of study designs, competitive or overlapping trials, and a limited number of eligible patients. We sought to better understand patients’ motivations, awareness of, and experience with IBD clinical trials. Methods We conducted an international survey of adult patients with IBD consisting of 2 components. The quantitative component, a 15-minute online survey, was completed by all patients. A qualitative component, a 30-minute telephone interview, was completed by a subset of patients from the United States (US). All percentages indicate results from the online survey. Results 226 patients (mean age, 41.9 y) completed the online survey. Survey respondents included patients with ulcerative colitis (52%) and Crohn’s disease (48%) from the US (n=100, 21 of whom underwent a phone interview), Brazil (n=26), Canada (n=25), France (n=25), Germany (n=25), and Spain (n=25). Ninety-six percent of respondents reported at least a basic understanding of clinical trials, and 34 (15%) were current or past clinical trial participants. Patients reported learning about trials through 1 or more sources (could select as many as applied): health care providers (42%), pharmaceutical manufacturer websites (31%), social media (30%), online support groups (28%), and foundations (18%-23%). In the survey, patients rated conversations with health care providers most helpful, but patients who were interviewed revealed that most physicians often do not initiate conversations about clinical trials, and patients typically do not ask. Primary motivators for trial participation (rated from “does not encourage me at all” to “encourages me very much”) included altruistic goals of advancing medicine (67%), potentially mitigating risks of uncontrolled IBD such as colon cancer (59%), and access to treatment options that could improve quality of life (59%) or would otherwise be unaffordable (52%). Major barriers to participation (rated from “does not discourage me at all” to “discourages me very much”) included invasive screening and monitoring (35%), concern over receiving placebo (35%), or suboptimal treatment (33%), and concerns about posttrial access to study medication (27%). The majority (68%) reported that being in a clinical trial means being a “guinea pig” for an experimental treatment. Conclusion Opportunities to improve patients’ clinical trial experience in IBD include better communication with health care providers and improved patient education about clinical trial design and ethics. Ultimately, a better understanding of the patient perspective will be important for more informed patients and potentially higher recruitment and enrollment.

Cost analysis of a randomized trial of early palliative care (PC) in patients with metastatic non-small cell lung cancer (NSCLC).

2014 ◽  
Vol 32 (31_suppl) ◽  
pp. 4-4 ◽  
Author(s):  
Joseph A. Greer ◽  
Angela Tramontano ◽  
Pamela M McMahon ◽  
Areej El-Jawahri ◽  
Ravi Bharat Parikh ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Health Care Costs ◽  
Standard Care ◽  
Secondary Analysis ◽  
Cost Of Care ◽  
Average Total Cost ◽  
Total Cost ◽  
Metastatic Nsclc ◽  
Care Costs

4 Background: Several randomized, controlled trials have shown that early, integrated palliative and oncology care improves quality of life, mood, and symptom burden in patients with advanced cancers. However, the degree to which early involvement of specialty PC in the ambulatory care setting impacts the cost of care remains unknown. We investigated the health care costs for patients with metastatic NSCLC enrolled in a clinical trial of early PC. Methods: For this secondary analysis, we examined data from a randomized trial of 151 patients with newly-diagnosed metastatic NSCLC from 06/2006 to 07/2009. Patients received either early PC integrated with standard care or standard care (SC) alone. We abstracted costs for emergency and inpatient care, outpatient visits, intravenous chemotherapy, and physician services from the hospital’s accounting system. Oral chemotherapy costs were estimated based on actual drug charges for patients. To estimate hospice costs, we used Medicare reimbursement rates. For each participant, we calculated the average total cost of care per day for the entire study period as well as the total cost of care for the final 30 days prior to death. Costs differences between groups were examined with the Wilcoxon Rank-Sum Test. Results: We analyzed health care costs of the 138 patients who died by 07/15/2013 (early PC N=68; SC N=70). The mean number of days on study was longer for patients assigned to early PC (M=397, SD=360) versus SC (M=299, SD=266). Over the study period, early PC was associated with a lower average total cost per day of $117 (SD=$436) compared to SC (p=.09). In the final 30 days of life, patients in the early PC group incurred higher total costs for hospice care (Mean difference=$1,053, SD=$3,162, p=.11), while expenses for chemotherapy were less (Mean difference=$757, SD=$2,143, p=.06). No cost differences between groups met the threshold for statistical significance. Conclusions: Although this secondary analysis was inconclusive due to the lack of statistical power to examine differences in cost outcomes, the delivery of early PC for patients with metastatic NSCLC does not appear to increase health care expenses over the course of disease or at the end of life. Clinical trial information: NCT01038271.

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