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.

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.

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]

scholarly journals The Management of Older Adults with Pancreatic Adenocarcinoma

Geriatrics ◽  
2018 ◽  
Vol 3 (4) ◽  
pp. 85 ◽  
Author(s):  
John Ogden ◽  
Hao Xie ◽  
Wen Ma ◽  
Joleen Hubbard
Keyword(s):  
Older Adults ◽  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Treatment Options ◽  
Karnofsky Performance Score ◽  
Nccn Guidelines ◽  
The Us ◽  
Localized Disease ◽  
Clinical Trial Enrollment ◽  
Current Guidelines

Pancreatic cancer is the eleventh most common cancer, yet it is the third leading cause of mortality. It is also largely a disease of older adults, with the median age of 71 at diagnosis in the US, with <1% of diagnoses occurring prior to age 50. Current NCCN guidelines recommend surgery for localized disease, followed by adjuvant therapy and/or consideration of enrollment in a clinical trial. For metastatic disease, current guidelines recommend clinical trial enrollment or systemic chemotherapy based on results from the landmark ACCORD-11 and MPACT trials. However, these trials focused heavily on younger, more fit patients, with the ACCORD-11 trial excluding patients over age 75 and the MPACT trial having 92% of its patients with a Karnofsky performance score >80. This article summarizes the available evidence in current literature in regards to the best treatment options for older adults, who represent the majority of pancreatic cancer diagnoses.

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.

Feasibility of cancer clinical trial enrollment goals based on cancer incidence.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 20-20
Author(s):  
George Nhat Tran ◽  
Matthew Harker ◽  
Karen Chiswell ◽  
Joseph M. Unger ◽  
Mark Fleury ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cancer Diagnosis ◽  
Cancer Incidence ◽  
Recruitment Rate ◽  
Free Text ◽  
Medical Subject Headings ◽  
Cancer Society ◽  
The Us ◽  
Clinical Trial Enrollment ◽  
Suboptimal Design

20 Background: More than 20% of US clinical trials fail to accrue sufficient patients and terminate prematurely, impeding innovation and negating the valuable contributions of participating patients. The aim of this study is to estimate availability of patients for each trial opening in the national oncology clinical research portfolio to provide a benchmark for better understanding feasibility of clinical trial enrollment goals. Methods: The Database for Aggregate Analysis of ClinicalTrials.gov, up-to-date as of September 3, 2017, was used to identify actively-recruiting, interventional oncology trials at US sites. Observational studies were excluded as not all are registered. Trials were categorized via Medical Subject Headings or free text condition terms and sorted by cancer diagnosis. Trial slot availability was estimated between September 1, 2017, to August 31, 2018. Availability was estimated from total anticipated enrollment, assuming a constant recruitment rate. Estimates for studies with both foreign and US sites were pro-rated to calculate available enrollment in the US alone. The 2017 American Cancer Society cancer incidence estimates were used to approximate total US cancer diagnoses. Results: 4598 oncology trials were identified. Overall, an estimated 12.6 cancer patients are available for each clinical trial slot. The estimates by cancer diagnosis were: colorectal: 24.7 patients per trial slot; lung & bronchus: 20.1; prostate: 17.6; breast (female): 13.8; leukemia 11.6; and brain & other nervous system: 6.0. Conclusions: Across all diagnoses, 1 in 13 patients must enroll to meet accrual demands. This ratio varies by diagnosis. If cancer incidence is too low, trials with unrealistic accrual goals may be doomed at inception. In diagnoses with high disease burden, trial failure may be due to poor patient access or suboptimal design. [Table: see text]

Comparing two methods for delivering clinical trial informed consent information to older adults: singular versus stepped approach

2018 ◽  
Vol 15 (6) ◽  
pp. 610-615
Author(s):  
Fleur O’Hare ◽  
Zachary Flanagan ◽  
Mark Nelson ◽  
Andrea Curtis ◽  
Stephane Heritier ◽  
...  
Keyword(s):  
Older Adults ◽  
Clinical Trial ◽  
General Practice ◽  
Informed Consent ◽  
Informed Consent Process ◽  
Consent Process ◽  
Trial Participation ◽  
Delivery Method ◽  
Significant Difference ◽  
Baseline Screening

Background Adapting the informed consent process to the needs of older adults may enhance engagement and willingness to participate in a clinical trial. A key aspect of the process is being provided with written clinical trial information and consent documents and having an opportunity to discuss the information with the researcher. However, there are no guidelines on the most appropriate method for delivering this information to older adults and it is not known whether the delivery method is a facilitator or barrier towards clinical trial participation. Aims To compare two delivery methods of informed consent on recruitment, refusal to continue and randomisation rates in a general practice-based clinical trial involving older adults. Methods In a matched cohort sub-study as part of the STAtins in Reducing Events in the Elderly clinical trial, 520 participants were allocated into two groups by age, gender and attending general practice location, to receive the trial information and consent form in the mail (Method 1) prior to the first baseline visit or in person (Method 2) at the visit where a comprehensive informed consent process took place. Results Compared with Method 1, potential participants assigned to Method 2 were more likely to agree to attend the first baseline screening visit (refusal rate 20% vs 13.5%, respectively, p = 0.05). However, there was no significant difference in the proportion of participants recruited into the trial by providing written informed consent at the first baseline screening visit. For each informed consent delivery method, similar proportions of participants refused to take part in the trial by the end of the screening phase. Randomisation rates in the two groups were also similar. Time to conduct the informed consent procedure took significantly longer with Method 2 compared with Method 1 (median time 20 vs 15 min, respectively, p < 0.01). Interest in the research trial topic was the main reason cited (33.4%) for considering trial participation. Conclusion Later delivery of informed consent documents to potential participants in this trial was associated with a small increase in attendance at the first, in person, screening visit. However, the randomisation rate of participants into the trial was not affected by the method and timing of delivery of informed consent information. Similar randomisation rates occurred whether potential participants were mailed informed consent documents prior to the first in person screening visit or were given the information at the screening visit.

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]

Impact of organ function based standard exclusion criteria in diffuse large b-cell lymphoma (DLBCL) patients: Who gets left behind?

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14100-e14100
Author(s):  
Arushi Khurana ◽  
Raphael Mwangi ◽  
Grzegorz S. Nowakowski ◽  
Thomas Matthew Habermann ◽  
Stephen M. Ansell ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
B Cell Lymphoma ◽  
Standard Of Care ◽  
Trial Participation ◽  
Newly Diagnosed ◽  
Organ Function ◽  
Exclusion Criteria ◽  
The Us ◽  
The Impact

e14100 Background: Only 3-5% of adult cancer patients in the US enroll in clinical trials. Patients with organ dysfunction are often excluded from clinical trials, regardless of specific drug metabolism or relative function of the organ. The ASCO and the US FDA recommend modernizing criteria related to baseline organ function and comorbidities. In hematological malignancies, often the disease itself is the reason for organ function derangement. In order to better inform clinical trial eligibility and improve participation in the future, we evaluated the impact of baseline organ function on the potential eligibility for clinical trial enrollment for real world patients with newly diagnosed DLBCL. Methods: Consecutive, newly diagnosed lymphoma patients were offered enrollment from 2002-2015 into the Molecular Epidemiology Resource (MER) of the University of Iowa/Mayo Clinic Lymphoma Specialized Program of Research Excellence. This analysis is based on 1270 DLBCL patients receiving immunochemotherapy. Baseline organ function parameters were identified from the exclusion criteria for hemoglobin, absolute neutrophil count (ANC), platelet count, creatinine, and bilirubin reported in recent frontline trials in DLBCL (Table). Abstracted clinical labs from the MER were used to determine the percent of patients that would be excluded based on the criteria. Results: We determined that 11-23% of MER DLBCL patients receiving standard of care frontline therapy would have been excluded in the various trials utilizing baseline organ function alone (Table). Hemoglobin and renal function had the greatest impact on exclusion. Conclusions: Current national and international (phase II and III) trials are excluding up to 23% of patients from clinical trial participation based on organ function alone in DLBCL. These data will be useful in future clinical trial development to meet ASCO recommendations to increase trial accrual, while balancing the drug toxicities and patient safety. An online tool was developed based on these results to aid future trial development. [Table: see text]

No Evidence of Racial Disparities in Blood Pressure Salt Sensitivity When Potassium Intake Exceeds Levels Recommended in the US Dietary Guidelines

2021 ◽  
Author(s):  
Theodore W. Kurtz ◽  
Stephen E. DiCarlo ◽  
Michal Pravenec ◽  
R. Curtis Morris
Keyword(s):  
Blood Pressure ◽  
Racial Disparities ◽  
Racial Differences ◽  
Salt Intake ◽  
Salt Sensitivity ◽  
Dietary Guidelines ◽  
Potassium Intake ◽  
Dietary Potassium ◽  
The Us ◽  
The Impact

On average, black individuals are widely believed to be more sensitive than white individuals to blood pressure (BP) effects of changes in salt intake. However, few studies have directly compared the BP effects of changing salt intake in black versus white individuals. In this narrative review, we analyze those studies and note that when potassium intake substantially exceeds the recently recommended US dietary goal of 87 mmol/d, black adults do not appear more sensitive than white adults to BP effects of short-term or long-term increases in salt intake (from an intake ≤ 50 mmol/d up to 150 mmol/d or more). However, with lower potassium intakes, racial differences in salt sensitivity are observed. Mechanistic studies suggest that racial differences in salt sensitivity are related to differences in vascular resistance responses to changes in salt intake mediated by vasodilator and vasoconstrictor pathways. With respect to cause and prevention of racial disparities in salt sensitivity, it is noteworthy that 1) on average, black individuals consume less potassium than white individuals and 2) consuming supplemental potassium bicarbonate, or potassium rich foods can prevent racial disparities in salt-sensitivity. However, the new US Dietary Guidelines reduced the dietary potassium goal well-below the amount associated with preventing racial disparities in salt sensitivity. These observations should motivate research on the impact of the new dietary potassium guidelines on racial disparities in salt sensitivity, the risks and benefits of potassium-containing salt substitutes or supplements, and methods for increasing consumption of foods rich in nutrients that protect against salt-induced hypertension.

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