scholarly journals 1607P The impact of absolute neutrophil count on clinical trial participation in the United States

2020 ◽  
Vol 31 ◽  
pp. S967
Author(s):  
B. Adesunloye
2013 ◽  
Vol 31 (5) ◽  
pp. 536-542 ◽  
Author(s):  
Joseph M. Unger ◽  
Dawn L. Hershman ◽  
Kathy S. Albain ◽  
Carol M. Moinpour ◽  
Judith A. Petersen ◽  
...  

Purpose Studies have shown an association between socioeconomic status (SES) and quality of oncology care, but less is known about the impact of patient SES on clinical trial participation. Patients and Methods We assessed clinical trial participation patterns according to important SES (income, education) and demographic factors in a large sample of patients surveyed via an Internet-based treatment decision tool. Logistic regression, conditioning on type of cancer, was used. Attitudes toward clinical trials were assessed using prespecified items about treatment, treatment tolerability, convenience, and cost. Results From 2007 to 2011, 5,499 patients were successfully surveyed. Forty percent discussed clinical trials with their physician, 45% of discussions led to physician offers of clinical trial participation, and 51% of offers led to clinical trial participation. The overall clinical trial participation rate was 9%. In univariate models, older patients (P = .002) and patients with lower income (P = .001) and education (P = .02) were less likely to participate in clinical trials. In a multivariable model, income remained a statistically significant predictor of clinical trial participation (odds ratio, 0.73; 95% CI, 0.57 to 0.94; P = .01). Even in patients age ≥ 65 years, who have universal access to Medicare, lower income predicted lower trial participation. Cost concerns were much more evident among lower-income patients (P < .001). Conclusion Lower-income patients were less likely to participate in clinical trials, even when considering age group. A better understanding of why income is a barrier may help identify ways to make clinical trials better available to all patients and would increase the generalizability of clinical trial results across all income levels.


2021 ◽  
Vol 7 ◽  
pp. 205520762110676
Author(s):  
Shaohai Jiang ◽  
Y. Alicia Hong

Objective Public participation in a clinical trial is the foundation of clinical research and the cornerstone for the discovery of new treatment and improving health outcomes. This study aims to examine how eHealth engagement, patient–provider communication, and clinical trial knowledge are associated with clinical trial participation in the United States. Methods Data were drawn from the Health Information National Trends Survey Iteration 5 Cycle 4 conducted in 2020. The sample included 3865 American adults aged 18 years and above. Path analysis using structural equation modeling and hierarchical linear regression was performed to examine the effects of eHealth engagement and patient–provider communication on clinical trial participation. Results About 5% of American adults have ever participated in a clinical trial. Younger adults, males, minorities, and people with lower education, less clinical trial knowledge, and less eHealth engagement were less likely to participate. After controlling for demographic variables, we found that more eHealth engagement led to a better knowledge of clinical trials, which was strongly associated with participation. Further, patient-centered communication did not directly lead to clinical trial participation; instead, it positively moderated the relationship between clinical trial knowledge and participation. Conclusions The national survey data indicate that American participation in clinical trials remains low and a significant disparity exists. Within the context of the eHealth movement, it is critical to implement targeted interventions to improve clinical trial knowledge, address the digital divide, and enhance patient-centered communication.


2020 ◽  
Author(s):  
Eudocia Q Lee ◽  
Michael Weller ◽  
Joohee Sul ◽  
Stephen J Bagley ◽  
Solmaz Sahebjam ◽  
...  

Abstract Building on an initiative to enhance clinical trial participation involving the Society for Neuro-Oncology, the Response Assessment in Neuro-Oncology Working Group, patient advocacy groups, clinical trial cooperative groups, and other partners, we evaluate the impact of eligibility criteria and trial conduct on neuro-oncology clinical trial participation. Clinical trials often carry forward eligibility criteria from prior studies that may be overly restrictive and unnecessary and needlessly limit patient accrual. Inclusion and exclusion criteria should be evaluated based on the goals and design of the study and whether they impact patient safety and/or treatment efficacy. In addition, we evaluate clinical trial conduct as a barrier to accrual and discuss strategies to minimize such barriers for neuro-oncology trials.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6513-6513
Author(s):  
Garrett Young ◽  
Larry Edward Bilbrey ◽  
Edward Arrowsmith ◽  
L. Johnetta Blakely ◽  
Davey B. Daniel ◽  
...  

6513 Background: Clinical trials are critical for improving outcomes for patients with cancer. However, there is some concern from health insurers that clinical trial participation can increase total cost of care for cancer patients. We investigated the impact of clinical trial participation on total costs paid by Medicare during the OCM program in a large community-based practice. Methods: Tennessee Oncology (TO) is a community oncology practice comprising over 90 oncologists across 30 sites of care. We linked TO trial data and electronic medical record data with OCM data for episodes of care from 2016-2018. To assess the impact of trial participation on total cost relative to routine care, we created matched comparator groups for each OCM episode based on cancer type, metastatic status, number of comorbidities, performance status, and age. Patients with breast cancer receiving hormone therapy only were excluded. Absolute and percent cost differences between groups were calculated for episodes that had a comparator group size of five or greater. Differences in total cost for trial episodes were compared to non-trial episodes, and significance was assessed using the Mann–Whitney U test. We also studied the impact of trial participation on receipt of active treatment in the last 14 days of life (TxEOL), hospice use, and hospitalizations. Results: During the study period, 8,026 completed OCM episodes met study criteria. Patients were enrolled in a clinical trial for 459 of these episodes. On average, episodes during which patients were on trial cost $5,973 less than matched non-trial episodes (Table), independent of early versus late-phase trial. Most savings resulted from decreased drug costs. There were no differences in rates of TxEOL (15% vs. 14% p=1.0), rates of hospitalizations (31% vs. 30% p=0.54), or hospice use (52% vs. 62% p=0.08) between trial and non-trial episodes. Median difference from comparator group average cost was significantly lower for clinical trial episodes (-18% vs. -6%, p<0.01). Conclusions: In the community setting, total costs paid by Medicare for patients participating in clinical trials during OCM episodes were lower than costs for similar patients receiving routine care. Clinical trial participation did not adversely impact end-of-life care or likelihood of hospitalization. These findings suggest that patient participation in clinical trials does not increase total cost of care nor enhance financial risk to payers.[Table: see text]


2016 ◽  
Vol 21 (4) ◽  
pp. 467-474 ◽  
Author(s):  
Ryan D. Nipp ◽  
Hang Lee ◽  
Elizabeth Powell ◽  
Nicole E. Birrer ◽  
Emily Poles ◽  
...  

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