scholarly journals Colon Cancer: The Exclusion of Native Americans and Hispanics from Clinical Trials in the United States

2021 ◽  
Author(s):  
Joseph Angel De Soto
Keyword(s):  
United States ◽  
Clinical Trial ◽  
Colon Cancer ◽  
Clinical Trials ◽  
African Americans ◽  
Native Americans ◽  
The United States ◽  
Cancer Clinical Trial ◽  
Cancer Clinical Trials ◽  
Trial Participants

Abstract:Introduction: Each year there are 150,000 new cases of colon cancer in the United States. The chance of death for Hispanics and Native Americans who get colon cancer is much higher than whites even though both groups are much less likely to get colon cancer than whites. In this study, we look at the inclusion or exclusion of Hispanics and Native Americans from colon cancer clinical trials. Methods: In this retrospective study, 48 colon cancer clinical trials in the United States with an aggregate of 421,530 participants performed within the last ten years were selected at random. These clinical trials were evaluated for the inclusion and exclusion of minorities. Results: Though whites make up only 60.1% of the population they make up 89% of the colon cancer clinical trial participants. African Americans, and Hispanics who make up 13.4% and 18.5% of the population only made up 5.6% and 0.6% of the colon cancer clinical trial participants. Only two native Americans out of 421,530 colon cancer clinical trial participants could be identified. Conclusion: Colon Cancer Clinical trials have systematically excluded Hispanics and Native Americans while minimizing the participation of African Americans. This may be directly related to the increased death rates seen in these groups and provides evidence for the non-generalizability of colon cancer clinical trials.

scholarly journals The Underrepresentation of Minorities and Non-Generalizability of Breast Cancer Clinical Trials?

2021 ◽  
Author(s):  
Joseph Angel De Soto
Keyword(s):  
Breast Cancer ◽  
United States ◽  
Clinical Trials ◽  
African Americans ◽  
Native Americans ◽  
Ethnic Minorities ◽  
Minority Groups ◽  
The United States ◽  
Cancer Clinical Trials ◽  
High Death

Introduction This year 43,000 women will die from breast cancer in the United States. African Americans and Native Americans though less likely to get breast cancer, once diagnosed they are much more likely to die from breast cancer. This increased death rate may in part be due to the non-generalizability of breast cancer clinical trials. In this study, we evaluate the participation of ethnic minorities from breast cancer clinical trials. Methodology In this study, fifty-six breast cancer clinical trials completed in the last ten years in the United States were evaluated for the inclusion of ethnic minorities in the breast cancer clinical trials. Results Only 21% of breast cancer clinical trials include information on ethnicity in the methodology while only 7% provided any information on the effect or toxicity of the therapeutic intervention in minority groups while 100% report the results for Whites. Though Whites only make up 60.1% of the population, they were 87.5% of the clinical trial participants while African Americans were 6.2%, Hispanics 3.1%, Asians 2.9% and Native Americans were 0.2% of the participants. Conclusion Racial minorities have been underrepresented in breast cancer clinical trials which may contribute to unnecessarily high death rates in these groups while suggesting limited generalizability of breast cancer clinical trials.

scholarly journals The Systemic Exclusion of Native Americans from Cancer Clinical Trials.

2021 ◽  
Author(s):  
Joseph Angel De Soto ◽  
Gabriel Selassie ◽  
Gilberta Yazzie
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Native American ◽  
African Americans ◽  
Native Americans ◽  
Ethnic Minorities ◽  
Health Care Disparities ◽  
The United States ◽  
Cancer Clinical Trials ◽  
Unnecessary Death

Introduction: A major source of health care disparities derives from the underrepresentation of ethnic minorities in clinical trials. The inclusion of ethnic minorities is necessary to generalize the results in terms of efficacy and toxicology of medications in cancer treatment. Methodology: In this retrospective study, 80 cancer clinical trials with an aggregate of 278,470 participants performed within the last ten years were selected at random. The number of ethnic minorities participating and inclusion of them in the results were evaluated. Results: Only, 42.5% of cancer clinical trials reported the ethnic background of participants in their trials while even less 5% reported the efficacy or toxicology of the therapeutic intervention for ethnic minorities. Whites, Hispanics, African Americans, and Native Americans make up 60.1%, 18.5%, 13.4% and 1.5% of the population they made up 85.3%, 2.54%, 7.6% and 0.12% of the participants that reported ethnicity, respectively. Out of 278,470 participants in cancer clinicals trials only 133 (0.048%) could be identified as Native American . Conclusion: Native Americans were nearly completely excluded from cancer clinical trials. African Americans and Hispanics were greatly underrepresented. Cancer Clinical trials may not be generalizable and have been inherently racist in the United States. This has led to the unnecessary death and suffering of Native Americans from cancer.

Public Attitudes Toward Participation in Cancer Clinical Trials

2003 ◽  
Vol 21 (5) ◽  
pp. 830-835 ◽  
Author(s):  
Robert L. Comis ◽  
Jon D. Miller ◽  
Carolyn R. Aldigé ◽  
Linda Krebs ◽  
Ellen Stoval
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Public Attitudes ◽  
Adult Population ◽  
The United States ◽  
Cancer Clinical Trial ◽  
Cancer Clinical Trials ◽  
Large Numbers ◽  
Confirmatory Factor ◽  
National Probability Sample

Purpose: The objective of this study is to understand the attitudes of American adults toward participation in cancer clinical trials. Methods: A national probability sample of 1,000 adults aged 18 and older living in noninstitutional settings was interviewed by telephone by Harris Interactive during March and April 2000. One participant was selected from each household selected for the study. The resulting data were weighted to reflect the full adult population of the United States as reported in Current Population Reports. An Index of Participation in a Cancer Clinical Trial was computed, using a confirmatory factor analysis and converting the factor scores into a 0-to-100 scale. Results: Approximately 32% of American adults (64 million individuals) indicate that they would be very willing to participate in a cancer clinical trial if asked to do so. An additional 38% of adults (76 million individuals) scored in a range that indicates that they are inclined to participate in a cancer clinical trial if asked, but hold some questions or reservations about participation. Projected rates of diagnosis, eligibility, and recruitment indicate that substantially more patients are willing to participate than are actually accrued. Conclusion: These results indicate that the primary problem with accrual is not the attitudes of patients, but rather that the loss of potential participants is the result of the unavailability of an appropriate clinical trial and the disqualification of large numbers of patients. The pool of willing patients is further reduced by the reluctance of some physicians to engage in accrual.

Pancreatic Cancer Clinical Trials and Accrual in the United States

2013 ◽  
Vol 31 (27) ◽  
pp. 3432-3438 ◽  
Author(s):  
William A. Hoos ◽  
Porsha M. James ◽  
Lola Rahib ◽  
Anitra W. Talley ◽  
Julie M. Fleshman ◽  
...  
Keyword(s):  
United States ◽  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Supply And Demand ◽  
The United States ◽  
Disease Stage ◽  
Ductal Adenocarcinoma ◽  
Cancer Clinical Trials ◽  
Cancer Trials

Purpose Pancreatic cancer clinical trials open in the United States and their accrual were examined to identify opportunities to accelerate progress in the treatment of pancreatic cancer. Methods Pancreatic cancer–specific clinical trials open in the United States in the years 2011 and 2012 were obtained from the Pancreatic Cancer Action Network database. Accrual information was obtained from trial sponsors. Results The portfolio of pancreatic cancer clinical trials identified by type (adenocarcinoma or neuroendocrine), phase, disease stage, and treatment approach is reported. More than half of trials for patients with pancreatic ductal adenocarcinoma applied biologic insights to new therapeutic approaches, and 38% focused on optimization of radiation or chemotherapy delivery or regimens. In 2011, pancreatic cancer trials required total enrollment of 11,786 patients. Actual accrual to 93.2% of trials was 1,804 patients, an estimated 4.57% of the patients with pancreatic cancer alive in that year. The greatest need was for patients with resectable cancer. Trials open in 2011 enrolled an average of 15% of their total target accrual. Physician recommendations greatly influenced patients' decision to enroll or not enroll onto a clinical trial. Matching to a clinical trial within a 50-mile radius and identifying trials for recurrent/refractory disease were documented as challenges for patient accrual. Conclusion Overall trial enrollment indicates that pancreatic cancer trials open in 2011 would require 6.7 years on average to complete accrual. These results suggest that harmonizing patient supply and demand for clinical trials is required to accelerate progress toward improving survival in pancreatic cancer.

scholarly journals Colon Cancer: The Exclusion of Native Americans and Hispanics from Clinical Trials in the United States

2021 ◽  
Vol 5 (9) ◽  
pp. 99-104
Author(s):  
Yazzie GA ◽  
Cayatineto HW ◽  
Clyde CS ◽  
Grunther B ◽  
de Soto JA
Keyword(s):  
United States ◽  
Colon Cancer ◽  
Clinical Trials ◽  
Native Americans ◽  
The United States

Trends in the geographic distribution of cancer clinical trials in the US: 2008-2015.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6515-6515
Author(s):  
Caroline Savage Bennette ◽  
Wei-Jhih Wang ◽  
Scott David Ramsey ◽  
Jean A. McDougall
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Geographic Distribution ◽  
Gini Coefficient ◽  
The United States ◽  
Cancer Clinical Trial ◽  
Cancer Clinical Trials ◽  
Hospital Service ◽  
The Gini Coefficient ◽  
The Us

6515 Background: Access to and patient enrollment in cancer clinical trials is likely strongly impacted by where trial enrollment sites are located. Our objective was to evaluate temporal trends in the geographic location of cancer clinical trials launched in the US. Methods: We obtained the recruiting location(s) of all public- and privately-funded phase II/ III cancer clinical trials launched in the US between 2008 and 2015 from the ClinicalTrials.gov database. We linked the recruiting location(s) of each trial to the relevant hospital service area (HSA), which are defined by ZIP codes as local health care markets for hospital care (n = 3436). We estimated the number of cancer clinical trial sites in each HSA each year between 2008 and 2015. We also calculated a statistical measure of inequality, the Gini coefficient. The Gini coefficient would be 0 if all hospital service areas launched the same number of cancer clinical trials, and would be 1 if all cancer clinical trials were launched in only a single hospital service area. Results: 62% of HSAs (n = 2133) did not launch a single cancer clinical trial between 2008 and 2015. There was a small and non-statistically significant decline in the overall number of cancer clinical trial sites in the United States between 2008 and 2015 (-1.6% per year [95% CI: -4.0, 0.9]). During this same period of time, however, inequality in the geographic distribution of cancer clinical trial sites considerably deepened. For example, in 2008-09, no trials were launched in 68% of HSAs while 19% of trial sites were in only 1% of HSAs. Trials launched in 2014-15 were even more concentrated: no new trials were launched in 74% of HSAs while 25% of trial sites were in the top 1% of HSAs. The Gini coefficient increased significantly from 0.683 (95% CI: 0.666, 0.700) for trials launched in 2008-09 to 0.726 (95% CI: 0.706, 0.746) for those launched in 2014-15. Conclusions: Our findings indicate increased inequality in the geographic distribution of cancer clinical trials launched in the United States since 2008. The underlying causes and consequences of such increasing concentration warrant further analysis given the importance in ensuring equitable geographic access to cancer clinical trials in the US.

Enrollment disparities in cancer clinical trials leading to FDA approvals between 2008 and 2020.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18501-e18501
Author(s):  
Ryan Huu-Tuan Nguyen ◽  
Yomaira Silva ◽  
Vijayakrishna K. Gadi
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Clinical Trials ◽  
Drug Approval ◽  
The United States ◽  
Cancer Clinical Trials ◽  
Cancer Prevalence ◽  
Fda Approval ◽  
The Us ◽  
Enrollment Data

e18501 Background: Cancer clinical trials based in the United States (US) have lacked adequate representation of racial and ethnic minorities, the elderly, and women. Pivotal clinical trials leading to United States Food and Drug Administration (FDA) approval are often multi-national trials and may also lack generalizability to underrepresented populations in the United States. We determined the racial, ethnic, age, and sex enrollment in pivotal trials relative to the US cancer population. Methods: We reviewed the FDA’s Drug Approvals and Databases for novel and new use drug approvals for breast, colorectal, lung, and prostate cancer indications from 2008 through 2020. Drugs@FDA was searched for drug approval summaries and FDA labels to identify clinical trials used to justify clinical efficacy that led to FDA approval. For eligible trials, enrollment data were obtained from FDA approval summaries, FDA labels, ClinicalTrials.gov, and corresponding journal manuscripts. Enrollment Fraction (EF) was calculated as enrollment in identified clinical trials divided by 2017 SEER cancer prevalence. All data sources were publicly available. Results: From 2008 through 2020, 60 drugs received novel or new use drug approval for breast, colorectal, lung, or prostate cancer indications based on 66 clinical trials with a total enrollment of 36,830. North America accounted for 9,259 (31%) enrollees of the 73% of trials reporting location of enrollment. Racial demographics were reported in 78% of manuscripts, 66% of ClinicalTrials.gov pages, and 98% of FDA labels or approval summaries. Compared with a 0.4% enrollment fraction among White patients, lower enrollment fractions were noted in Hispanic (0.2%, odds ratio [OR] vs White, 0.46; 95% confidence interval [CI], 0.43 to 0.49, P< 0.001) and Black (0.1%, OR 0.29; 95% CI 0.28 to 0.31, P< 0.001) patients. Elderly patients (age ≥ 65 years) were less likely than younger patients to be enrollees (EF 0.3% vs 0.9%, OR 0.27; 95% CI 0.26 to 0.27, P< 0.001) despite accounting for 61.3% of cancer prevalence. For colorectal and lung cancer trials, females were less likely than males (EF 0.7% vs 1.1%, OR 0.66; 95% CI 0.63 to 0.68, P< 0.001) to be enrolled. Conclusions: Black, Hispanic, elderly, and female patients were less likely to enroll in cancer clinical trials leading to FDA approvals from 2008 to 2020. Race and geographic enrollment data were inconsistently reported in journal manuscripts and ClinicalTrials.gov. The lack of appropriate representation of specific patient populations in these key clinical trials limits their generalizability. Future efforts must be made to ensure equitable access, representation, and reporting of enrollees that adequately represent the US population of patients with cancer.

Practical Aspects of Implementing and Applying Health Care Cloud Computing Services and Informatics to Cancer Clinical Trial Data

2021 ◽  
pp. 826-832
Author(s):  
Jay G. Ronquillo ◽  
William T. Lester
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Cancer Research ◽  
Cloud Computing ◽  
Clinical Trials ◽  
Laboratory Tests ◽  
Cancer Clinical Trial ◽  
Cancer Clinical Trials ◽  
Precision Oncology ◽  
Oncology Research

PURPOSE Cloud computing has led to dramatic growth in the volume, variety, and velocity of cancer data. However, cloud platforms and services present new challenges for cancer research, particularly in understanding the practical tradeoffs between cloud performance, cost, and complexity. The goal of this study was to describe the practical challenges when using a cloud-based service to improve the cancer clinical trial matching process. METHODS We collected information for all interventional cancer clinical trials from ClinicalTrials.gov and used the Google Cloud Healthcare Natural Language Application Programming Interface (API) to analyze clinical trial Title and Eligibility Criteria text. An informatics pipeline leveraging interoperability standards summarized the distribution of cancer clinical trials, genes, laboratory tests, and medications extracted from cloud-based entity analysis. RESULTS There were a total of 38,851 cancer-related clinical trials found in this study, with the distribution of cancer categories extracted from Title text significantly different than in ClinicalTrials.gov ( P < .001). Cloud-based entity analysis of clinical trial criteria identified a total of 949 genes, 1,782 laboratory tests, 2,086 medications, and 4,902 National Cancer Institute Thesaurus terms, with estimated detection accuracies ranging from 12.8% to 89.9%. A total of 77,702 API calls processed an estimated 167,179 text records, which took a total of 1,979 processing-minutes (33.0 processing-hours), or approximately 1.5 seconds per API call. CONCLUSION Current general-purpose cloud health care tools—like the Google service in this study—should not be used for automated clinical trial matching unless they can perform effective extraction and classification of the clinical, genetic, and medication concepts central to precision oncology research. A strong understanding of the practical aspects of cloud computing will help researchers effectively navigate the vast data ecosystems in cancer research.

scholarly journals Epidemiology and Factors Affecting Mortality of Hospitalized Patients with Disseminated Intravascular Coagulation in the United States

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2404-2404
Author(s):  
Arya Mariam Roy ◽  
Manojna Konda ◽  
Akshay Goel ◽  
Appalanaidu Sasapu
Keyword(s):  
United States ◽  
African Americans ◽  
Native Americans ◽  
Mortality Rate ◽  
Length Of Stay ◽  
Disseminated Intravascular Coagulation ◽  
The United States ◽  
Hospitalized Patients ◽  
Northeast Region ◽  
Intravascular Coagulation

Introduction Disseminated Intravascular Coagulation (DIC) is a systemic coagulopathy which leads to widespread thrombosis and hemorrhage and ultimately results in multiorgan dysfunction. DIC usually occurs as a complication of illnesses like severe sepsis, malignancies, trauma, acute pancreatitis, burns, and obstetrical complications. The prognosis and mortality of DIC depend on the etiology, however, the mortality of DIC is known to be on the higher side. The aim of the study is to analyze if gender, race, regional differences have any association with the mortality of hospitalized patients with DIC. Method The National Inpatient Sample database from the Healthcare Cost and Utilization Project (HCUP) for the year 2016 was queried for data. We identified hospital admissions for DIC with the International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis code D65. The data was analyzed with STATA 16.0 version and univariate and multivariate analysis were performed. We studied the characteristics of all such hospitalizations for the year 2016 and the factors associated with the in-hospital mortality rate (MR) of DIC. We used length of stay, cost of stay as an outcome to determine if gender, race, and location play a role in the mortality. Results A total of 8704 admissions were identified with a diagnosis of DIC during the year 2016. The mean age for admission was found to be 56.48± 0.22. The percentage of admissions in females and males did not have a notable difference (50.57% vs 49.43%). The disease specific MR for DIC was 47.7%. Admission during weekend vs weekdays did not carry a statistically significant difference in terms of MR. Females with DIC were less likely to die in the hospital when compared to males with DIC (OR= 0.906, CI 0.82 - 0.99, p= 0.031). Interestingly, African Americans (AA) with DIC admissions were found to have 24% more risk of dying when compared to Caucasians admitted with DIC (OR= 1.24, CI 1.10 - 1.39, P= 0.00), Native Americans (NA) has 67% more risk of dying when compared to Caucasians (OR= 1.67, CI 1.03 - 2.69, p= 0.035). The mortality rate of NA, AA, Caucasians with DIC was found to be 57%, 52%, 47% respectively. The MR was found to be highest in hospitals of the northeast region (52%), then hospitals in the south (47%), followed by west and mid-west (46%), p= 0.000. Patients admitted to west and mid-west were 24% less likely to die when compared to patients admitted to northeast region hospitals (OR= 0.76, p= 0.001). The average length of stay and cost of stay were also less in west and mid-west regions when compared to north east. The difference in outcomes persisted after adjusting for age, gender, race, hospital division, co-morbid conditions. Conclusion Our study demonstrated that African Americans and Native Americans with DIC have high risk of dying in the hospital. Also, there exists a difference between the mortality rate, length and cost of stay among different regions in the United States. More research is needed to elucidate the factors that might be impacting the location-based variation in mortality. Disclosures No relevant conflicts of interest to declare.

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