Comparative analysis of breast and lung cancer survival rates and clinical trial enrollments among rural and urban patients in Georgia.

Objectives: Rural patients have poor cancer outcomes and clinical trial (CT) enrollment compared to urban patients due to attitudinal, awareness, and healthcare access differential. Knowledge of cancer survival disparities and CT enrollment is important for designing interventions and innovative approaches to address the stated barriers. The study explores the potential disparities in cancer survival rates and clinical trial enrollments in rural and urban breast and lung cancer patients. Our hypotheses are that for both cancer types, urban cancer patients will have longer 5-year survival rates and higher enrollment rates in clinical trials than those in rural counties. Methods: We compared breast and lung cancer patients' survival rates and enrollment ratios in clinical trials between rural (RUCC 4-9) and urban counties in Georgia at a Comprehensive Cancer Center (CCC). To assess these differences, we carried out a series of independent samples t-tests and Chi-Square tests. Results: The outcomes indicate comparable 5-year survival rates across rural and urban counties for breast and lung cancer patients, failing to substantiate our hypothesis. While clinical trial enrollment rates demonstrated a significant difference between breast and lung cancer patients at CCC, no significant variation was observed based on rural or urban classification. Conclusion: These findings underscore the need for further research into the representation of rural patients with diverse cancer types at CCC and other cancer centers. Further, the findings have considerable implications for the initiation of positive social change to improve CT participation and reduce cancer survival disparities.

Improving clinical trial enrollment in minority racial and ethnic patients with gynecologic malignancy.

Purpose: Racial and ethnic minorities remain underrepresented in clinical trials . Underrepresentation of racial groups leads to the selection of therapeutic interventions that may not be representative of the population expected to use the medicine. This study evaluates the effectiveness of a set of implementation strategies to increase underrepresented patients in gynecologic cancer clinical trials. Methods: An interrupted time series analysis evaluating implementation strategies (pre-screening and fast-track referral) was conducted from January 2021 to May 2022. Descriptive analysis of gynecologic oncology patient screening and accrual was compared before and after intervention implementation. Results: During the study period (pre- and post-intervention), 26 patients were screened, and 9 patients enrolled in therapeutic gynecologic cancer clinical trials. Prior to the intervention, 7 patients were screened and 2 patients enrolled onto a clinical trial. Following the intervention, 19 patients were screened and 7 patients enrolled in a cancer clinical trial. Black patients comprised 13 of 19 (68.4%) of patients post-intervention compared to 1 of 7 (14.3 %) of patients screened pre-intervention (p < 0.05). All 7 patients enrolled post intervention were racial and ethnic minorities (non-Hispanic Black [4 of 7] and Hispanic White [3 of 7]) compared to no minority patients enrolled pre-intervention (p < 0.05). Screening increased 2.5-fold for all patients, and 5- fold for minority patients. Clinical trial enrollment increased 3.5-fold following intervention. Conclusions: A combination of pre-screening and fast-track referral intervention in a racial and ethnically diverse urban academic hospital was associated with a significant increase in minority screening and enrollment. Structured strategies to overcome barriers to underrepresented racial and ethnic patient accrual in academic hospitals are urgently warranted.

Evaluating enrollment and representation in COVID-19 and HIV vaccine clinical trials.

Background: Vaccine clinical trials should strive to recruit a racially, socioeconomically, and ethnically diverse range of participants to ensure appropriate representation that matches population characteristics. Yet, full inclusion in research is often limited. Methods: A single-center retrospective study was conducted of adults enrolled at Brigham and Women's Hospital (Boston, MA) between July 2020 and December 2021. Demographic characteristics, including age, race, ethnicity, ZIP code, and sex assigned at birth, were analyzed from both HIV and COVID-19 vaccine trials during the study period, acknowledging the limitations to representation under these parameters. We compared the educational attainment of vaccine trial participants to residents of the Massachusetts metropolitan area, geocoded participants' addresses to their census block group, and linked them to reported median household income levels from publicly available data for 2020. Frequency and quartile analyses were carried out, and spatial analyses were performed using ArcGIS Online web-based mapping software (Esri). Results: A total of 1030 participants from four COVID-19 vaccine trials (n = 916 participants) and six HIV vaccine trials (n = 114 participants) were included in the analysis. The median age was 49 years (IQR 33-63) and 28 years (IQR 24-34) for the COVID-19 and HIV vaccine trials, respectively. Participants identifying as White were the majority group represented for both the COVID-19 (n = 598, 65.3%) and HIV vaccine trials (n = 83, 72.8%). Fewer than 25% of participants identified as Hispanic or Latin. Based on ZIP code of residence, the median household income for COVID-19 vaccine clinical trial participants (n = 846) was 102,088 USD (IQR = 81,442-126,094). For HIV vaccine clinical trial participants (n = 109), the median household income was 101,266 USD (IQR 75,052-108,832). Conclusion: We described the characteristics of participants enrolled for HIV and COVID-19 vaccine trials at a single center and found similitude in geographical distribution, median incomes, and proportion of underrepresented individuals between the two types of vaccine candidate trials. Further outreach efforts are needed to ensure the inclusion of individuals from lower educational and socioeconomic brackets. In addition, continued and sustained efforts are necessary to ensure inclusion of individuals from diverse racial and ethnic backgrounds.

Variation in outcomes and practice patterns among patients with localized pancreatic cancer: the impact of the pancreatic cancer multidisciplinary clinic.

Introduction: Patients with localized pancreatic adenocarcinoma (PDAC) benefit from multi-modality therapy. Whether care patterns and oncologic outcomes vary if a patient was seen through a pancreatic multi-disciplinary clinic (PMDC) versus only individual specialty clinics is unclear. Methods: Using institutional Pancreatic Cancer Registry, we identified patients with localized PDAC from 2019- 2022 who eventually underwent resection. It was our standard practice for borderline resectable (BRPC) patients to undergo ≤4 months of neoadjuvant chemotherapy, ± radiation, followed by exploration, while locally advanced (LAPC) patients were treated with 4-6 months of chemotherapy, followed by radiation and potential exploration. Descriptive and multivariable analyses (MVA) were performed to examine the association between clinic type (PMDC vs individual specialty clinics i.e. surgical oncology, medical oncology, or radiation oncology) and study outcomes. Results: A total of 416 patients met inclusion criteria. Of these, 267 (64.2%) had PMDC visits. PMDC group received radiation therapy more commonly (53.9% versus 27.5%, p=0.001), as compared to individual specialty clinic group. Completion of neoadjuvant treatment (NAT) was far more frequent in patients seen through PMDC compared to patients seen through individual specialty clinics (69.3% vs 48.9%). On MVA, PMDC group was significantly associated with receipt of NAT per institutional standards (adjusted OR 2.23, 95% CI 1.46-7.07, p=0.006). Moreover, the average treatment effect of PMDC on progression-free survival (PFS) was 4.45 (95CI: 0.87-8.03) months. No significant association between overall survival (OS) and clinic type was observed. Discussion: Provision of care through PMDC was associated with significantly higher odds of completing NAT per institutional standards as compared to individual specialty clinics, which possibly translated into improved PFS. The development of multidisciplinary clinics for management of pancreatic cancer should be incentivized, and any barriers to such development should be addressed.

Enrollment of Black, Indigenous and People of Color (BIPOC) and female participants in the US diabetes trials spanning 2000 to 2020: A chronological survey.

AIMS: Little is known about the enrollment practice of both Black, Indigenous and People of Color (BIPOC) and females in the US diabetes trials. We aimed to perform a chronological survey to evaluate the enrollment of BIPOC and female participants in the US diabetes randomized controlled trials (RCTs) over the past two decades. METHODS: We searched databases to systematically include the US diabetes RCTs from 2000 January 1st to 2020 December 31st. Primary outcome was the adequate enrollment of both BIPOC and females, defined by the participation to prevalence ratio (PPR) > 0.8. We tested the temporal trend in adequate enrollment over time and used logistic regression analysis to explore the relationship between adequate enrollment and trial characteristics. RESULTS: A total of 69 US diabetes trials were included for analyses, with a median BIPOC and female enrollment percentage of 29.0 % and 45.4 % respectively. There were 22 (31.9 %) trials with adequate enrollment of both BIPOC and females. No significant trend of adequate enrollment percentage of BIPOC and females over time was observed (P = 0.16). Of trial types, those with medication interventions were significantly related to decreased odds of adequate enrollment, when compared to trials with non-drug interventions (odds ratio = 0.29, 95 % confidence interval: 0.11-0.84). CONCLUSIONS: Less than one third of the US diabetes trials adequately enrolled both BIPOC and females over the past two decades, and no temporal improvement in BIPOC and female participant enrollment was observed. These results highlight the need for more endeavors to mitigate inadequate representation regarding BIPOC and female enrollment in diabetes trials.

Utilizing Large Language Models for Enhanced Clinical Trial Matching: A Study on Automation in Patient Screening.

Background Clinical trial matching, essential for advancing medical research, involves detailed screening of potential participants to ensure alignment with specific trial requirements. Research staff face challenges due to the high volume of eligible patients and the complexity of varying eligibility criteria. The traditional manual process, both time-consuming and error-prone, often leads to missed opportunities. Recently, large language models (LLMs), specifically generative pre-trained transformers (GPTs), have become impressive and impactful tools. Utilizing such tools from artificial intelligence (AI) and natural language processing (NLP) may enhance the accuracy and efficiency of this process through automated patient screening against established criteria. Methods Utilizing data from the National NLP Clinical Challenges (n2c2) 2018 Challenge, we utilized 202 longitudinal patient records. These records were annotated by medical professionals and evaluated against 13 selection criteria encompassing various health assessments. Our approach involved embedding medical documents into a vector database to determine relevant document sections and then using an LLM (OpenAI's GPT-3.5 Turbo and GPT-4) in tandem with structured and chain-of-thought prompting techniques for systematic document assessment against the criteria. Misclassified criteria were also examined to identify classification challenges. Results This study achieved an accuracy of 0.81, sensitivity of 0.80, specificity of 0.82, and a micro F1 score of 0.79 using GPT-3.5 Turbo, and an accuracy of 0.87, sensitivity of 0.85, specificity of 0.89, and micro F1 score of 0.86 using GPT-4. Notably, some criteria in the ground truth appeared mislabeled, an issue we couldn't explore further due to insufficient label generation guidelines on the website. Conclusion Our findings underscore the potential of AI and NLP technologies, including LLMs, in the clinical trial matching process. The study demonstrated strong capabilities in identifying eligible patients and minimizing false inclusions. Such automated systems promise to alleviate the workload of research staff and improve clinical trial enrollment, thus accelerating the process and enhancing the overall feasibility of clinical research. Further work is needed to determine the potential of this approach when implemented on real clinical data.

Disparities in clinical trial enrollment among patients with gastrointestinal cancer relative to minority-serving and safety-netting hospitals.

BACKGROUND: For results to be generalizable to all patients with cancer, clinical trials need to include a diverse patient demographic that is representative of the general population. We sought to characterize the effect of receiving care at a minority-serving hospital (MSH) and/or safety-net hospital on clinical trial enrollment among patients with gastrointestinal (GI) malignancies. METHODS: Adult patients with GI cancer who underwent oncologic surgery and were enrolled in institutional-/National Cancer Institute-funded clinical trials between 2012 and 2019 were identified in the National Cancer Database. Multivariable regression was used to assess the relationship between MSH and safety-net status relative to clinical trial enrollment. RESULTS: Among 1,112,594 patients, 994,598 (89.4%) were treated at a non-MSH, whereas 117,996 (10.6%) were treated at an MSH. Only 1857 patients (0.2%) were enrolled in a clinical trial; most patients received care at a non-MSH (1794 [96.6%]). On multivariable analysis, the odds of enrollment in a clinical trial were markedly lower among patients treated at an MSH vs non-MSH (odds ratio [OR], 0.32; 95% CI, 0.22-0.46). In addition, even after controlling for receipt of care at MSH, Black patients remained at lower odds of enrollment in a clinical trial than White patients (OR, 0.57; 95% CI, 0.45-0.73; both P < .05). CONCLUSION: Overall, clinical trial participation among patients with GI cancer was extremely low. Patients treated at an MSH and high safety-net burden hospitals and Black individuals were much less likely to be enrolled in a clinical trial. Efforts should be made to improve trial enrollment and address disparities in trial representation.

Strengths and opportunities to clinical trial enrollment among BIPOC, rural dwelling patients in the northwest United States: a retrospective study.

Introduction: Clinical trials investigating the safety and efficacy of experimental drugs and devices are the cornerstone of medicinal advancement. Enrolling sufficient participants in these trials is vital to ensure adequate statistical power and generalizability. Clinical trial participation is particularly low among certain populations, including medically underserved communities (i.e., rural areas) and Black, Indigenous, and People of Color (BIPOC). Methods: A retrospective study design was used to understand patient outcomes and access/barriers to clinical trial participation in the rural northwest United States. A quantitatively focused retrospective chart review was conducted for adult participants enrolled in at least one clinical trial in a single northwest health system between 1999 and 2022. Descriptive and inferential statistical analyses were performed to assess trial outcomes at a significance level 0.05. Results: The retrospective chart review yielded 833 clinical trial records with 753 individual enrolled participants. The all-cause relative frequency of death at last known follow-up amongst clinical trial participants was 8.90% (n = 67). Based on logistic regression, the death was significantly associated with the participants' age at initial trial screening (ß = 0.09, p-value <0.001), those that resided in non-metro areas (ß = -0.86, p-value = 0.045), and those that lived in Northeastern Montana (ß = 1.27, p-value = 0.025). Additionally, death at last known follow-up was significantly associated with enrollment in 2021-2022 (ß = -1.52, p-value <0.001), enrolled in more than one study (ß = 0.84, p-value = 0.023), in internationally sponsored trials (ß = -2.08, p-value <0.001), in Phase I (ß = 5.34, p-value <0.001), in Phase II trials (ß = 1.37, p-value = 0.013), diabetes as a primary trial target (ß = -2.04, p-value = 0.003). Conclusion: As decentralized trial design and remote or virtual elements of traditional trials become normative, representation of rural and frontier populations is imperative to support the generalizability of trial data encouraged by the FDA.

How far is too far? Cancer prevention and clinical trial enrollment in geographically underserved patient populations.

Despite dedicated efforts to improve equitable access to cancer care in the United States, disparities in cancer outcomes persist, and geographically underserved patients remain at an increased risk of cancer with lower rates of survival. The critical evaluation of cancer prevention inequities and clinical trial access presents the opportunity to outline novel strategies to incrementally improve bookended access to gynecologic cancer care for geographically underserved patients. Cancer prevention strategies that can be addressed in the rural patient population mirror priorities in the Healthy People 2030 objectives and include increased identification of high risk individuals who may benefit from increased cancer screening and risk reduction, increasing the proportion of people who discuss interventions to prevent cancer, such as HPV vaccination, with their provider, and increasing the proportion of adults who complete evidence based cancer screening. Barriers to accrual to clinical trials for rural patients overlap significantly with the same barriers to obtaining health care in general. These barriers include: lack of facilities and specialized providers; lack of robust health infrastructure; inability to travel; and financial barriers. In this review, we will discuss current knowledge and opportunities to improve cancer prevention initiatives and clinical trial enrollment in geographically underserved populations with a focus on rurality.

Alliance A151945: Accrual and characteristics of adolescent and young adult patients in Alliance trials from 2000 to 2017.

BACKGROUND: Identifying patient- and disease-specific characteristics associated with clinical trial enrollment of adolescents and young adults (AYAs) with cancer may target efforts to improve accrual. METHODS: Alliance for Clinical Trials in Oncology (Alliance) trials opened from January 1, 2000, and closed before January 1, 2018, for common AYA cancers were identified. Proportions of AYAs (aged 18-39 years old) versus non-AYAs (aged ≥40 years old) enrolled by cancer type were summarized by descriptive statistics. Among studies with ≥20 AYAs enrolled, demographic and disease characteristics of AYAs versus non-AYAs were compared with χ2 and Kruskal-Wallis tests. A qualitative review was also conducted of therapeutic trials included in analysis in PubMed through December 31, 2021, that reported AYA-specific survival. RESULTS: Among 188 trials enrolling 40,396 patients, AYAs represented 11% (4468 of 40,396) of accrual. AYA accrual varied by cancer type (leukemia, 23.6%; breast, 9.9%; lymphoma, 14.8%; colorectal, 6.2%; central nervous system, 8.1%; melanoma, 11.8%; sarcoma, 12%). Across ages, the proportion of Black and Hispanic patients enrolled was 1%-10%. Compared to non-AYAs, AYAs in breast and colorectal cancer trials were less likely to be White and more likely to be Hispanic. Disease characteristics differed by age for selected trials. Two trials reported AYA-specific survival, with no significant differences observed by age. CONCLUSIONS: AYA accrual to Alliance trials was comparable to or exceeded population-based, age-specific prevalence estimates for most cancer types. Greater proportional representation of Hispanic and non-White patients among AYAs reflects US demographic trends. The small number of minority patients enrolled across ages underscores the persistent challenge of ensuring equitable access to trials, including for AYAs.

National enrollment of lung cancer clinical trials is disproportionate based on race and health care access.

OBJECTIVE: Despite declining lung cancer mortality in the United States, survival differences remain among racial and ethnic minorities in addition to those with limited health care access. Improvements in lung cancer treatment can be obtained through clinical trials, yet there are disparities in clinical trial enrollment of other cancer types. This study aims to evaluate disparities in lung cancer clinical trial enrollment to inform future enrollment initiatives. METHODS: We analyzed patients with non-small cell lung cancer from the National Cancer Database (2004-2018), categorizing them as enrolled or not enrolled in clinical trials based on "rx_summ_other" data element. Clinical, demographic, and institutional factors associated with trial enrollment were assessed using bivariate and multivariate analysis, adjusting for institutional-level clustering. RESULTS: A total of 1924 (0.12%) patients with lung cancer were enrolled in clinical trials. Enrolled patients were predominantly non-Hispanic White (82%), with greater socioeconomic status, treated at academic programs (67%), and had private insurance (42%) or Medicare (44%). They also traveled further for treatment compared with unenrolled patients (56 vs 27 miles, P < .001). After adjusting for demographic and clinical factors, lung cancer trial enrollment was significantly less likely among Black (odds ratio, 0.55; 95% confidence interval, 0.5-0.7, P < .001) and Hispanic (0.66; 95% confidence interval, 0.5-0.9, P = .01) patients. Patients with Medicaid or uninsured, in the lowest socioeconomic status group, and those treated at community-based cancer programs were the least likely to enroll. CONCLUSIONS: Enrollment in lung cancer trials disproportionally excludes minority patients, those in the lowest socioeconomic status, community cancer programs, and the underinsured. These disparities in demographic and access for trial participation show a need for improved enrollment strategies.

Underrepresentation of racial and ethnic minority groups in gynecologic oncology: An analysis of over 250 trials.

OBJECTIVE: To describe the participation of racial and ethnic minority groups (REMGs) in gynecologic oncology trials. METHODS: Gynecologic oncology studies registered on ClinicalTrials.gov between 2007 and 2020 were identified. Trials with published results were analyzed based on reporting of race/ethnicity in relation to disease site and trial characteristics. Expected enrollment by race/ethnicity was calculated and compared to actual enrollment, adjusted for 2010 US Census population data. RESULTS: 2146 gynecologic oncology trials were identified. Of published trials (n = 252), 99 (39.3%) reported race/ethnicity data. Recent trials were more likely to report these data (36% from 2007 to 2009; 51% 2013-2015; and 53% from 2016 to 2018, p = 0.01). Of all trials, ovarian cancer trials were least likely to report race/ethnicity data (32.1% vs 39.3%, p = 0.011). Population-adjusted under-enrollment for Blacks was 7-fold in ovarian cancer, Latinx 10-fold for ovarian and 6-fold in uterine cancer trials, Asians 2.5-fold in uterine cancer trials, and American Indian and Alaska Native individuals 6-fold in ovarian trials. Trials for most disease sites have enrolled more REMGs in recent years - REMGs made up 19.6% of trial participants in 2007-2009 compared to 38.1% in 2016-2018 (p < 0.0001). CONCLUSION: Less than half of trials that published results reported race/ethnicity data. Available data reveals that enrollment of REMGs is significantly below expected rates based on national census data. These disparities persisted even after additionally adjusting for population size. Despite improvement in recent years, additional recruitment of REMGs is needed to achieve more representative and equitable participation in gynecologic cancer clinical trials.

Outcomes of Patients with Newly Diagnosed Transplant-Ineligible Multiple Myeloma According to Clinical Trials Enrollment: Experience of a Single Institution.

The proportion of non-transplant-eligible (NTE) newly diagnosed multiple myeloma (NDMM) patients excluded from clinical trials (CTs) and their prognosis is unknown. CT results may not be generalizable to real-world practice due to strict recruitment criteria. We analyzed causes of NTE-NDMM patient exclusion form CTs and their outcomes. A total of 211 NTE-NDMM patients were included. They were divided into three periods: 2003-2007, 2008-2012, and 2013-2017. Overall, 50% received non-trial treatment (NCT), while 50% participated in a CT (20% control group (CG) and 30% experimental group (EG)). Main causes for exclusion from CTs were comorbidities, ECOG > 2, and renal insufficiency. In the first two periods, the CR rate was similar regardless of treatment type, but in the last period, the EG group showed improved CR. Median PFS was similar in the first two periods, with a benefit seen only in the EG in the last period. The median OS was significantly longer in CT-included patients compared to NCT group in the last two periods. Conclusions: The presence of comorbidities and worsened ECOG were the main reasons for CT exclusion. Patients included in CTs had a longer OS than NCT. This OS benefit may be influenced by a selection bias, making it challenging to generalize CT results to real clinical practice.

Evaluation of Informed Consent with Teach-Back and Audio Assistance to Improve Willingness to Participate in a Clinical Trial Among Underrepresented Minorities: A Randomized Pilot Trial.

The informed consent form (ICF) is intended to assure that subject participation in research studies is informed and voluntary. Yet, there is ample evidence that many subjects do not adequately understand the concepts and language in a clinical trial ICF, which may undermine their willingness to participate in a clinical trial. In a randomized setting, we compared a standard read-only ICF to an audio-assisted ICF with or without teach-back. We found that audio-assisted ICFs significantly improved willingness to participate in a mock clinical trial among our sample of primarily African-American participants.

Disparities in US Lung Cancer Clinical Trial Enrollment.

BACKGROUND: Disparities within clinical trial enrollment are well-documented, reducing the generalizability of results. Although nearly 30 years have passed since Congress passed the NIH Revitalization Act to encourage the participation of minoritized populations in clinical trials, these patients continue to be underrepresented. This study aimed to investigate lung cancer clinical trial enrollment disparities for race/ethnicity, sex, and age. METHODS: We queried the National Institutes of Health: US National Library of Medicine database of clinical trials for all US-based lung cancer clinical trials completed between 2004 and 2021 and collected data on race and ethnicity, gender, and age breakdown. This data was compared to Surveillance, Epidemiology, and End Results (SEER) database data. Independent sample t-tests and Kruskal-Wallis's approach were used to analyze the data. RESULTS: Of 311 eligible trials with exclusive US enrollment, 136 (44%) reported race and ethnicity breakdown for the patient cohort representing 9869 patients. Hispanic, Non-Hispanic American Indian/Alaska Native, Non-Hispanic Black, and Non-Hispanic Unreported participants were underrepresented (p = 0.001, p = 0.005, p = 0.014, p = 0.002, respectively). Non-Hispanic White participants were overrepresented (p = 0.018). Disparities worsened from 2017 to 2021 for Hispanic patients (p = 0.03). No significant differences were found for sex or age. CONCLUSIONS: Disparities for clinical lung cancer trial enrollment have not shown statistically significant improvement since 2004, and representation remains unequal, especially for racial and ethnic minorities.

Racial disparity in the genomics of precision oncology of prostate cancer.

BACKGROUND: Significant racial disparities in prostate cancer incidence and mortality have been reported between African American Men (AAM), who are at increased risk for prostate cancer, and European American Men (EAM). In most of the studies carried out on prostate cancer, this population is underrepresented. With the advancement of genome-wide association studies, several genetic predictor models of prostate cancer risk have been elaborated, as well as numerous studies that identify both germline and somatic mutations with clinical utility. RECENT FINDINGS: Despite significant advances, the AAM population continues to be underrepresented in genomic studies, which can limit generalizability and potentially widen disparities. Here we outline racial disparities in currently available genomic applications that are used to estimate the risk of individuals developing prostate cancer and to identify personalized oncology treatment strategies. While the incidence and mortality of prostate cancer are different between AAM and EAM, samples from AAM remain to be unrepresented in different studies. CONCLUSION: This disparity impacts the available genomic data on prostate cancer. As a result, the disparity can limit the predictive utility of the genomic applications and may lead to the widening of the existing disparities. More studies with substantially higher recruitment and engagement of African American patients are necessary to overcome this disparity.

Clinically stable covid-19 patients presenting to acute unscheduled episodic care venues have increased risk of hospitalization: secondary analysis of a randomized control trial.

BACKGROUND: Assessment for risks associated with acute stable COVID-19 is important to optimize clinical trial enrollment and target patients for scarce therapeutics. To assess whether healthcare system engagement location is an independent predictor of outcomes we performed a secondary analysis of the ACTIV-4B Outpatient Thrombosis Prevention trial. METHODS: A secondary analysis of the ACTIV-4B trial that was conducted at 52 US sites between September 2020 and August 2021. Participants were enrolled through acute unscheduled episodic care (AUEC) enrollment location (emergency department, or urgent care clinic visit) compared to minimal contact (MC) enrollment (electronic contact from test center lists of positive patients).We report the primary composite outcome of cardiopulmonary hospitalizations, symptomatic venous thromboembolism, myocardial infarction, stroke, transient ischemic attack, systemic arterial thromboembolism, or death among stable outpatients stratified by enrollment setting, AUEC versus MC. A propensity score for AUEC enrollment was created, and Cox proportional hazards regression with inverse probability weighting (IPW) was used to compare the primary outcome by enrollment location. RESULTS: Among the 657 ACTIV-4B patients randomized, 533 (81.1%) with known enrollment setting data were included in this analysis, 227 from AUEC settings and 306 from MC settings. In a multivariate logistic regression model, time from COVID test, age, Black race, Hispanic ethnicity, and body mass index were associated with AUEC enrollment. Irrespective of trial treatment allocation, patients enrolled at an AUEC setting were 10-times more likely to suffer from the adjudicated primary outcome, 7.9% vs. 0.7%; p < 0.001, compared with patients enrolled at a MC setting. Upon Cox regression analysis adjustment patients enrolled at an AUEC setting remained at significant risk of the primary composite outcome, HR 3.40 (95% CI 1.46, 7.94). CONCLUSIONS: Patients with clinically stable COVID-19 presenting to an AUEC enrollment setting represent a population at increased risk of arterial and venous thrombosis complications, hospitalization for cardiopulmonary events, or death, when adjusted for other risk factors, compared with patients enrolled at a MC setting. Future outpatient therapeutic trials and clinical therapeutic delivery programs of clinically stable COVID-19 patients may focus on inclusion of higher-risk patient populations from AUEC engagement locations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04498273.

Access Denied: Disparities in Thyroid Cancer Clinical Trials.

For thyroid cancer clinical trials, the inclusion of participants from diverse patient populations is uniquely important given existing racial/ethnic disparities in thyroid cancer care. Since 2011, a paradigm shift has occurred in the treatment of advanced thyroid cancer with the approval of multiple systemic therapies by the US Food and Drug Administration based on their use in the clinical trials setting. Although these clinical trials recruited patients from up to 164 sites in 25 countries, the inclusion of racial/ethnic minority patients remained low. In this mini-review, we provide an overview of barriers to accessing cancer clinical trials, framed in the context of why patients with thyroid cancer may be uniquely vulnerable. Multilevel interventions and increased funding for thyroid cancer research are necessary to increase access to and recruitment of under-represented patient populations into thyroid cancer clinical trials.