Cancer clinical trial accessibility in the United States: An analysis of travel distance.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6540-6540
Author(s):  
Asma Latif ◽  
Kristian D Stensland ◽  
Ryan Hendricks ◽  
Erin L. Moshier ◽  
James H. Godbold ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trial ◽  
The United States ◽  
Travel Distance ◽  
Cancer Clinical Trial ◽  
Phase Iii ◽  
Tumor Type ◽  
Trial Site ◽  
Cancer Trials ◽  
Zip Code

6540 Background: Accessibility of cancer clinical trials has been cited as a barrier to participation. While there are several dimensions to accessibility, travel distance may represent an important measure with potential socio-demographic implications. We sought to identify the driving distance from each ZIP-code in the United States to the nearest clinical trial site for four common solid tumors, and correlate ZIP-code level demographics with travel distance. Methods: The ClinicalTrials.gov database was queried on September 12, 2012 to identify all open, actively recruiting phase II and phase III therapeutic interventional trials in first-line metastatic disease for the four most common solid tumor types in the United States (prostate, breast, lung, and colorectal). Driving distance from each ZIP-code in the continental United States to the nearest trial site for each tumor type was calculated. Trial sites located within the ZIP-code were set at a travel distance of 0 miles. ZIP-code level demographics, derived from the 2010 Census, were correlated with driving distance. Results: We identified 42 prostate cancer trials with 958 sites, 81 breast cancer trials with 1,345 sites, 83 lung cancer trials with 2,249 sites, and 32 colorectal cancer trials with 566 sites which met inclusion criteria. The travel distances for each tumor type are shown in the Table. Analyses correlating driving distance with ZIP-code level demographics are ongoing. Conclusions: Substantial heterogeneity exists regarding accessibility of cancer trials in the United States as measured by driving distance. The optimal geographic distribution of trials, the burden imposed by travel, and the degree to which travel distance contributes to poor cancer clinical trial enrollment all warrant further investigation. [Table: see text]

Distribution and geographic accessibility of prostate cancer clinical trials in the United States.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 59-59 ◽  
Author(s):  
Matt D. Galsky ◽  
Asma Latif ◽  
Kristian D. Stensland ◽  
Erin L. Moshier ◽  
Russell McBride ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Geographic Distribution ◽  
The United States ◽  
First Line ◽  
Trial Site ◽  
Lorenz Curves ◽  
Number Of Patients

59 Background: An extremely small proportion of patients with cancer in the United States (US) enroll in clinical trials. While several barriers to trial accrual have been described, the geographic distribution and accessibility of clinical trial sites has not been comprehensively explored. Methods: ClinicalTrials.gov was queried to identify all active US clinical trials exploring first-line therapies for metastatic prostate cancer (PCa) on 9/16/2012. We evaluated the geographic distribution of trial sites and determined the relationship between the number of sites and the number of patients with advanced PCa per county and evaluated heterogeneity using Lorenz curves. We also estimated the minimum driving distance required to access a clinical trial site from each ZIP code in the continguous US; a distance >30 miles was defined as high travel burden consistent with prior studies. Results: We identified 958 sites associated with 42 PCa clinical trials (Table). The geographic distribution of clinical trial sites was very inhomogeneous with several states having only 1-2 trial sites. Among 3185 US counties, 2,669 (83.8%) had no clinical trials available for first-line treatment of metastatic PCa. Counties with larger populations of patients with advanced PCa had significantly higher numbers of clinical trial sites. For every 100 additional patients with advanced PCa per county, the number of available trial sites increased by 21.0% (95% CI: 16.5-25.7%). However, Lorenz curves indicated a high degree of inequality in trial accessibility (Gini index 0.71). Approximately 31% of the US population resided >30 miles from a PCa trial site. Conclusions: Clinical trials sites are poorly accessible, geographically, to a large subset of US PCa patients, a finding that likely contributes to dismal accrual. Innovative solutions are required to address geographic barriers to access. [Table: see text]

Accrual of older adults to Canadian Cancer Trials Group (CCTG) led trials: A retrospective analysis from 1990 to 2015.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 10031-10031
Author(s):  
Catalina Hernandez Torres ◽  
Winson Y. Cheung ◽  
Christopher J. O'Callaghan ◽  
Tina Hsu
Keyword(s):  
Older Adults ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Phase Iii ◽  
Tumor Type ◽  
Tumour Site ◽  
Exclusion Criteria ◽  
Early Stage Disease ◽  
Major Barrier ◽  
Cancer Trials

10031 Background: Older adults (OA) age 65+ make up to 60% of all newly diagnosed cancers. However, only 22-32% of patients accrued in cooperative group studies in the 1990s were age 65+. In 2003, several studies suggested that clinical trial design, in particular the presence of strict exclusion criteria, was a major barrier to accrual of OA. The objective of this study was to determine: 1) whether there has been an improvement in accrual of OA to clinical trials led by the Canadian Cancer Trials Group (CCTG) over time; 2) clinical trial features associated with accrual of OA to clinical trials 3) whether exclusion criteria in trials initiated 2003 or after have been relaxed. Methods: All completed randomized Phase II and III CCTG-led clinical trials initiated between 1990 or later were included. Trial characteristics including tumor type, stage, treatment type, and exclusion/inclusion criteria, as well as percentage of OA age 65+ accrued were recorded. Association between percentage of OA accrued and trial characteristics were compared using the Wilcoxin rank sum test. Assessment of exclusion criteria before and after 2003 was compared using the Chi Square test or Fisher exact test. Results: A total of 68 trials were included. Most trials were phase III (73%), chemotherapy trials (48%), opened before 2003 (70.6%), advanced disease (73%) and lung cancer was the most common tumour site (17.6%). OA accrual remains low compared to OA diagnosed with cancer in Canada (41% vs. 56%, p < 0.001). There was an improvement in accrual of OA after 2003 (47.1% vs. 34.9%, p = 0.02). Tumour site, early stage disease, more restrictive performance status, requiring a new biopsy, and having a longer consent form, were associated with lower accrual of OA (p < 0.05). There was no significant loosening of exclusion with time though patients with pulmonary comorbidities were more likely to be excluded in studies initiated in 2003 or later (p = 0.006). Conclusions: OA remain under-represented in clinical trials. There has been no relaxing of exclusion criteria; however, exclusion based on comorbidities was not significantly associated with under accrual of OA in our study.

The case for proactive, collaborative data-updating in a statewide cancer clinical trial matching service

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6570-6570
Author(s):  
K. Moffitt ◽  
R. D. Marsh ◽  
C. Hudson
Keyword(s):  
Clinical Trial ◽  
The United States ◽  
Cancer Clinical Trial ◽  
Trial Participation ◽  
Web Based ◽  
Trial Site ◽  
Monthly Data ◽  
Data Verification ◽  
Grass Roots ◽  
Data Updating

6570 Background Florida has the second highest cancer incidence of any state in the United States. To address Florida's growing cancer burden and the need for increased clinical trial participation, Florida Cancer Trials (FCT) launched a web-based and phone-based Clinical Trial Matching Service for the State of Florida on November 1, 2004 (operated by EmergingMed). After 2 years of monthly outreach to 96 trial sites, the FCT wanted to assess the outcome and ongoing need for intensive, grass-roots data verification activities in light of other publicly available cancer clinical trial databases. Methods On 10/23/06, FCT staff extracted all trials containing at least one Florida trial site from the PDQ and ClinicalTrials.gov (CT.gov) database. The same extraction was produced from the TrialCheck database on 11/10/06. Each database was compared to the list of active cancer clinical trials in the FCT/EmergingMed database on the same day. Every trial-site listed in the PDQ/CT.gov database, but missing from the FCT/EmergingMed database, was contacted by FCT staff to confirm the accuracy of each trial/site combination. Results PDQ/CT.gov contained 547 trials listed with Florida trial sites on 10/23/06 (the FCT/EmergingMed database contained 526 trials on the same day). On 11/10/06, the TrialCheck database listed 528 trials with Florida trial sites (the FCT/EmergingMed database contained 513 verified trials on the same day). The PDQ/CT.gov database was missing 25% of Florida's open trials, while the TrialCheck database was missing 36% of Florida's open trials. Moreover, 19% of PDQ/CT.gov's trial listings and 25% of TrialCheck's listings for Florida were erroneous. Conclusions With 25%–36% of Florida's trials missing from public databases, and 19%–25% of their current listings being false listings for Florida, the FCT continues to conclude that a grass-roots, monthly data verification schedule is necessary to maintain a cancer clinical trial database that is suitable for use in referring patients and physicians to Florida's cancer clinical trial sites. No significant financial relationships to disclose.

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 ◽  
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.

Phase III Trials in Pancreatic Cancer in the United States

2010 ◽  
Vol 9 (1) ◽  
pp. 59-60
Author(s):  
Edward Chu ◽  
David Cunningham ◽  
David Watkins
Keyword(s):  
United States ◽  
Pancreatic Cancer ◽  
The United States ◽  
Phase Iii ◽  
Phase Iii Trials

A randomized phase III, two-arm trial of paclitaxel, carboplatin, and maintenance letrozole versus letrozole monotherapy in patients with stage II-IV, primary low-grade serous carcinoma of the ovary or peritoneum.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS5601-TPS5601
Author(s):  
Amanda Nickles Fader ◽  
Lilian Tran Gien ◽  
Austin Miller ◽  
Al Covens ◽  
David Marc Gershenson
Keyword(s):  
Clinical Trial ◽  
Maintenance Therapy ◽  
Aromatase Inhibitor ◽  
The United States ◽  
Stage Ii ◽  
Phase Iii ◽  
Serous Carcinoma ◽  
Low Grade ◽  
Information Time ◽  
Carcinoma Of The Ovary

TPS5601 Background: Low-grade serous carcinoma of the ovary or peritoneum (LGSOC) is a rare subtype of epithelial carcinoma. Differences in epidemiology, pathogenesis, disease presentation, and clinical outcomes have been characterized between women diagnosed with LGSOC and those with the p53-driven high-grade serous carcinoma (HGSOC). Ultimately, patients with LGSOC should be treated differently than those with HGSOC. Several studies suggest that LGSOC is relatively chemoresistant and that most tumors robustly express estrogen and progesterone receptors. Recently, retrospective reports suggest that utilization of the aromatase inhibitor, letrozole, as monotherapy or in addition to platinum/taxane-based chemotherapy in those with primary advanced-stage LGSOC results in preliminarily promising survival outcomes. Methods: This study is a two-arm, randomized, open-label, Phase III clinical trial. The primary objective is to assess whether letrozole monotherapy (2.5 mg po daily) is non-inferior to carboplatin (AUC 5-6) and paclitaxel (175 mg/m2) followed by letrozole maintenance therapy with respect to progression free survival in women with primary, Stage II-IV LGSOC who have undergone an attempt at maximal surgical cytoreduction. Secondary endpoints include incidence of adverse events, objective response rate in those with measurable disease after surgery, response duration, overall survival, and adherence to letrozole maintenance therapy. Study subjects must have undergone a bilateral salpingo-oophorectomy, and p53 IHC testing of tumors is required to rule out those with aberrant p53 expression commonly observed in HGSOC tumors. Study strata include residual disease status and country of enrollment. Four hundred and fifty patients will be enrolled in the United States, Canada and South Korea through the NRG Oncology trials network. Correlative aims include analyzing the association of ER/PR tumoral expression with aromatase inhibitor therapy response and determining ESR1 mutational status in those who develop letrozole resistance. The study includes two interim analyses; at 20% information time, a futility analysis will be conducted, and at 40% information time, both efficacy and futility will be assessed. This is one of the first randomized trials performed in women with primary, advanced LGSOC, and the study is open with 71 patients enrolled at the time of abstract submission. Clinical trial information: NCT04095364.

Quality of Life and the Carbon Footprint: A Zip-Code Level Study Across the United States

2021 ◽  
Vol 30 (4) ◽  
pp. 323-343
Author(s):  
Matthew Thomas Clement ◽  
Chad L. Smith ◽  
Tyler Leverenz
Keyword(s):  
Quality Of Life ◽  
United States ◽  
Carbon Footprint ◽  
Ecological Impact ◽  
Well Being ◽  
The United States ◽  
Alternative Measure ◽  
Level Data ◽  
Zip Code

Much sustainability scholarship has examined the environmental dimensions of subjective and objective well-being. As an alternative measure of human well-being, we consider the notion of quality of life and draw on a framework from the sustainability literature to study its association with ecological impact, specifically the carbon footprint. We conduct a quantitative analysis, combining zip-code level data on quality of life and the carbon footprint per household for the year 2012 across the continental United States ( n=29,953). Findings consistently show a significant, negative association between quality of life and the carbon footprint. Our findings point to the potential advantages of utilizing robust objective measures of quality of life that extends beyond economic well-being and life expectancy alone. Furthermore, our findings question the conventional wisdom that sustainability requires sacrifices, while suggesting opportunities for how increased levels of sustainability may be achieved while retaining high levels of quality of life.

scholarly journals Examining dispatching practices for Interagency Hotshot Crews to reduce seasonal travel distance and manage fatigue

2018 ◽  
Vol 27 (9) ◽  
pp. 569 ◽  
Author(s):  
Erin J. Belval ◽  
David E. Calkin ◽  
Yu Wei ◽  
Crystal S. Stonesifer ◽  
Matthew P. Thompson ◽  
...  
Keyword(s):  
United States ◽  
The United States ◽  
Travel Distance ◽  
Simulation Process ◽  
Fatigue Management ◽  
Potential Benefits ◽  
Management Policies ◽  
Optimisation Model ◽  
Fatigue Mitigation ◽  
Travel Distances

Interagency Hotshot Crews (IHCs) are a crucial firefighting suppression resource in the United States. These crews travel substantial distances each year and work long and arduous assignments that can cause accumulated fatigue. Current dispatching practices for these crews are supposed to send the closest resource while adhering to existing fatigue-management policies. In this research, we designed a simulation process that repeatedly implements an optimisation model to assign crews to suppression requests. This study examines the potential effects of using an optimisation approach to shorten seasonal crew travel distances and mitigate fatigue. We also examine the potential benefits of coordinating crew-dispatch decisions to meet multiple requests. Results indicate there is substantial room for improvement in reducing travel distances while still balancing crew fatigue; coordinating crew dispatching for multiple requests can increase the assignment efficiency, particularly when both fatigue mitigation and travel distances are jointly optimised. This research indicates implementing an optimisation model for dispatching IHCs is promising.

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