EPID-07. ACCESS TO GLIOBLASTOMA CLINICAL TRIALS FOR RURAL PATIENTS IN THE UNITED STATES FROM 2010–2020

Abstract BACKGROUND Patients in rural communities have less access to optimal cancer care and clinical trials. For GBM, access to experimental therapies, and consideration of a clinical trial is embedded in national guidelines. Still, the availability of clinical trials to rural communities, representing 20% of the US population, has not been described. METHODS We queried ClinicalTrials.gov for glioblastoma interventional treatment trials opened between 1/2010 and 1/2020 in the United States. We created a Structured Query Language database and leveraged Google application programming interfaces (API) Places to find name and street addresses for the sites, and Google’s Geocode API to determine the county location. Counties were classified by US Department of Agriculture Rural-Urban Continuum Codes (RUCC 1–3 = urban and RUCC 4–9 = rural). We used z-ratios for rural-urban statistical comparisons. RESULTS We identified 406 interventional treatment trials for GBM at 1491 unique sites. 8.7% of unique sites were in rural settings. Rural sites opened an average of 1.7 trials/site and urban sites 2.8 trials/site from 1/2010–1/2020. Rural sites offered more phase II trials (63% vs 57%, p= 0.03) and fewer phase I trials (22% vs 28%, p= 0.01) than urban sites. Rural locations were more likely to offer federally-sponsored trials (p< 0.002). There were no investigator-initiated or single-institution trials offered at rural locations, and only 1% of industry trials were offered rurally. DISCUSSION Clinical trials for GBM were rarely open in rural areas, and were more dependent on federal funding. Clinical trials are likely difficult to access for rural patients, and this has important implications for the generalizability of research as well as how we engage the field of neuro-oncology and patient advocacy groups in improving patient access to trials. Increasing the number of clinical trials in rural locations may enable more rural patients to access and enroll in GBM studies.

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How Sociodemographics, Presence of Oncology Specialists, and Hospital Cancer Programs Affect Accrual to Cancer Treatment Trials

Journal of Clinical Oncology ◽

10.1200/jco.2002.08.056 ◽

2002 ◽

Vol 20 (8) ◽

pp. 2109-2117 ◽

Cited By ~ 331

Author(s):

Warren B. Sateren ◽

Edward L. Trimble ◽

Jeffrey Abrams ◽

Otis Brawley ◽

Nancy Breen ◽

...

Keyword(s):

United States ◽

Clinical Trials ◽

Health Insurance ◽

Cancer Treatment ◽

Cancer Patients ◽

Asian American ◽

The United States ◽

Health Maintenance ◽

Treatment Trials ◽

The Impact

PURPOSE: We chose to examine the impact of socioeconomic factors on accrual to National Cancer Institute (NCI)–sponsored cancer treatment trials. PATIENTS AND METHODS: We estimated the geographic and demographic cancer burden in the United States and then identified 24,332 patients accrued to NCI-sponsored cancer treatment trials during a 12-month period. Next, we examined accrual by age, sex, geographic residence, health insurance status, health maintenance organization market penetration, several proxy measures of socioeconomic status, the availability of an oncologist, and the presence of a hospital with an approved multidisciplinary cancer program. RESULTS: Pediatric patients were accrued to clinical trials at high levels, whereas after adolescence, only a small percentage of cancer patients were enrolled onto clinical trials. There were few differences by sex. Black males as well as Asian-American and Hispanic adults were accrued to clinical trials at lower rates than white cancer patients of the same age. Overall, the highest observed accrual was in suburban counties. Compared with the United States population, patients enrolled onto clinical trials were significantly less likely to be uninsured and more like to have Medicare health insurance. Geographic areas with higher socioeconomic levels had higher levels of clinical trial accruals. The number of oncologists and the presence of approved cancer programs both were significantly associated with increased accrual to clinical trials. CONCLUSION: We must work to increase the number of adults who enroll onto trials, especially among the elderly. Ongoing partnership with professional societies may be an effective approach to strengthen accrual to clinical trials.

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Developing a Clinical Trials Infrastructure in the United States

NAM Perspectives ◽

10.31478/201205g ◽

2012 ◽

Vol 2 (5) ◽

Author(s):

Paul Eisenberg ◽

◽

Petra Kaufmann ◽

Ellen Sigal ◽

Janet Woodcock ◽

...

Keyword(s):

United States ◽

Clinical Trials ◽

The United States

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690 Are participants in obstetrical randomized clinical trials representative of the United States pregnant population?

American Journal of Obstetrics and Gynecology ◽

10.1016/j.ajog.2020.12.714 ◽

2021 ◽

Vol 224 (2) ◽

pp. S433

Author(s):

Cynthia Coots ◽

Stephen Wagner ◽

Matthew J. Bicocca ◽

Megha Gupta ◽

Hector Mendez Figueroa ◽

...

Keyword(s):

United States ◽

Clinical Trials ◽

Randomized Clinical Trials ◽

The United States

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Identification of Potential Freight Parking Locations in Urban Areas

Transportation Research Record Journal of the Transportation Research Board ◽

10.1177/03611981211013027 ◽

2021 ◽

pp. 036119812110130

Author(s):

Glenn Vorhes ◽

Ernest Perry ◽

Soyoung Ahn

Keyword(s):

United States ◽

Information System ◽

Satellite Imagery ◽

Urban Areas ◽

The United States ◽

Truck Drivers ◽

Short List ◽

Automated Processes ◽

Parking Facilities ◽

Urban Sites

Truck parking is a crucial element of the United States’ transportation system as it provides truckers with safe places to rest and stage for deliveries. Demand for truck parking spaces exceeds supply and shortages are especially common in and around urban areas. Freight operations are negatively affected as truck drivers are unable to park in logistically ideal locations. Drivers may resort to unsafe practices such as parking on ramps or in abandoned lots. This report seeks to examine the potential parking availability of vacant urban parcels by establishing a methodology to identify parcels and examining whether the identified parcels are suitable for truck parking. Previous research has demonstrated that affordable, accessible parcels are available to accommodate truck parking. When used in conjunction with other policies, adaptation of urban sites could help reduce the severity of truck parking shortages. Geographic information system parcel and roadway data were obtained for one urban area in each of the 10 Mid America Association of Transportation Officials region states. Area and proximity filters were applied followed by spectral analysis of satellite imagery to identify candidate parcels for truck parking facilities within urban areas. The automated processes created a ranked short list of potential parcels from which those best suited for truck parking could be efficiently identified for inspection by satellite imagery. This process resulted in a manageable number of parcels to be evaluated further by local knowledge metrics such as availability and cost, existing infrastructure and municipal connections, and safety.

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The United States’ Regulatory Environment Is Evolving to Accommodate a Coming Boom in Gene Therapy Research

Applied Biosafety ◽

10.1177/1535676019854866 ◽

2019 ◽

Vol 24 (3) ◽

pp. 147-152 ◽

Cited By ~ 2

Author(s):

Daniel Eisenman

Keyword(s):

United States ◽

Gene Therapy ◽

Clinical Trials ◽

The United States ◽

Regulatory Environment ◽

Evidence Based ◽

Regulatory Structure ◽

Regulatory Changes ◽

Current State ◽

Therapy Field

Introduction: A dramatic increase in the number of clinical trials involving gene-modified cell therapy and gene therapy is taking place. The field is on the verge of a boom, and the regulatory environment is evolving to accommodate the growth. Discussion: This commentary summarizes the current state of the field, including an overview of the growth. The United States (US) regulatory structure for gene therapy will be summarized, and the evolution of the oversight structure will be explained. Conclusion: The gene therapy field has recently produced its first FDA-approved therapeutics and has a pipeline of other investigational products in the final stages of clinical trials before they can be evaluated by the FDA as safe and effective therapeutics. As research continues to evolve, so must the oversight structure. Biosafety professionals and IBCs have always played key roles in contributing to the safe, evidence-based advancement of gene therapy research. With the recent regulatory changes and current surge in gene therapy research, the importance of those roles has increased dramatically.

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Considerations for Tissue-Engineered and Regenerative Medicine Product Development Prior to Clinical Trials in the United States

Tissue Engineering Part B Reviews ◽

10.1089/ten.teb.2009.0449 ◽

2010 ◽

Vol 16 (1) ◽

pp. 41-54 ◽

Cited By ~ 91

Author(s):

Mark H. Lee ◽

Judith A. Arcidiacono ◽

Anastacia M. Bilek ◽

Jeremiah J. Wille ◽

Caitilin A. Hamill ◽

...

Keyword(s):

United States ◽

Clinical Trials ◽

Regenerative Medicine ◽

Product Development ◽

The United States ◽

Medicine Product

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Impact of the Year 2000 Medicare Policy Change on Older Patient Enrollment to Cancer Clinical Trials

Journal of Clinical Oncology ◽

10.1200/jco.2005.02.8928 ◽

2006 ◽

Vol 24 (1) ◽

pp. 141-144 ◽

Cited By ~ 81

Author(s):

Joseph M. Unger ◽

Charles A. Coltman ◽

John J. Crowley ◽

Laura F. Hutchins ◽

Silvana Martino ◽

...

Keyword(s):

Clinical Trials ◽

Policy Change ◽

Positive Impact ◽

The United States ◽

Older Patient ◽

Treatment Trials ◽

Race Ethnicity ◽

Method Of Payment ◽

Medicare Policy ◽

Year 2000

Purpose A prior analysis by the Southwest Oncology Group (SWOG) showed that women and African American patients were adequately represented on cancer clinical treatment trials but that older patients were substantially underrepresented. Twenty-five percent of patients ≥ 65 years old were enrolled onto SWOG trials from 1993 to 1996, whereas 63% of all patients with cancer were ≥ 65 years old. Recognition of this under-representation led to a change in Medicare policy in 2000 to include coverage of routine patient care costs of clinical trials. We conducted an updated analysis of accrual trends. Methods The proportions of enrollment onto SWOG treatment trials by sex, race/ethnicity, and age (≥ 65 years) were computed for the years 1997 to 2000; corresponding rates in the United States were derived from US Census and National Cancer Institute Surveillance, Epidemiology, and End Results data. Additionally, method of payment data were analyzed over time (1993 to 2003) to assess whether patterns in method of payment changed with the new Year 2000 Medicare policy on clinical trials coverage. Results The results showed continued adequate representation by sex and race/ethnicity. Older patient accrual on SWOG trials increased significantly since 2000, with 31% of patients ≥ 65 years old enrolled from 1997 to 2000 and 38% enrolled from 2001 to 2003 (v 25% from 1993 to 1996). The percentage of patients using Medicare plus supplemental insurance also increased beginning in 2000, whereas the percentage of patients using Medicare alone remained the same. Conclusion Method of payment analyses provided evidence that the Year 2000 Medicare policy change had a positive impact, but only for those patients with supplemental private coverage of coinsurance costs. Improvements in the Medicare payment structure could further increase older patient participation in clinical trials.

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

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e18501 ◽

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.

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