Pancreatic Cancer Clinical Trials and Accrual in the United States

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.

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

10.31219/osf.io/rx95f ◽

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.

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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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Optimizing Cancer Clinical Trials Research Investment Decisions In The United States: A Proof Of Concept Portfolio Management Evaluation

Value in Health ◽

10.1016/j.jval.2015.03.055 ◽

2015 ◽

Vol 18 (3) ◽

pp. A8

Author(s):

C.S. Bennette ◽

J.A. Roth ◽

A. Basu ◽

J.J. Carlson ◽

S. Ramsey ◽

...

Keyword(s):

United States ◽

Clinical Trials ◽

Portfolio Management ◽

Investment Decisions ◽

The United States ◽

Cancer Clinical Trials ◽

Proof Of Concept ◽

Management Evaluation ◽

Research Investment

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The Present Status of Immuno-Oncolytic Viruses in the Treatment of Pancreatic Cancer

Viruses ◽

10.3390/v12111318 ◽

2020 ◽

Vol 12 (11) ◽

pp. 1318

Author(s):

Scott D. Haller ◽

Michael L. Monaco ◽

Karim Essani

Keyword(s):

United States ◽

Pancreatic Cancer ◽

Surgical Resection ◽

Clinical Investigation ◽

Treatment Options ◽

Late Phase ◽

The United States ◽

Oncolytic Viruses ◽

Ductal Adenocarcinoma ◽

Treatment Regimens

Pancreatic ductal adenocarcinoma (PDAC) is the fifth leading cause of cancer-related death in Western countries. The incidence of PDAC has increased over the last 40 years and is projected to be the second leading cause of cancer death by 2030. Despite aggressive treatment regimens, prognosis for patients diagnosed with PDAC is very poor; PDAC has the lowest 5-year survival rate for any form of cancer in the United States (US). PDAC is very rarely detected in early stages when surgical resection can be performed. Only 20% of cases are suitable for surgical resection; this remains the only curative treatment when combined with adjuvant chemotherapy. Treatment regimens excluding surgical intervention such as chemotherapeutic treatments are associated with adverse effects and genetherapy strategies also struggle with lack of specificity and/or efficacy. The lack of effective treatments for this disease highlights the necessity for innovation in treatment options for patients diagnosed with early- to late-phase PDAC and immuno-oncolytic viruses (OVs) have been of particular interest since 2006 when the first oncolytic virus was approved as a therapy for nasopharyngeal cancers in China. Interest resurged in 2015 when T-Vec, an oncolytic herpes simplex virus, was approved in the United States for treatment of advanced melanoma. While many vectors have been explored, few show promise as treatment for pancreatic cancer, and fewer still have progressed to clinical trial evaluation. This review outlines recent strategies in the development of OVs targeting treatment of PDAC, current state of preclinical and clinical investigation and application.

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

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.6540 ◽

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]

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

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.4_suppl.59 ◽

2014 ◽

Vol 32 (4_suppl) ◽

pp. 59-59 ◽

Cited By ~ 2

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]

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An Investigation into the Therapeutic Action of Hydroxyzine (Atarax) in the Treatment of Nervous Disorders and the Control of the Tobacco-Habit

Journal of Mental Science ◽

10.1192/bjp.104.436.826 ◽

1958 ◽

Vol 104 (436) ◽

pp. 826-833 ◽

Cited By ~ 7

Author(s):

G. C. Turle

Keyword(s):

United States ◽

Clinical Trial ◽

Clinical Trials ◽

Side Effects ◽

Young Children ◽

Mental Hospital ◽

The United States ◽

Child Guidance Clinic ◽

Therapeutic Action ◽

Child Guidance

Hydroxyzine hydrochloride (Atarax, UCB 4492) is a tranquillizer which has attracted much interest in the United States, where it has undergone a series of clinical trials with encouraging results. In order to test the claims of American investigators a trial of hydroxyzine was made on a group of psychotic and psychoneurotic patients in a large mental hospital. The effectiveness of hydroxyzine in controlling the tobacco habit was also tested by using volunteer nurses at the hospital. Their observations provided useful information on the subjective action and side effects of the drug. A small number of young children attending a local child guidance clinic were also included in the clinical trial.

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Disparity in Clinical Trial Opportunities for Patients with B-Cell Malignancies in the United States

Blood ◽

10.1182/blood-2018-99-117155 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 4861-4861

Author(s):

Sikander Ailawadhi ◽

Sri Lekha Bodepudi ◽

Zan Tahir Shareef ◽

Fabiola Coromoto Cardozo ◽

Salman Ahmed ◽

...

Keyword(s):

United States ◽

Clinical Trial ◽

Clinical Trials ◽

Geographical Distribution ◽

Research Funding ◽

Phase 1 ◽

The United States ◽

Phase 2 ◽

B Cell Malignancies ◽

The Us

Abstract Background: Clinical trials are fundamental to advance therapeutics systematically and improve patient outcomes. Despite this, enrollment on clinical trials remains dismal in the United States (US) and is a constant focus of healthcare policy. We studied distribution of clinical trials for B-cell malignancies over time across the US and unique clinical trial opportunities i.e. individual clinical trials for the given diagnosis at a site that patients may have access to participate. Methods: We abstracted data from clinicaltrials.gov for all trials that had non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) as an inclusion indication between 1999-2018. Clinical trial characteristics and distribution over US geographical divisions (West, Midwest, Northeast, and South) were studied, and differences were assessed by Chi-square test. Results: A total of 1930 trials were identified (NHL: 982, MM: 948), of which 483 were recruiting at the time of data abstraction (NHL: 250, MM: 233). Over the past 2 decades, 182691 patients were enrolled on the various trials (NHL: 81592, MM: 101099). Trials by phase of study included phase 1: 629, phase 1/2: 316, phase 2: 813, phase 2/3: 11 and phase 3: 161. Number of trials by phase separated by NHL and MM are shown in Figure 1. Of these, 197 trials were randomized (NHL: 67, MM: 130). Geographical distribution of trials by diagnosis type is shown in Figure 2. A total of 31806 unique trial opportunities were noted for MM and NHL, of which 9,513 were international and 22,293 were in the US, with a geographical distribution of 5080 in West, 8198 in Midwest, 3944 in Northeast, and 5071 in South. 4,883 of the unique trial opportunities were available at NCI/NCCN accredited sites and 17,410 were at non-NCI/NCCN sites in the US. Treatment characteristics of the trials included monoclonal antibodies in 1218, other targeted agents in 2641, stem cell transplant in 526, and other agents in 517 trials with several trials utilizing more than one of these therapeutic options. There was no statistically significant difference in the distribution of clinical trials by phase of study across various US geographical regions for MM (p=0.71), NHL (p=0.98) or combined MM+NHL (p=0.16). On the other hand, unique trial opportunities were significantly different by study phase and geographical distribution for MM, NHL or MM+NHL (all p<0.001) (Figure 3). Conclusions: Widespread access to clinical trials within a cancer diagnosis is imperative for generalizability of trial results. In a comprehensive, national analysis we noted that while it may appear that clinical trials are available across the US, sites where they are open are distributed unevenly, giving rise to a disparity in access to evidence-based therapeutic advancements for patients. Disclosures Ailawadhi: Janssen: Consultancy; Amgen: Consultancy; Pharmacyclics: Research Funding; Takeda: Consultancy; Celgene: Consultancy. Sher:Affimed: Research Funding.

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