Early-Phase Clinical Trials In The Community: Results From the National Cancer Institute Community Cancer Centers Program Early-Phase Working Group Baseline Assessment

Zaren, Howard A.; Nair, Suresh; Go, Ronald S.; Enos, Rebecca A.; Lanier, Keith S.; Thompson, Michael A.; Zhao, Jinxiu; Fleming, Deborah L; Leighton, John; Gribbin, Thomas; Bryant, Donna; Carrigan, Angela; Corpening, Jennifer C.; Csapo, Kimberly A.; Dimond, Eileen; Ellison, Christie; González, M. M.; Harr, Jodi; Wilkinson, Kathy; Denicoff, Andrea

doi:10.1200/jop.2012.000695

Cited by 10 publications

(7 citation statements)

References 18 publications

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“…36 In addition, changes in the health care environment have resulted in increasingly narrow networks: many insurance plans limit the providers and sites available to enrollees, with the narrowest networks typically excluding academic centers. Historically, early-phase (especially phase 1) clinical trials have been conducted by academic sites more often than community sites.…”

Section: Discussionmentioning

confidence: 99%

“…This is due to the ability of academic sites to provide infrastructure to support the increased demands of early-phase trial conduct, including increased personnel, specialized equipment, and adequate treatment space. 36 In addition, changes in the health care environment have resulted in increasingly narrow networks: many insurance plans limit the providers and sites available to enrollees, with the narrowest networks typically excluding academic centers. 37 There may be 2 possible explanations for the association between conducting precertification and experiencing denials.…”

Section: Discussionmentioning

confidence: 99%

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Insurance denials for cancer clinical trial participation after the Affordable Care Act mandate

Mackay

Antonelli

Bruinooge

et al. 2017

Cancer

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Despite the ACA's mandate for most insurers to cover routine care costs for cancer clinical trial participation, denials and delays continue. Denials may continue because some insurers remain exempt from the law, or they may signal an implementation failure. Delays in coverage may affect patient participation in trials. Additional efforts to eliminate this barrier will be needed to achieve federal initiatives to double the pace of cancer research over the next 5 years. Future work should assess the law's effectiveness at the patient level to inform these efforts. Cancer 2017;123:2893-900. © 2017 American Cancer Society.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Insurance denials for cancer clinical trial participation after the Affordable Care Act mandate

Mackay

Antonelli

Bruinooge

et al. 2017

Cancer

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“…We performed logistic regression models to identify predictors of concordance with breast and colon cancer quality measures. Since NCCCP sites are heterogeneous in terms of urban/rural status, data management, infrastructure, and funding source , we accounted for intragroup correlation within community hospitals using Stata's cluster option. We performed logistic regression models for the main effects of RQRS time period and patient characteristics for each quality measure (Model 1 in Table ).…”

Section: Methodsmentioning

confidence: 99%

The National Cancer Institute Community Cancer Centers Program (NCCCP): Sustaining Quality and Reducing Disparities in Guideline-Concordant Breast and Colon Cancer Care

et al. 2017

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This study builds on analyses performed as part of an original comprehensive National Cancer Institute Community Cancer Centers Program evaluation and examines improvements in quality of care. The following research questions are addressed: (a) have improvements in concordance rates with the five quality of care measures been sustained since 2010 and (b) how does the change in concordance for minority/underserved patients compare to the change for nonminority/nonunderserved patients through 2013?

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“…Accrual to early phase trials across the network was evaluated, as was the infrastructure to conduct these trials at each of the sites. 18 A checklist was created to assist sites in evaluating resources and staff needs for early phase trial implementation. 19 Sites with established early phase trial programs were generally those with decades of CT experience and sound infrastructures.…”

Section: Four Strategies To Enhance Research Culturementioning

confidence: 99%

Creating a “culture of research” in a community hospital: Strategies and tools from the National Cancer Institute Community Cancer Centers Program

et al. 2015

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BackgroundThe value of community-based cancer research has long been recognized. In addition to the National Cancer Institute’s Community Clinical and Minority-Based Oncology Programs established in 1983, and 1991 respectively, the National Cancer Institute established the National Cancer Institute Community Cancer Centers Program in 2007 with an aim of enhancing access to high-quality cancer care and clinical research in the community setting where most cancer patients receive their treatment. This article discusses strategies utilized by the National Cancer Institute Community Cancer Centers Program to build research capacity and create a more entrenched culture of research at the community hospitals participating in the program over a 7-year period.MethodsTo facilitate development of a research culture at the community hospitals, the National Cancer Institute Community Cancer Centers Program required leadership or chief executive officer engagement; utilized a collaborative learning structure where best practices, successes, and challenges could be shared; promoted site-to-site mentoring to foster faster learning within and between sites; required research program assessments that spanned clinical trial portfolio, accrual barriers, and outreach; increased identification and use of metrics; and, finally, encouraged research team engagement across hospital departments (navigation, multidisciplinary care, pathology, and disparities) to replace the traditionally siloed approach to clinical trials.LimitationsThe health-care environment is rapidly changing while complexity in research increases. Successful research efforts are impacted by numerous factors (e.g. institutional review board reviews, physician interest, and trial availability). The National Cancer Institute Community Cancer Centers Program sites, as program participants, had access to the required resources and support to develop and implement the strategies described. Metrics are an important component yet often challenging to identify and collect. The model requires a strong emphasis on outreach that challenges hospitals to improve and expand their reach, particularly into underrepresented populations and catchment areas. These efforts build on trust and a referral pipeline within the community which take time and significant commitment to establish.ConclusionThe National Cancer Institute Community Cancer Centers Program experience provides a relevant model to broadly address creating a culture of research in community hospitals that are increasingly networked via systems and consortiums. The strategies used align well with the National Cancer Institute—American Society of Clinical Oncology Accrual Symposium recommendations for patient-/community-, physician-/provider-, and site-/organizational-level approaches to clinical trials; they helped sites achieve organizational culture shifts that enhanced their cancer research programs. The National Cancer Institute Community Cancer Centers Program hospitals reported that the strategies were challenging to ...

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Early-Phase Clinical Trials In The Community: Results From the National Cancer Institute Community Cancer Centers Program Early-Phase Working Group Baseline Assessment

Abstract: Community cancer centers are capable of conducting EP trials. Infrastructure and collaborations are critical components of success. This assessment provides useful information for implementing EP trials in the community.

Cited by 10 publications

References 18 publications

Insurance denials for cancer clinical trial participation after the Affordable Care Act mandate

Insurance denials for cancer clinical trial participation after the Affordable Care Act mandate

The National Cancer Institute Community Cancer Centers Program (NCCCP): Sustaining Quality and Reducing Disparities in Guideline-Concordant Breast and Colon Cancer Care

Creating a “culture of research” in a community hospital: Strategies and tools from the National Cancer Institute Community Cancer Centers Program

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