Implementing Clinical Trials: A Review of the Attributes of Exemplary Clinical Trial Sites

Baer, Allison R.; Cohen, Gary I.; Smith, Dee Anna; Zoň, Robin

doi:10.1200/jop.2010.000156

Cited by 12 publications

(3 citation statements)

References 4 publications

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“…1 However, many doctors identify clinical trials as one of the most difficult areas of discussion in a consultation, [2][3][4] so it is not surprising that trials may be offered only to patients they deem ideal candidates. [5][6][7] Patients require their own time, first to confront a new cancer diagnosis or recurrence, and then to process it sufficiently so they can make decisions about treatment.…”

Section: Introductionmentioning

confidence: 99%

Power of an Effective Clinical Conversation: Improving Accrual Onto Clinical Trials

Parreco

DeJoice

Massett

et al. 2012

JOP

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The National Cancer Institute (NCI) is actively transforming clinical trials to revitalize the clinical trials system and improve patient accrual. For more than 30 years, NCI has provided information and communication resources about cancer clinical trials. The Institute supports a clinical trials Web site (www.cancer.gov/clinicaltrials) that receives nearly a half million page views a month. In addition, NCI's Cancer Information Service (800-4-CANCER, chat and e-mail) responds to 1,750 clinical trial inquiries every month. Although these numbers suggest that a high volume of clinical trial information is being exchanged between NCI, the public, and providers, most patients decide whether to participate in clinical trials during the patient-provider interaction.

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Section: Introductionmentioning

confidence: 99%

Power of an Effective Clinical Conversation: Improving Accrual Onto Clinical Trials

Parreco

DeJoice

Massett

et al. 2012

JOP

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“…Enrollment in CTs is important for improving NSCLC care [18]. However, the clinical benefit of CT enrollment remains controversial [16,17,19].…”

Section: Discussionmentioning

confidence: 99%

Survival of Patients with Advanced Non-Small Cell Lung Cancer Enrolled in Clinical Trials

et al. 2016

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Background: Up-to-date oncological therapy has been accomplished through the results of clinical trials (CTs). We analyzed the overall survival (OS) of patients with non-small cell lung cancer (NSCLC) and its relation to CT enrollment. Methods: The study included 1,042 patients with advanced NSCLC treated at the Instituto Nacional de Cancerología. All patients received treatment according to the national and international guidelines. Data were collected from medical records. Patients were subgrouped on the basis of their CT enrollment as follows: participants in any CT (ACT), exclusively intervention CTs (ICT) or exclusively pharmaceutical-sponsored CTs (PCT). Results: The CT enrollment effect was assessed through a multivariate Cox proportional hazards model. Thirty percent of the patients were in ACT, 28.3% in ICT and 13.7% in PCT. Female gender (p = 0.001), adenocarcinoma histology (p = 0.018), positive EGFR mutation (p = 0.006), and better ECOG performance status (<2) (p ≤ 0.0001) were more frequent in patients enrolled in CT; further, tobacco smoking (p ≤ 0.0001) and KRAS mutation (p = 0.001) were more frequent in patients who were not enrolled in a CT. Conclusion: Enrollment in ACT was associated with a better OS (hazard ratio: 0.47-0.74). NSCLC patients enrolled in a CT have an improved survival in an independent manner to other prognostic factors.

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“…ASCO supported a series of articles addressing minimum standards and exemplary attributes of CT sites. 14 – 16 These articles were used by the CT Subcommittee to conceptually frame and create the “Clinical Trials Assessment of Infrastructure” or “CT AIM” tool to assess site CT infrastructure. † The tool identified nine attributes, each with three assessment levels progressively moving from less to more exemplary CT infrastructure.…”

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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Implementing Clinical Trials: A Review of the Attributes of Exemplary Clinical Trial Sites

Abstract: In this two-part series, members of the Exemplary Attributes Working Group outline in detail the seven attributes of exemplary clinical trial sites, as described in the ASCO Statement.

Cited by 12 publications

References 4 publications

Power of an Effective Clinical Conversation: Improving Accrual Onto Clinical Trials

Power of an Effective Clinical Conversation: Improving Accrual Onto Clinical Trials

Survival of Patients with Advanced Non-Small Cell Lung Cancer Enrolled in Clinical Trials

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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