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Figure A1. Full Clinical Trial Assessment of Infrastructure Matrix tool.  

Figure A1. Full Clinical Trial Assessment of Infrastructure Matrix tool.  

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Purpose: Several publications have described minimum standards and exemplary attributes for clinical trial sites to improve research quality. The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) developed the clinical trial Best Practice Matrix tool to facilitate research program improvements through annual self-assessments...

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... Among the most powerful barriers to broader inclusion of communities of color in clinical trials are social determinants of health [15], trustworthiness of health care providers and research institutions [11,16], and competing pressures on potential participants [17][18][19][20][21]. Despite this evidence, current tools to assess organizational capabilities for clinical trial diversity focus primarily on trial infrastructure, rely solely on quantitative self-reported data, and do not include meaningful assessment of capabilities related to community engagement [22][23][24][25]. Recent guidance including a toolkit with logic models aimed to help operationalize guidance with clearly defined scopes for distinct areas of focus; however, as stated in the guide, logic models may overlook intersectionality between interrelated domains of the clinical research enterprise, within a particular organization or between organizations [10]. ...
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Background Among the most powerful barriers to broader inclusion of diverse participants in clinical trials are social determinants of health, trustworthiness of health care providers and research institutions, and competing pressures on potential participants. Nevertheless, current tools to assess organizational capabilities for clinical trial diversity focus primarily on trial infrastructure, rely solely on quantitative self-reported data, and lack meaningful assessment of capabilities related to community engagement. Methods The Equitable Breakthroughs in Medicine (EQBMED) initiative developed a holistic, collaborative, site-driven formative model and accompanying assessment to catalog sites’ current capabilities and identify opportunities for growth in both conducting industry-sponsored clinical trials and enriching diversity of those trials. The model builds upon prior work and reflects unification of two historically distinct components—research operations and community engagement—since sustainable clinical trial diversity efforts must overcome these silos. Here we present the methodology we used to develop the model and accompanying assessment, describe how findings can support clinical trial diversity efforts, and report findings from early field testing at three U.S. sites. Results The first three sites were diverse in size (e.g., < 250–1 K beds), with varying levels of clinical trial capabilities and community engagement. The maturity assessment laid the foundation for sites to identify and prioritize key areas to advance clinical trial diversity capabilities, and each has made tangible progress. In parallel to completing the assessment with these early sites to understand their maturity and set actionable goals, we also collected their feedback on content validity (e.g., clarity, comprehensiveness, terminology) and feasibility (e.g., ability to collect needed information and data, time required). We describe refinements made to improve the assessment and streamline the process. The EQBMED program will deploy the assessment across various site types (e.g., FQHCs, safety net hospitals) and make further refinements as warranted. Conclusions Strategic investment in clinical trial diversity requires structured assessment of site maturity as a starting point for collaborative action. We propose the EQBMED maturity model as a first step toward informing efforts to increase representation of diverse populations in clinical research.
... Recent programs and initiatives implemented to increase awareness of cancer clinical trials among Black/African American patients have recognized that awareness must be addressed at multiple levels of influence to advance health equity. For example, a June 2022 article published by the American Society of Clinical Oncology suggests that clinics and health care facilities use 1 of 2 standardized clinic self-assessment tools to review their enrollment practices and patient-, provider-, and system-level barriers to clinical trial enrollment [52][53][54][55][56]. ...
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Background Black/African American adults are underrepresented in oncology clinical trials in the United States, despite efforts at narrowing this disparity. Objective This study aims to explore differences in how Black/African American oncology patients perceive clinical trials to improve support for the clinical trial participation decision-making process. Methods As part of a larger randomized controlled trial, a total of 244 adult oncology patients receiving active treatment or follow-up care completed a cross-sectional baseline survey on sociodemographic characteristics, clinical trial knowledge, health literacy, perceptions of cancer clinical trials, patient activation, patient advocacy, health care self-efficacy, decisional conflict, and clinical trial intentions. Self-reported race was dichotomized into Black/African American and non–Black/African American. As appropriate, 2-tailed t tests and chi-square tests of independence were used to examine differences between groups. Results Black/African American participants had lower clinical trial knowledge (P=.006), lower health literacy (P<.001), and more medical mistrust (all P values <.05) than non–Black/African American participants. While intentions to participate in a clinical trial, if offered, did not vary between Black/African American and non–Black/African American participants, Black/African American participants indicated lower awareness of clinical trials, fewer benefits of clinical trials, and more uncertainty around clinical trial decision-making (all P values <.05). There were no differences for other variables. Conclusions Despite no significant differences in intent to participate in a clinical trial if offered and high overall trust in individual health care providers among both groups, beliefs persist about barriers to and benefits of clinical trial participation among Black/African American patients. Findings highlight specific ways that education and resources about clinical trials could be tailored to better suit the informational and decision-making needs and preferences of Black/African American oncology patients.
... [10][11][12][13][14][15][16] Such tools are often specific to a therapeutic area or type of research program 17 ; address patient-based barriers only 18 ; and/or are designed to raise awareness and educate patients, providers, and/or communities. 12,[19][20][21][22] To our knowledge, existing initiatives do not provide tools that enable different types of trial sites to evaluate their programs, policies, and procedures for equity, diversity, and inclusion (EDI) and/or assess their performance in EDI participation metrics collection, evaluation, and monitoring along the continuum of clinical trial screening, offering, and enrolling patients on trials. ...
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Clinical trial participants do not reflect the racial and ethnic diversity of people with cancer. ASCO and the Association of Community Cancer Centers collaborated on a quality improvement study to enhance racial and ethnic equity, diversity, and inclusion (EDI) in cancer clinical trials. The groups conducted a pilot study to examine the feasibility, utility, and face validity of a two-part clinical trial site self-assessment to enable diverse types of research sites in the United States to (1) review internal data to assess racial and ethnic disparities in screening and enrollment and (2) review their policies, programs, procedures to identify opportunities and strategies to improve EDI. Overall, 81% of 62 participating sites were satisfied with the assessment; 82% identified opportunities for improvement; and 63% identified specific strategies and 74% thought the assessment had potential to help their site increase EDI. The assessment increased awareness about performance (82%) and helped identify specific strategies (63%) to increase EDI in trials. Although most sites (65%) were able to provide some data on the number of patients that consented, only two sites were able to provide all requested trial screening, offering, and enrollment data by race and ethnicity. Documenting and evaluating such data are critical steps toward improving EDI and are key to identifying and addressing disparities more broadly. ASCO and Association of Community Cancer Centers will partner with sites to better understand their processes and the feasibility of collecting screening, offering, and enrollment data in systematic and automated ways.
... Subsequently, NCI launched AccrualNet, a searchable database of hundreds of journal articles with the main aim of helping clinical trial professionals in recruiting and retaining clinical trial participants, attaining accrual goals, and achieving primary endpoints [15]. In 2011, NCI Community Cancer Centers Program (NCCCP) developed the clinical trial best practice matrix tool, now renamed as Clinical Trial Assessment of Infrastructure Matrix, to facilitate research program improvements through annual self-assessments and benchmarking [16]. The tool identified nine attributes, each with three subsequent levels, to score clinical trial infrastructural elements. ...
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Purpose The aim of this study is to determine the rate of prematurely terminated clinical trials (CTs) and describe primary reasons and characteristics, and suggest strategies to improve. Methods We performed a retrospective, observational, cross-sectional study including all CTs registered in the Spanish Registry of Clinical Studies (REec) from January 1, 2013 to November 31, 2021. A descriptive analysis of reasons for premature termination was made. To assess characteristics associated with a premature termination, the relative risks (RR) with a 95% confidence interval were calculated. Results In total, 21% (718) of CT were prematurely terminated. Reasons for premature termination included patient recruitment issues in 25% (179) of cases, efficacy or futility problems in 18% (132), and commercial or strategic decisions from the sponsor in 12% (87). Characteristics significantly associated with an increased risk of premature termination included the following: presence of placebo (RR 2.08); multiple study sites (RR 1.32); pediatric and geriatric populations (RR 1.29 children; RR 1.47 preschoolers; RR 1.92 newborns; RR 1.27 > 64 years of age). In addition, circumstances such as investigations in phase II (RR 1.21), of cancer (RR 1.37), and of digestive pathology (RR 1.65) were also associated with increased risk of premature termination. Conclusion Recruitment of the study subjects in a CT must be meticulous and account for age of participants. In addition, CT study sites should be evaluated to ensure they have appropriate resources and the desired patient population. Based on intermediate analyses, CT protocols should describe the criteria to terminate a study due to futility. These approaches are essential to avoid harm to participants, ensure internal validity of studies, and improve the use of resources in CT development.
... The value of a dedicated assessment tool to benchmark clinical trial infrastructure is currently being explored. 89 For several reasons, enrolling patients into clinical trials becomes even more difficult if the respective disease is diagnosed and treated in a multidisciplinary fashion. Tailoring diagnosis and treatment strategies to individual patients with brain tumors is commonly believed to be done best in a multidisciplinary tumor board, which a priori requires additional resources from all departments involved. ...
Article
Many factors contribute to the poor survival of malignant brain tumor patients, some of which are not easily remedied. However, one contributor to the lack of progress that may be modifiable is poor clinical trial accrual. Surveys of brain tumor patients and neuro-oncology providers suggest that clinicians do a poor job of discussing clinical trials with patients and referring patients for clinical trials. Yet, data from the Cancer Action Network of the American Cancer Society suggest that most eligible oncology patients asked to enroll on a clinical trial will agree to do so. To this end, the Society for Neuro-Oncology (SNO) in collaboration with the Response Assessment in Neuro-Oncology (RANO) Working Group, patient advocacy groups, clinical trial cooperative groups including the Adult Brain Tumor Consortium (ABTC), and other partners are working together with the intent to double clinical trial accrual over the next five years. Here we describe the factors contributing to poor clinical trial accrual in neuro-oncology and offer possible solutions.
... To that end, the National Cancer Institute National Community Cancer Centers Program has created a self-assessment tool to enable administrators to identify gaps in practice capacity and then to benchmark and strengthen their trial infrastructure. 23 Step 3: Explain Standard Treatment Versus Trial to Patient ...
Article
Cancer clinical trials are critical for testing new treatments, yet less than 5% of patients with cancer enroll in these trials. Minority groups, elderly individuals, and rural populations are particularly underrepresented in cancer treatment trials. Strategies for advancing equity in cancer clinical trials for these populations include (1) optimizing clinical trial matching by broadening eligibility criteria, screening all patients for trial eligibility, expanding the number of trials against which patients are screened, and following up on all patient matches with an enrollment invitation; (2) conducting site self-assessments to identify clinical-, patient-, provider-, and system-level barriers that contribute to low rates of clinical trial screening and enrollment; (3) creating a quality improvement plan that addresses the barriers to enrollment and incorporates the use of tools and strategies such as clinical trial checklists; workforce development and trainings to improve cultural competence and reduce unconscious bias; guides to promote community education, outreach and engagement with cancer clinical trials; screening and accrual logs designed to measure participation by demographics; models of informed consent that improve understanding; clinical trial designs that reduce accessibility barriers; use of cancer clinical trial patient navigators; and programs to eliminate barriers to participation and out-of-pocket expenses; and (4) working with stakeholders to develop both protocols that are inclusive of diverse populations' geographic locations, and strategies to access those trials. These actions will support greater access for populations that have remained underrepresented in cancer clinical trials and thereby increase the generalizability and efficiency of cancer research.
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Current knowledge about mechanisms and interventions for pain has largely been derived from samples that are healthier, wealthier, younger, and more likely to be White than the general population. Failure to conduct inclusive pain research not only restricts generalizability and application of findings, but also hampers the discovery of mechanisms and the development of measures and interventions that are valid across population subgroups. Most of all, inclusive practices are critical to ensure that underrepresented groups derive equitable benefit from pain research. Here, we provide guidance for the pain research community on how to adopt inclusive research practices. We define “inclusion” to encompass a range of identities and characteristics, including racialized group/ethnicity, disability status, gender identity, sexual orientation, and age. We first describe principles relevant to promoting inclusion in pain research, including attention to: 1) stakeholder engagement; 2) structural factors underlying inequities; 3) the limitations of “disparity” research; 4) intersectionality; and 5) universal design. Next, we provide checklists with practical strategies for making studies more inclusive at each stage of the research process. We conclude by calling for system-level changes to ensure that the future of pain research is socially just, scientifically productive, and responsive to the needs of all people. Perspective : This paper offers guidance on promoting inclusion of underrepresented groups in pain research. We describe principles relevant to conducting more inclusive research; e.g., attention to stakeholder engagement, structural factors, and universal design. We provide checklists with practical strategies for inclusion at each stage of the research process.
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Objectives To describe the evolution and structure of the National Cancer Institute clinical trials programs, their notable accomplishments, nurses’ roles in these accomplishments, and the essential role of nursing today and in the future. Data Sources Manuscripts, government publications, websites, and professional communications. Conclusion Change is inevitable and a constant factor in the world of advancing science and clinical research. Nurses’ contribution to research and evidence-based practice will continue to grow and is vital as the scientific landscape evolves. Implications for Nursing Practice As the understanding of cancer biology increases and clinical trials evolve, nurses will need to remain key team members and leaders in National Cancer Institute Community Oncology Research Program and National Cancer Trials Network trials and their associated infrastructure.