Crews, Jennie R.

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.

6530 Background: Only a small fraction of patients with cancer participate in treatment trials. Patients identifying as members of racial and ethnic minority groups are consistently underrepresented in these trials. A recent systematic review reported that patients, regardless of race and ethnicity, are willing to enroll in trials if asked to participate by their treating clinician. Prospective and longitudinal data and metrics at the site- and clinician-level are necessary to understand whether patients are equitably considered for clinical trials. Methods: ASCO and Association of Community Cancer Centers (ACCC) developed a self-assessment for trial sites to record and gauge the number of patients across races and ethnicities screened, offered, and enrolled into clinical trials. Research sites, from across the US, were recruited through an open call to apply to participate in the ASCO-ACCC Pilot Project. There were 65 sites assigned to this pilot study, which tested the feasibility and utility of the site assessment. Sites were asked to enter 2019 and 2020 aggregate data for each step along the clinical trial enrollment continuum by select races and ethnicities (Black, Hispanic/Latinx, White) and overall. Results: 62 of 65 sites completed the study and represented a range of settings and practice types (61% academic, 26% hospital/health system, 13% independent). Only 2 sites (3%) were able to provide the data requested at each enrollment step in the assessment (table). Sites that collected the data did not do so routinely (table) and most had to compile data through multiple sources and/or manual extraction (40-100% across enrollment steps). Sites with missing data reported they did not collect data at all (36-64% across enrollment steps), did not collect data in a systematic way (0-29% across enrollment steps), or stated it would be too burdensome to manually review charts to extract data (12-29% across enrollment steps). Conclusions: Data collection and routine evaluation of participation metrics, by race and ethnicity, are necessary to assess and monitor equity and diversity in clinical trials. Most sites in this study did not collect, or routinely collect, data for screening, offering, and consenting patients to clinical trials. Without these data, sites are unable to evaluate and monitor whether their patients have equitable access to clinical trials or establish strategies to address any inequities. ASCO and ACCC will continue to partner with sites to better understand their processes and the feasibility of collecting such data in a systematic and automated way, such as through electronic health record systems. [Table: see text]

A concerted commitment across research stakeholders is necessary to increase equity, diversity, and inclusion (EDI) and address barriers to cancer clinical trial recruitment and participation. Racial and ethnic diversity among trial participants is key to understanding intrinsic and extrinsic factors that may affect patient response to cancer treatments. This ASCO and Association of Community Cancer Centers (ACCC) Research Statement presents specific recommendations and strategies for the research community to improve EDI in cancer clinical trials. There are six overarching recommendations: (1) clinical trials are an integral component of high-quality cancer care, and every person with cancer should have the opportunity to participate; (2) trial sponsors and investigators should design and implement trials with a focus on reducing barriers and enhancing EDI, and work with sites to conduct trials in ways that increase participation of under-represented populations; (3) trial sponsors, researchers, and sites should form long-standing partnerships with patients, patient advocacy groups, and community leaders and groups; (4) anyone designing or conducting trials should complete recurring education, training, and evaluation to demonstrate and maintain cross-cultural competencies, mitigation of bias, effective communication, and a commitment to achieving EDI; (5) research stakeholders should invest in programs and policies that increase EDI in trials and in the research workforce; and (6) research stakeholders should collect and publish aggregate data on racial and ethnic diversity of trial participants when reporting results of trials, programs, and interventions to increase EDI. The recommendations are intended to serve as a guide for the research community to improve participation rates among people from racial and ethnic minority populations historically under-represented in cancer clinical trials. ASCO and ACCC will work at all levels to advance the recommendations in this publication.

Purpose To provide formal expert consensus–based recommendations to practicing oncologists and others on the management of brain metastases for patients with human epidermal growth factor receptor 2 (HER2) –positive advanced breast cancer. Methods The American Society of Clinical Oncology (ASCO) convened a panel of medical oncology, radiation oncology, guideline implementation, and advocacy experts and conducted a systematic review of the literature. When that failed to yield sufficiently strong quality evidence, the Expert Panel undertook a formal expert consensus–based process to produce these recommendations. ASCO used a modified Delphi process. The panel members drafted recommendations, and a group of other experts joined them for two rounds of formal ratings of the recommendations. Results No studies or existing guidelines met the systematic review criteria; therefore, ASCO conducted a formal expert consensus–based process. Recommendations Patients with brain metastases should receive appropriate local therapy and systemic therapy, if indicated. Local therapies include surgery, whole-brain radiotherapy, and stereotactic radiosurgery. Treatments depend on factors such as patient prognosis, presence of symptoms, resectability, number and size of metastases, prior therapy, and whether metastases are diffuse. Other options include systemic therapy, best supportive care, enrollment onto a clinical trial, and/or palliative care. Clinicians should not perform routine magnetic resonance imaging (MRI) to screen for brain metastases, but rather should have a low threshold for MRI of the brain because of the high incidence of brain metastases among patients with HER2-positive advanced breast cancer.